Recruiting
Phase 3

Dara-VCD vs. Chemotherapy

Sponsor:

SWOG Cancer Research Network

Code:

NCT06022939

Conditions

AL Amyloidosis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Autologous Hematopoietic Stem Cell Transplantation

Biopsy

Biospecimen Collection

Bone Marrow Aspiration

Bone Marrow Biopsy

Study Details

Brief summary:

This phase III trial compares the effect of adding a stem cell transplant with melphalan after completing chemotherapy with daratumumab, cyclophosphamide, bortezomib and dexamethasone (Dara-VCD) versus chemotherapy with Dara-VCD alone for treating patients with newly diagnosed amyloid light chain (AL) amyloidosis. Melphalan is a chemotherapy given prior to a stem cell transplant. Giving chemotherapy before a peripheral blood stem cell transplant helps kill cancer cells in the body and helps make room in the patient's bone marrow for new blood-forming cells (stem cells) to grow. The stem cells are then returned to the patients to replace the blood forming cells that were destroyed by the chemotherapy. Daratumumab is in a class of medications called monoclonal antibodies. It binds to a protein called CD38, which is found on some types of immune cells and cancer cells, including myeloma cells. Daratumumab may block CD38 and help the immune system kill cancer cells. Chemotherapy drugs, such as cyclophosphamide and bortezomib, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Dexamethasone is in a class of medications called corticosteroids. It is used to lower the body's immune response to help stop the growth of cancer cells. Giving a stem cell transplant with melphalan after Dara-VCD may kill more cancer cells in patients with newly diagnosed AL amyloidosis.

Conditions

AL Amyloidosis

Study ID

NCT06022939

Start date

Jul 1, 2024

Status verified date

Sep, 2025

Completion date

Oct 29, 2030

Anticipated

Primary completion date

Jul 29, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • STEP 1: Participants must have systemic AL amyloidosis which is biopsy proven and includes histologically-confirmed by positive Congo red stain with green birefringence on polarized light microscopy, OR characteristic appearance by electron microscopy AND confirmatory AL amyloid typing (mass spectrometry-based proteomic analysis or immunofluorescence). If there is question regarding diagnosis, consult study chairs prior to registration
  • STEP 1: Participants must have measurable disease within 28 days prior to treatment if initiated prior to registration or within 28 days of registration as defined by at least one of the following:

  • Positive monoclonal serum immunofixation electrophoresis
  • Positive monoclonal urine immunofixation electrophoresis
  • Monoclonal plasma cells in bone marrow In addition, participants must also have a difference between the involved and uninvolved free light chain (dFLC) >= 2 mg/dL
  • STEP 1: Participants may receive up to one cycle (or 28 days) of therapy prior to enrollment. If a patient receives >= 75% of 1 cycle of protocol identical Dara-VCD, this will be considered 1 cycle of protocol induction. Any patient who receives less than 75% of 1 cycle of Dara-VCD or non-protocol therapy will still be eligible but will be treated per protocol. If protocol identical therapy is initiated prior to enrollment, this treatment is not continued but rather treatment is dictated per protocol
  • STEP 1: Participants may be receiving chronic corticosteroids if they are being given for disorders other than AL amyloidosis or myeloma
  • STEP 1: Participant must be >= 18 years old
  • STEP 1: Participant must have Eastern Cooperative Oncology Group (ECOG) performance score (PS) of 0, 1, or 2 (PS = 3 may be allowed if secondary to neuropathy)
  • STEP 1: Participant must have a complete medical history and physical exam within 28 DAYS prior to registration
  • STEP 1: Participants must be willing to undergo high dose chemotherapy and autologous stem cell transplantation if they are randomized to the arm receiving high dose chemotherapy and autologous stem cell transplantation
  • STEP 1: Participants must be eligible to receive high dose chemotherapy with melphalan at a dose of 200 mg/m\^2 or 140 mg/m\^2 (200 mg/m\^2 is highly encouraged but not mandated). Transplant eligibility criteria are included in the general eligibility criteria listed below:

  • Participant must have a supine systolic blood pressure (BP) >= 90 mmHg (at registration step-1, this may by supported by midodrine
  • Participant must have non-severe cardiac AL (meeting all the below criteria) as defined by:

  • N-terminal proB-type natriuretic peptide (NT proBNP) < 5000 (if no NTproBNP, brain natriuretic peptide \[BNP\] must be available and < 400)
  • Troponin T (TnT) < 0.06. If not available, one of the following two criteria must be met:

