This trial is no longer recruiting

Recruitment for this study has ended, so applications are closed. You can still read the trial details