  • High sensitivity troponin (hsTnT) T < 75 or troponin I < 0.1ng/dL
  • New York Heart Association (NYHA) I or II
  • Cardiac ejection fraction (EF) >= 40%
  • STEP 1: Hemoglobin >= 8.0 g/dL (> 5 mmol/L); red blood cell transfusion allowed up to 7 day prior to registration (within 28 days prior to registration) (NOTE: Growth factor support granulocyte colony-stimulating factor \[G-CSF\] is permitted per institutional guidelines)
  • STEP 1: Leukocytes >= 2 x 10\^3/uL (within 28 days prior to registration) (NOTE: Growth factor support \[G-CSF\] is permitted per institutional guidelines)
  • STEP 1: Absolute neutrophil count >= 1.0 x 10\^3/uL (within 28 days prior to registration) (NOTE: Growth factor support \[G-CSF\] is permitted per institutional guidelines)
  • STEP 1: Platelets >= 50 x 10\^3/uL (within 28 days prior to registration) (NOTE: Growth factor support \[G-CSF\] is permitted per institutional guidelines)
  • STEP 1: Total bilirubin =< 1.5 times the institutional upper limit of normal (ULN) unless history of Gilbert's disease. Participants with history of Gilbert's disease must have total bilirubin =< 5 x institutional ULN (within 28 days prior to registration)
  • STEP 1: Direct bilirubin =< 2.0 mg/dL (within 28 days prior to registration)
  • STEP 1: Aspartate aminotransferase (AST)/ alanine aminotransferase (ALT) =< 3x upper limit of normal (ULN) (except if secondary to hepatic involvement) (within 28 days prior to registration)
  • STEP 1: Alkaline phosphatase =< 750 U/L (except if secondary to hepatic involvement) (within 28 days prior to registration)
  • STEP 1: Participants must have a serum creatinine =< the institutional (I)ULN OR measured OR calculated creatinine clearance >= 30 mL/min using the following Cockcroft-Gault formula. This specimen must have been drawn and processed within 28 days prior to registration
  • STEP 1: If peripheral neuropathy is present at diagnosis, participants must be grade 2 (moderate symptoms; limiting instrumental activity of daily living \[ADL\]) or less
  • STEP 1: Participants must have adequate cardiac function. Participants with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, must have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, participants must be class 2 or better
  • STEP 1: Participants must not be seropositive for hepatitis B (defined by a positive test for hepatitis B surface antigen \[HBsAg\]). Subjects with resolved infection (i.e., subjects who are HBsAg negative but positive for antibodies to hepatitis B core antigen \[anti-HBc\] and/or antibodies to hepatitis B surface antigen \[anti-HBs\]) must be screened using real-time polymerase chain reaction (PCR) measurement of hepatitis B virus (HBV) deoxyribonucleic acid (DNA) levels. Those who are PCR positive will be excluded. EXCEPTION: Subjects with serologic findings suggestive of HBV vaccination (anti-HBs positivity as the only serologic marker) AND a known history of prior HBV vaccination, do not need to be tested for HBV DNA by PCR
  • STEP 1: Participants with a history of hepatitis C virus (HCV) infection must have been treated and cured. Participants currently being treated for HCV infection must have undetectable HCV viral load test on the most recent test results obtained within 6 months prior to registration, if indicated
  • STEP 1: Participants must not have concurrent multiple myeloma as defined by the presence of lytic bone disease, plasmacytomas, >= 60% plasma cells in the bone marrow, or hypercalcemia. Participants will not be excluded solely based on the presence of plasma cells > 10% in the bone marrow unless the plasma cell percentage exceeds >60%
  • STEP 1: Participants must not have known allergies to any of the study drugs
  • STEP 1: Participants must not have had a major surgery within 14 days prior to registration and be fully recovered from surgery completed within 14 days prior to registration
  • STEP 1: Participants must not have a known chronic obstructive pulmonary disease with a forced expiratory volume in 1 second (FEV1) < 50% of predicted normal
  • STEP 1: Participants with known human immunodeficiency virus (HIV)-infection must be on effective anti-retroviral therapy at registration and have undetectable viral load test on the most recent test results obtained within 6 months prior to registration
  • STEP 1: Participants must not have either moderate or severe persistent asthma within the past 2 years), or currently have uncontrolled asthma of any classification. (Note that subjects who currently have controlled intermittent asthma or controlled mild persistent asthma are allowed in the study)
  • STEP 1: Participants must not have uncontrolled diabetes within 28 days prior to registration
  • STEP 1: Participants must not have uncontrolled blood pressure and hypertension within 14 days prior to registration. Participants must have a supine systolic BP of >= 90 mmHg
  • STEP 1: Participants must not have a prior or concurrent malignancy whose natural history or treatment (in the opinion of the treating physician) has the potential to interfere with the safety or efficacy assessment of the investigational regimen
  • STEP 1: Participants must not have received vaccination with live attenuated vaccines within 28 days prior to Registration to Step 1
  • STEP 1: Participants must not have uncontrolled infection at the discretion of the enrolling physician and to be discussed with the study chair if the participant is on active anti-infectious therapy. Any patient on active anti-microbial therapy for chronic infectious issues should be discussed with the study chair prior to enrollment
  • STEP 1: Participants must not be pregnant or nursing (nursing includes breast milk fed to an infant by any means, including from the breast, milk expressed by hand, or pumped). Individuals who are of reproductive potential must have agreed to use an effective contraceptive method with details provided as a part of the consent process. A person who has had menses at any time in the preceding 12 consecutive months or who has semen likely to contain sperm is considered to be of "reproductive potential." In addition to routine contraceptive methods, "effective contraception" also includes refraining from sexual activity that might result in pregnancy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) including hysterectomy, bilateral oophorectomy, bilateral tubal ligation/occlusion, and vasectomy with testing showing no sperm in the semen
  • STEP 1: Participants must be offered the opportunity to participate in specimen banking. With participant consent, specimens must be collected and submitted via the Southwestern Oncology group (SWOG) Specimen Tracking System
  • STEP 1: Participants must agree to have blood, bone marrow core biopsy and aspirate, and fat pad biopsy specimens submitted for minimal residual disease assessment and future exploratory studies
  • STEP 1: Participants who can complete PRO, QOL, PRO-CTCAE questionnaires, etc. forms in English, Spanish and French must participate in the patient-reported outcomes and quality of life
  • STEP 2: Participants must have met all eligibility criteria for Step-1 registration
  • STEP 2: Participants must have achieved at least a partial response
  • STEP 2: Participants must continue receiving at least one of study drugs (bortezomib, cyclophosphamide, or daratumumab and hyaluronidase-fihj) if another study drug (daratumumab and hyaluronidase-fihj, cyclophosphamide, or bortezomib) has been discontinued due to adverse events. Note: daratumumab and hyaluronidase-fihj cannot be permanently discontinued
  • STEP 2: Participants must have completed induction therapy
  • STEP 2: Participants must be registered to Step 2 within 42 days of cycle 3, day 28 of induction therapy
  • STEP 2: Participants must plan to initiate their assigned consolidation therapy within 8 weeks after randomization
  • STEP 2: Participants must not have experienced a MOD-PFS event
  • STEP 2: Participants must have ECOG performance score (PS) of 0, 1, or 2 (PS = 3 may be allowed if secondary to neuropathy)
  • STEP 2: Participant must have a complete medical history and physical exam within 28 days prior to registration
  • STEP 2: Participants must be willing to undergo high dose chemotherapy and autologous stem cell transplantation if they are randomized to the arm receiving high dose chemotherapy and autologous stem cell transplantation
  • STEP 2: Participants randomized to Arm 2 must be willing and able to return to a participating treatment center for their assigned treatment after transplant. Note that participants need not to have a direct relationship with the transplant center in order to register
  • STEP 2: Participants must be eligible to receive high dose chemotherapy with melphalan at a dose of 200 mg/m\^2 or 140 mg/m\^2 (200 mg/m\^2 is highly encouraged but not mandated). Transplant eligibility criteria are included in the general eligibility criteria listed below:

  • Patient must have a supine systolic BP >= 90 mmHg (at registration step-1, this may not by supported by midodrine)
  • Patient must have non-severe cardiac AL as defined by:

  • NT proBNP <5000 (if no NTproBNP, BNP must be available and < 400 pg/mL) (within 14 days prior to registration step-2)
  • TnT < 0.06. If not available, one of the following two criteria must be met (within 14 days prior to registration step-2)

  • hsTnT <75 or troponin I < 0.1ng/dL
  • NYHA I or II (within 14 days prior to registration step-2)
  • Cardiac EF >= 40% (within 14 days prior to registration step-2)
  • STEP 2: Hemoglobin > 8.0 g/dL (> 5 mmol/L); red blood cell transfusion allowed up to 7 days prior to registration (within 28 days prior to registration) (NOTE: Growth factor support \[G-CSF\] is permitted per institutional guidelines)
  • STEP 2: Leukocytes >= 2 x 10\^3/uL (within 28 days prior to registration) (NOTE: Growth factor support \[G-CSF\] is permitted per institutional guidelines)
  • STEP 2: Absolute neutrophil count >= 1.0 x 10\^3/uL (within 28 days prior to registration) (NOTE: Growth factor support \[G-CSF\] is permitted per institutional guidelines)
  • STEP 2: Platelets >= 50 x 10\^3/uL (within 28 days prior to registration) (NOTE: Growth factor support \[G-CSF\] is permitted per institutional guidelines)
  • STEP 2: Total bilirubin =< 1.5 times the institutional ULN unless history of Gilbert's disease. Participants with history of Gilbert's disease must have total bilirubin =< 5 x institutional ULN (within 28 days prior to registration)
  • STEP 2: Direct bilirubin =< 2.0 mg/dL (except if secondary to hepatic involvement) (within 28 days prior to registration)
  • STEP 2: AST/ALT =< 3x upper limit of normal (ULN) (except if secondary to hepatic involvement) (within 28 days prior to registration)
  • STEP 2: Alkaline phosphatase =< 750 U/L (except if secondary to hepatic involvement) (within 28 days prior to registration)
  • STEP 2: Participants must have a serum creatinine =< the IULN OR calculated creatinine clearance ≥ 30 mL/min using the following Cockcroft-Gault Formula. This specimen must have been drawn and processed within 28 days prior to registration
  • STEP 2: Participants must not have uncontrolled infection at the discretion of the enrolling physician and to be discussed with the study chair if the participant is on active anti-infectious therapy. Any patient on active anti-microbial therapy for chronic infectious issues should be discussed with the study chair prior to enrollment
  • STEP 2: Participants randomized to the ASCT arm must be able to have at least 2.0 x 10\^6 CD34 cells/kg collected
  • STEP 2: Participants who can complete PRO, QOL, PRO-CTCAE questionnaires, etc. forms in English, Spanish and French must participate in the patient-reported outcomes and quality of life
  • STEP 3: Participants must have met all eligibility criteria for Step-1 and Step-2 registration
  • STEP 3: Participants must not have had daratumumab and hyaluronidase-fihj permanently discontinued during induction or consolidation
  • STEP 3: Participants must have completed induction and consolidation therapy
  • STEP 3: Participants must be registered to Step 3 within the following time frames:

  • If randomized to Arm 1 Dara-VCD consolidation: within 28 days of completion of 3 cycles of consolidation therapy
  • If randomized to Arm 2 high dose chemotherapy and autologous stem cell transplantation: within 180 days following initiation of stem cell transplantation
  • STEP 3: Participants must not have experienced a MOD-PFS event
  • STEP 3: Participants must have ECOG performance score (PS) of 0, 1, or 2 (PS = 3 is allowed if secondary to neuropathy)
  • STEP 3: Participants must have a complete medical history and physical exam within 28 DAYS prior to registration
  • STEP 3: Hemoglobin > 8.0 g/dL (> 5 mmol/L); red blood cell transfusion allowed up to 7 days prior to registration (within 28 days prior to registration) (NOTE: Growth factor support \[G-CSF\] is permitted per institutional guidelines)
  • STEP 3: Leukocytes >= 2 x 10\^3/uL (within 28 days prior to registration) (NOTE: Growth factor support \[G-CSF\] is permitted per institutional guidelines)
  • STEP 3: Absolute neutrophil count >= 1.0 x 10\^3/uL (within 28 days prior to registration) (NOTE: Growth factor support \[G-CSF\] is permitted per institutional guidelines)
  • STEP 3: Platelets >= 50 x 10\^3/uL (within 28 days prior to registration) (NOTE: Growth factor support \[G-CSF\] is permitted per institutional guidelines)
  • STEP 3: Total bilirubin =< 1.5 times the institutional upper limit of normal (ULN) unless history of Gilbert's disease. Participants with history of Gilbert's disease must have total bilirubin =< 5 x institutional ULN (within 28 days prior to registration)
  • STEP 3: Direct bilirubin =< 2.0 mg/dL (within 28 days prior to registration)
  • STEP 3: AST/ALT =< 3x upper limit of normal (ULN) (except if secondary to hepatic involvement) (within 28 days prior to registration)
  • STEP 3: Alkaline phosphatase =< 750 U/L (except if secondary to hepatic involvement) (within 28 days prior to registration)
  • STEP 3: Participants must not have uncontrolled infection at the discretion of the enrolling physician and to be discussed with the study chair if the participant is on active anti-infectious therapy. Any patient on active anti-microbial therapy for chronic infectious issues should be discussed with the study chair prior to enrollment
  • Participants must be informed of the investigational nature of this study and must sign and give informed consent in accordance with institutional and federal guidelines.

For participants with impaired decision-making capabilities, legally authorized representatives may sign and give informed consent on behalf of study participants in accordance with applicable federal, local, and Central Institutional Review Board (CIRB) regulations

Study Design

Enrollment

338 participants

Anticipated

Allocation

Randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Consolidation Arm I (Chemotherapy)

Patients receive daratumumab and hyaluronidase-fihj SC over 3-5 minutes on days 1 and 15 as well as bortezomib SC over 3-5 minutes, cyclophosphamide PO or IV, and dexamethasone PO or IV on days 1, 8, 15 and 22 of each cycle. Cycles repeat every 28 days for up to 3 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo echocardiography at screening and at progression. Patients undergo bone marrow aspiration and biopsy within14-28 days post consolidation treatment and at progression. Patients undergo blood and urine sample collection at screening, at the start of each cycle, and the end of treatment and during follow up or at progression.

experimental: Consolidation Arm II (Chemotherapy, ASCT)

Patients undergo collection of peripheral blood stem cells. Patients receive melphalan IV for 1 cycle and then 2 days later receive the stem cell transplant IV in the absence of disease progression or unacceptable toxicity. Patients undergo echocardiography at screening and at progression. Patients undergo bone marrow aspiration and biopsy within 60-90 days post initiation of stem cell transplant. Patients undergo blood and urine sample collection at screening, during treatment, and the end of treatment and during follow up or at progression.

experimental: Induction (Chemotherapy)

Patients receive daratumumab and hyaluronidase-fihj SC over 3-5 minutes on days 1, 8, 15 and 22 for 2 cycles and then days 1 and 15 for cycle 3. Patients receive bortezomib SC over 3-5 minutes, cyclophosphamide PO or IV, and dexamethasone PO or IV on days 1, 8, 15 and 22 of each cycle. Cycles repeat every 28 days for up to 3 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo CT, MRI or PET-CT and fat pad aspiration at screening. Patients undergo echocardiography at screening, the completion of induction, and at progression. Patients undergo bone marrow aspiration and biopsy at screening, post induction treatment and at progression. Patients undergo blood and urine sample collection at screening, at the start of each cycle, and the end of treatment and during follow up or at progression.

experimental: Maintenance (daratumumab and hyaluronidase-fihj)

Patients receive maintenance daratumumab and hyaluronidase-fihj SC over 3-5 minutes on day 1 of each cycle. Cycles repeat every 28 days for up 18 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo echocardiography at screening, 12 months post consolidation treatment and at progression. Patients undergo bone marrow aspiration and biopsy 12 months post consolidation treatment and at progression. Patients undergo blood and urine sample collection at screening, during treatment, 12 months post consolidation treatment and during follow up or at progression.

Interventions

Autologous Hematopoietic Stem Cell Transplantation

Given IV

Biopsy

Undergo fat pad biopsy

Biospecimen Collection

Undergo blood and urine specimen collection

Bone Marrow Aspiration

Undergo bone marrow aspiration

Bone Marrow Biopsy

Undergo bone marrow biopsy

Bortezomib

Given SC

Computed Tomography

Undergo CT scan

Cyclophosphamide

Given PO or IV

Daratumumab and Hyaluronidase-fihj

Given SC

Dexamethasone

Given PO or IV

Echocardiography

Undergo echocardiography

Magnetic Resonance Imaging

Undergo MRI

Melphalan

Given IV

Positron Emission Tomography

Undergo PET-CT

Stem Cell Isolation

Undergo stem cell collection

Survey Administration

Ancillary study

Primary outcome measure

  • Major organ deterioration progression-free survival (PFS) [ Time Frame: From date of randomization (Step 2 registration) to date of first documentation of hematologic progression, cardiac organ progression, renal organ progression, or death due to any cause, assessed up to 4 years ]

Central Contacts and Locations

Locations

CTCA at Western Regional Medical Center

Recruiting

Goodyear, Arizona, United States, 85338

Contacts

Site Public Contact

623-207-3000

Principal Investigator:

Tibor J. Kovacsovics

Banner University Medical Center - Tucson

Recruiting

Tucson, Arizona, United States, 85719

Contacts

Site Public Contact

UACC-IIT@uacc.arizona.edu

Principal Investigator:

Muhammad Husnain

University of Arizona Cancer Center-North Campus

Recruiting

Tucson, Arizona, United States, 85719

Contacts

Site Public Contact

UACC-IIT@uacc.arizona.edu

Principal Investigator:

Muhammad Husnain

City of Hope Comprehensive Cancer Center

Recruiting

Duarte, California, United States, 91010

Contacts

Site Public Contact

800-826-4673becomingapatient@coh.org

Principal Investigator:

Michael A. Rosenzweig

UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care

Recruiting

Irvine, California, United States, 92612

Contacts

Site Public Contact

877-827-8839ucstudy@uci.edu

Principal Investigator:

Polina Bellman

City of Hope at Irvine Lennar

Recruiting

Irvine, California, United States, 92618

Contacts

Site Public Contact

877-467-3411

Principal Investigator:

Michael A. Rosenzweig

UC Irvine Health/Chao Family Comprehensive Cancer Center

Recruiting

Orange, California, United States, 92868

Contacts

Site Public Contact

877-827-8839ucstudy@uci.edu

Principal Investigator:

Polina Bellman

Smilow Cancer Hospital-Derby Care Center

Recruiting

Derby, Connecticut, United States, 06418

Contacts

Site Public Contact

203-785-5702canceranswers@yale.edu

Principal Investigator:

Terri L. Parker

Smilow Cancer Hospital Care Center at Greenwich

Recruiting

Greenwich, Connecticut, United States, 06830

Contacts

Site Public Contact

203-785-5702canceranswers@yale.edu

Principal Investigator:

Terri L. Parker

Smilow Cancer Hospital Care Center - Guilford

Recruiting

Guilford, Connecticut, United States, 06437

Contacts

Site Public Contact

203-785-5702canceranswers@yale.edu

Principal Investigator:

Terri L. Parker

Smilow Cancer Hospital Care Center at Saint Francis

Recruiting

Hartford, Connecticut, United States, 06105

Contacts

Site Public Contact

203-785-5702canceranswers@yale.edu

Principal Investigator:

Terri L. Parker

Yale University

Recruiting

New Haven, Connecticut, United States, 06520

Contacts

Site Public Contact

203-785-5702canceranswers@yale.edu

Principal Investigator:

Terri L. Parker

Yale-New Haven Hospital North Haven Medical Center

Recruiting

North Haven, Connecticut, United States, 06473

Contacts

Site Public Contact

203-785-5702canceranswers@yale.edu

Principal Investigator:

Terri L. Parker

Smilow Cancer Hospital Care Center at Long Ridge

Recruiting

Stamford, Connecticut, United States, 06902

Contacts

Site Public Contact

203-785-5702canceranswers@yale.edu

Principal Investigator:

Terri L. Parker

Smilow Cancer Hospital Care Center-Trumbull

Recruiting

Trumbull, Connecticut, United States, 06611

Contacts

Site Public Contact

203-785-5702canceranswers@yale.edu

Principal Investigator:

Terri L. Parker

MedStar Georgetown University Hospital

Recruiting

Washington D.C., District of Columbia, United States, 20007

Contacts

Site Public Contact

202-444-2223

Principal Investigator:

Kimberley Doucette

UM Sylvester Comprehensive Cancer Center at Aventura

Recruiting

Aventura, Florida, United States, 33180

Contacts

Site Public Contact

954-461-2180

Principal Investigator:

James E. Hoffman

UM Sylvester Comprehensive Cancer Center at Coral Gables

Recruiting

Coral Gables, Florida, United States, 33146

Contacts

Site Public Contact

305-243-2647

Principal Investigator:

James E. Hoffman

UM Sylvester Comprehensive Cancer Center at Coral Springs

Recruiting

Coral Springs, Florida, United States, 33065

Contacts

Site Public Contact

305-243-2647

Principal Investigator:

James E. Hoffman

UM Sylvester Comprehensive Cancer Center at Deerfield Beach

Recruiting

Deerfield Beach, Florida, United States, 33442

Contacts

Site Public Contact

305-243-2647

Principal Investigator:

James E. Hoffman

UM Sylvester Comprehensive Cancer Center at Hollywood

Recruiting

Hollywood, Florida, United States, 33021

Contacts

Site Public Contact

305-243-2647

Principal Investigator:

James E. Hoffman

University of Miami Miller School of Medicine-Sylvester Cancer Center

Recruiting

Miami, Florida, United States, 33136

Contacts

Site Public Contact

305-243-2647

Principal Investigator:

James E. Hoffman

UM Sylvester Comprehensive Cancer Center at Kendall

Recruiting

Miami, Florida, United States, 33176

Contacts

Site Public Contact

305-243-2647

Principal Investigator:

James E. Hoffman

University of Miami Sylvester Comprehensive Cancer Center at Sole Mia

Recruiting

North Miami, Florida, United States, 33181

Contacts

Site Public Contact

kginnity@med.miami.edu

Principal Investigator:

James E. Hoffman

UM Sylvester Comprehensive Cancer Center at Plantation

Recruiting

Plantation, Florida, United States, 33324

Contacts

Site Public Contact

305-243-2647

Principal Investigator:

James E. Hoffman

Emory University Hospital Midtown

Recruiting

Atlanta, Georgia, United States, 30308

Contacts

Site Public Contact

888-946-7447

Principal Investigator:

Jonathan L. Kaufman

Emory University Hospital/Winship Cancer Institute

Recruiting

Atlanta, Georgia, United States, 30322

Contacts

Site Public Contact

404-778-1868

Principal Investigator:

Jonathan L. Kaufman

Rush-Copley Medical Center

Recruiting

Aurora, Illinois, United States, 60504

Contacts

Site Public Contact

630-978-6212RCMC_Cancer_Research@rush.edu

Principal Investigator:

Priyank P. Patel

University of Illinois

Recruiting

Chicago, Illinois, United States, 60612

Contacts

Site Public Contact

312-355-3046

Principal Investigator:

Ana Maria Avila Rodriguez

Carle at The Riverfront

Recruiting

Danville, Illinois, United States, 61832

Contacts

Site Public Contact

800-446-5532Research@Carle.com

Principal Investigator:

Priyank P. Patel

Carle Physician Group-Effingham

Recruiting

Effingham, Illinois, United States, 62401

Contacts

Site Public Contact

800-446-5532Research@carle.com

Principal Investigator:

Priyank P. Patel

Carle Physician Group-Mattoon/Charleston

Recruiting

Mattoon, Illinois, United States, 61938

Contacts

Site Public Contact

800-446-5532Research@carle.com

Principal Investigator:

Priyank P. Patel

Loyola University Medical Center

Recruiting

Maywood, Illinois, United States, 60153

Contacts

Site Public Contact

708-226-4357

Principal Investigator:

Patrick A. Hagen

Carle Cancer Center

Recruiting

Urbana, Illinois, United States, 61801

Contacts

Site Public Contact

800-446-5532Research@carle.com

Principal Investigator:

Priyank P. Patel

UI Health Care Mission Cancer and Blood - Ankeny Clinic

Recruiting

Ankeny, Iowa, United States, 50023

Contacts

Site Public Contact

515-241-3305

Principal Investigator:

Seema Harichand-Herdt

UI Health Care Mission Cancer and Blood - West Des Moines Clinic

Recruiting

Clive, Iowa, United States, 50325

Contacts

Site Public Contact

515-241-3305

Principal Investigator:

Seema Harichand-Herdt

Iowa Methodist Medical Center

Recruiting

Des Moines, Iowa, United States, 50309

Contacts

Site Public Contact

515-241-6727

Principal Investigator:

Seema Harichand-Herdt

UI Health Care Mission Cancer and Blood - Des Moines Clinic

Recruiting

Des Moines, Iowa, United States, 50309

Contacts

Site Public Contact

515-241-3305

Principal Investigator:

Seema Harichand-Herdt

UI Health Care Mission Cancer and Blood - Laurel Clinic

Recruiting

Des Moines, Iowa, United States, 50314

Contacts

Site Public Contact

515-241-3305

Principal Investigator:

Seema Harichand-Herdt

UI Health Care Mission Cancer and Blood - Waukee Clinic

Recruiting

Waukee, Iowa, United States, 50263

Contacts

Site Public Contact

515-241-3305

Principal Investigator:

Seema Harichand-Herdt

University of Kansas Cancer Center

Recruiting

Kansas City, Kansas, United States, 66160

Contacts

Site Public Contact

913-588-3671KUCC_Navigation@kumc.edu

Principal Investigator:

Muhammad Umair Mushtaq

University of Kansas Hospital-Westwood Cancer Center

Recruiting

Westwood, Kansas, United States, 66205

Contacts

Site Public Contact

913-588-3671KUCC_Navigation@kumc.edu

Principal Investigator:

Muhammad Umair Mushtaq

Walter Reed National Military Medical Center

Recruiting

Bethesda, Maryland, United States, 20889-5600

Contacts

Site Public Contact

301-319-2100

Principal Investigator:

Christin Destefano

Boston Medical Center

Recruiting

Boston, Massachusetts, United States, 02118

Contacts

Site Public Contact

617-638-8265

Principal Investigator:

Vaishali Sanchorawala

University of Michigan Rogel Cancer Center

Recruiting

Ann Arbor, Michigan, United States, 48109

Contacts

Site Public Contact

800-865-1125CancerAnswerLine@med.umich.edu

Principal Investigator:

Matthew J. Pianko

Henry Ford Cancer Institute-Downriver

Recruiting

Brownstown, Michigan, United States, 48183

Contacts

Site Public Contact

313-916-3721CTOResearch@hfhs.org

Principal Investigator:

Philip Kuriakose

Henry Ford Macomb Hospital-Clinton Township

Recruiting

Clinton Township, Michigan, United States, 48038

Contacts

Site Public Contact

313-916-3721CTOResearch@hfhs.org

Principal Investigator:

Philip Kuriakose

Henry Ford Medical Center-Fairlane

Recruiting

Dearborn, Michigan, United States, 48126

Contacts

Site Public Contact

313-916-3721CTOResearch@hfhs.org

Principal Investigator:

Philip Kuriakose

Wayne State University/Karmanos Cancer Institute

Recruiting

Detroit, Michigan, United States, 48201

Contacts

Site Public Contact

313-576-9790ctoadmin@karmanos.org

Principal Investigator:

Andrew Kin

Henry Ford Hospital

Recruiting

Detroit, Michigan, United States, 48202

Contacts

Site Public Contact

313-916-3721CTOResearch@hfhs.org

Principal Investigator:

Philip Kuriakose

Weisberg Cancer Treatment Center

Recruiting

Farmington Hills, Michigan, United States, 48334

Contacts

Site Public Contact

313-576-9790ctoadmin@karmanos.org

Principal Investigator:

Andrew Kin

Allegiance Health

Recruiting

Jackson, Michigan, United States, 49201

Contacts

Site Public Contact

313-916-3721CTOResearch@hfhs.org

Principal Investigator:

Philip Kuriakose

Karmanos Cancer Institute at McLaren Greater Lansing

Recruiting

Lansing, Michigan, United States, 48910

Contacts

Site Public Contact

313-576-9790ctoadmin@karmanos.org

Principal Investigator:

Andrew Kin

Henry Ford Medical Center-Columbus

Recruiting

Novi, Michigan, United States, 48377

Contacts

Site Public Contact

313-916-3721CTOResearch@hfhs.org

Principal Investigator:

Philip Kuriakose

Henry Ford West Bloomfield Hospital

Recruiting

West Bloomfield, Michigan, United States, 48322

Contacts

Site Public Contact

313-916-3721CTOResearch@hfhs.org

Principal Investigator:

Philip Kuriakose

Henry Ford Wyandotte Hospital

Recruiting

Wyandotte, Michigan, United States, 48192

Contacts

Site Public Contact

nhay@hfhs.org

Principal Investigator:

Philip Kuriakose

Mercy Hospital

Recruiting

Coon Rapids, Minnesota, United States, 55433

Contacts

Site Public Contact

952-993-1517mmcorc@healthpartners.com

Principal Investigator:

David M. King

Fairview Southdale Hospital

Recruiting

Edina, Minnesota, United States, 55435

Contacts

Site Public Contact

952-993-1517mmcorc@healthpartners.com

Principal Investigator:

David M. King

Abbott-Northwestern Hospital

Recruiting

Minneapolis, Minnesota, United States, 55407

Contacts

Site Public Contact

952-993-1517mmcorc@healthpartners.com

Principal Investigator:

David M. King

Mayo Clinic in Rochester

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

Site Public Contact

855-776-0015

Principal Investigator:

Taxiarchis Kourelis

Park Nicollet Clinic - Saint Louis Park

Recruiting

Saint Louis Park, Minnesota, United States, 55416

Contacts

Site Public Contact

952-993-1517mmcorc@healthpartners.com

Principal Investigator:

David M. King

Regions Hospital

Recruiting

Saint Paul, Minnesota, United States, 55101

Contacts

Site Public Contact

952-993-1517mmcorc@healthpartners.com

Principal Investigator:

David M. King

United Hospital

Recruiting

Saint Paul, Minnesota, United States, 55102

Contacts

Site Public Contact

952-993-1517mmcorc@healthpartners.com

Principal Investigator:

David M. King

Baptist Memorial Hospital and Cancer Center-Oxford

Recruiting

Oxford, Mississippi, United States, 38655

Contacts

Site Public Contact

901-226-1366BCCclintrials@bmhcc.org

Principal Investigator:

Brion V. Randolph

Baptist Memorial Hospital and Cancer Center-Desoto

Recruiting

Southhaven, Mississippi, United States, 38671

Contacts

Site Public Contact

901-226-1366BCCclintrials@bmhcc.org

Principal Investigator:

Brion V. Randolph

Siteman Cancer Center at Saint Peters Hospital

Recruiting

City of Saint Peters, Missouri, United States, 63376

Contacts

Site Public Contact

800-600-3606info@siteman.wustl.edu

Principal Investigator:

Keith E. Stockerl-Goldstein

Siteman Cancer Center at West County Hospital

Recruiting

Creve Coeur, Missouri, United States, 63141

Contacts

Site Public Contact

800-600-3606info@siteman.wustl.edu

Principal Investigator:

Keith E. Stockerl-Goldstein

Washington University School of Medicine

Recruiting

St Louis, Missouri, United States, 63110

Contacts

Site Public Contact

800-600-3606info@siteman.wustl.edu

Principal Investigator:

Keith E. Stockerl-Goldstein

Siteman Cancer Center-South County

Recruiting

St Louis, Missouri, United States, 63129

Contacts

Site Public Contact

800-600-3606info@siteman.wustl.edu

Principal Investigator:

Keith E. Stockerl-Goldstein

Siteman Cancer Center at Christian Hospital

Recruiting

St Louis, Missouri, United States, 63136

Contacts

Site Public Contact

800-600-3606info@siteman.wustl.edu

Principal Investigator:

Keith E. Stockerl-Goldstein

Nebraska Medicine-Bellevue

Recruiting

Bellevue, Nebraska, United States, 68123

Contacts

Site Public Contact

402-559-6941unmcrsa@unmc.edu

Principal Investigator:

Sarah A. Holstein

Nebraska Medicine-Village Pointe

Recruiting

Omaha, Nebraska, United States, 68118

Contacts

Site Public Contact

402-559-5600

Principal Investigator:

Sarah A. Holstein

University of Nebraska Medical Center

Recruiting

Omaha, Nebraska, United States, 68198

Contacts

Site Public Contact

402-559-6941unmcrsa@unmc.edu

Principal Investigator:

Sarah A. Holstein

Memorial Sloan Kettering Monmouth

Recruiting

Middletown, New Jersey, United States, 07748

Contacts

Site Public Contact

212-639-7592

Principal Investigator:

Heather J. Landau

Memorial Sloan Kettering Bergen

Recruiting

Montvale, New Jersey, United States, 07645

Contacts

Site Public Contact

212-639-7592

Principal Investigator:

Heather J. Landau

Memorial Sloan Kettering Commack

Recruiting

Commack, New York, United States, 11725

Contacts

Site Public Contact

212-639-7592

Principal Investigator:

Heather J. Landau

Memorial Sloan Kettering Westchester

Recruiting

Harrison, New York, United States, 10604

Contacts

Site Public Contact

212-639-7592

Principal Investigator:

Heather J. Landau

NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center

Recruiting

New York, New York, United States, 10032

Contacts

Site Public Contact

212-342-5162cancerclinicaltrials@cumc.columbia.edu

Principal Investigator:

Rajshekhar Chakraborty

Memorial Sloan Kettering Cancer Center

Recruiting

New York, New York, United States, 10065

Contacts

Site Public Contact

212-639-7592

Principal Investigator:

Heather J. Landau

University of Rochester

Recruiting

Rochester, New York, United States, 14642

Contacts

Site Public Contact

585-275-5830

Principal Investigator:

Frank C. Passero

Novant Health Presbyterian Medical Center

Recruiting

Charlotte, North Carolina, United States, 28204

Contacts

Site Public Contact

980-201-6360kashah@novanthealth.org

Principal Investigator:

Raymond Thertulien

Duke University Medical Center

Recruiting

Durham, North Carolina, United States, 27710

Contacts

Site Public Contact

888-275-3853

Principal Investigator:

Cristiana C. Chase

Novant Health Cancer Institute - Huntersville

Recruiting

Huntersville, North Carolina, United States, 28078

Contacts

Site Public Contact

980-201-6360kashah@novanthealth.org

Principal Investigator:

Raymond Thertulien

Novant Health Cancer Institute - Mooresville

Recruiting

Mooresville, North Carolina, United States, 28117

Contacts

Site Public Contact

980-201-6360kashah@novanthealth.org

Principal Investigator:

Raymond Thertulien

Novant Health Forsyth Medical Center

Recruiting

Winston-Salem, North Carolina, United States, 27103

Contacts

Site Public Contact

336-718-8335pjordan@novanthealth.org

Principal Investigator:

Franklin L. Chen

Case Western Reserve University

Recruiting

Cleveland, Ohio, United States, 44106

Contacts

Site Public Contact

800-641-2422CTUReferral@UHhospitals.org

Principal Investigator:

Timothy E. O'brien

Riverside Methodist Hospital

Recruiting

Columbus, Ohio, United States, 43214

Contacts

Site Public Contact

614-788-3860Jennifer.Sexton@ohiohealth.com

Principal Investigator:

Yvonne A. Efebera

Providence Newberg Medical Center

Recruiting

Newberg, Oregon, United States, 97132

Contacts

Site Public Contact

503-215-2614CanRsrchStudies@providence.org

Principal Investigator:

Charles W. Drescher

Providence Willamette Falls Medical Center

Recruiting

Oregon City, Oregon, United States, 97045

Contacts

Site Public Contact

503-215-2614CanRsrchStudies@providence.org

Principal Investigator:

Charles W. Drescher

Providence Portland Medical Center

Recruiting

Portland, Oregon, United States, 97213

Contacts

Site Public Contact

503-215-2614CanRsrchStudies@providence.org

Principal Investigator:

Charles W. Drescher

Providence Saint Vincent Medical Center

Recruiting

Portland, Oregon, United States, 97225

Contacts

Site Public Contact

503-215-2614CanRsrchStudies@providence.org

Principal Investigator:

Charles W. Drescher

Geisinger Medical Center

Recruiting

Danville, Pennsylvania, United States, 17822

Contacts

Site Public Contact

570-271-5251HemonCCTrials@geisinger.edu

Principal Investigator:

Joseph P. Lynch

University of Pennsylvania/Abramson Cancer Center

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

Site Public Contact

215-349-8245PMCancerResearch@pennmedicine.upenn.edu

Principal Investigator:

Adam Waxman

Thomas Jefferson University Hospital

Recruiting

Philadelphia, Pennsylvania, United States, 19107

Contacts

Site Public Contact

215-600-9151ONCTrialNow@jefferson.edu

Principal Investigator:

Adam F. Binder

Geisinger Wyoming Valley/Henry Cancer Center

Recruiting

Wilkes-Barre, Pennsylvania, United States, 18711

Contacts

Site Public Contact

570-271-5251HemonCCTrials@geisinger.edu

Principal Investigator:

Joseph P. Lynch

Baptist Memorial Hospital and Cancer Center-Collierville

Recruiting

Collierville, Tennessee, United States, 38017

Contacts

Site Public Contact

901-226-1366BCCclintrials@bmhcc.org

Principal Investigator:

Brion V. Randolph

Baptist Memorial Hospital and Cancer Center-Memphis

Recruiting

Memphis, Tennessee, United States, 38120

Contacts

Site Public Contact

901-226-1366BCCclintrials@bmhcc.org

Principal Investigator:

Brion V. Randolph

Houston Methodist San Jacinto Hospital

Recruiting

Baytown, Texas, United States, 77521

Contacts

Site Public Contact

protocols@swog.org

Principal Investigator:

Carrie H. Yuen

Houston Methodist Cypress Hospital

Recruiting

Cypress, Texas, United States, 77429

Contacts

Site Public Contact

346-356-1413irb@houstonmethodist.org

Principal Investigator:

Carrie H. Yuen

Houston Methodist Hospital

Recruiting

Houston, Texas, United States, 77030

Contacts

Site Public Contact

713-790-2700

Principal Investigator:

Carrie H. Yuen

M D Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

Contacts

Site Public Contact

877-632-6789askmdanderson@mdanderson.org

Principal Investigator:

Jing Christine Ye

Methodist Willowbrook Hospital

Recruiting

Houston, Texas, United States, 77070

Contacts

Site Public Contact

protocols@swog.org

Principal Investigator:

Carrie H. Yuen

Houston Methodist West Hospital

Recruiting

Houston, Texas, United States, 77094

Contacts

Site Public Contact

832-522-2873

Principal Investigator:

Carrie H. Yuen

Houston Methodist Saint John Hospital

Recruiting

Nassau Bay, Texas, United States, 77058

Contacts

Site Public Contact

protocols@swog.org

Principal Investigator:

Carrie H. Yuen

Houston Methodist Sugar Land Hospital

Recruiting

Sugar Land, Texas, United States, 77479

Contacts

Site Public Contact

281-242-2873

Principal Investigator:

Carrie H. Yuen

Houston Methodist The Woodlands Hospital

Recruiting

The Woodlands, Texas, United States, 77385

Contacts

Site Public Contact

713-790-2700hmthewoodlands@houstonmethodist.org

Principal Investigator:

Carrie H. Yuen

Saint Vincent Hospital Cancer Center Green Bay

Recruiting

Green Bay, Wisconsin, United States, 54301

Contacts

Site Public Contact

920-433-8889WI_research_admin@hshs.org

Principal Investigator:

Matthew L. Ryan

Saint Vincent Hospital Cancer Center at Saint Mary's

Recruiting

Green Bay, Wisconsin, United States, 54303

Contacts

Site Public Contact

920-433-8889wi_research_admin@hshs.org

Principal Investigator:

Matthew L. Ryan

Gundersen Lutheran Medical Center

Recruiting

La Crosse, Wisconsin, United States, 54601

Contacts

Site Public Contact

608-775-2385cancerctr@gundersenhealth.org

Principal Investigator:

David E. Marinier

University of Wisconsin Carbone Cancer Center - Eastpark Medical Center

Recruiting

Madison, Wisconsin, United States, 53718

Contacts

Site Public Contact

800-622-8922clinicaltrials@cancer.wisc.edu

Principal Investigator:

Matthew J. Brunner

University of Wisconsin Carbone Cancer Center - University Hospital

Recruiting

Madison, Wisconsin, United States, 53792

Contacts

Site Public Contact

800-622-8922clinicaltrials@cancer.wisc.edu

Principal Investigator:

Matthew J. Brunner

Medical College of Wisconsin

Recruiting

Milwaukee, Wisconsin, United States, 53226

Contacts

Site Public Contact

414-805-3666

Principal Investigator:

Anita D'Souza

Saint Vincent Hospital Cancer Center at Oconto Falls

Recruiting

Oconto Falls, Wisconsin, United States, 54154

Contacts

Site Public Contact

920-433-8889WI_research_admin@hshs.org

Principal Investigator:

Matthew L. Ryan

Saint Vincent Hospital Cancer Center at Sheboygan

Recruiting

Sheboygan, Wisconsin, United States, 53081

Contacts

Site Public Contact

920-433-8889wi_research_admin@hshs.org

Principal Investigator:

Matthew L. Ryan

Sheboygan Physicians Group

Recruiting

Sheboygan, Wisconsin, United States, 53081

Contacts

Site Public Contact

920-433-8889wi_research_admin@hshs.org

Principal Investigator:

Matthew L. Ryan

Saint Vincent Hospital Cancer Center at Sturgeon Bay

Recruiting

Sturgeon Bay, Wisconsin, United States, 54235-1495

Contacts

Site Public Contact

920-433-8889wi_research_admin@hshs.org

Principal Investigator:

Matthew L. Ryan

More Information

Sponsor

SWOG Cancer Research Network

Last update posted

May 6, 2026

Last verified

Sep, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by SWOG Cancer Research Network on 2026-05-06.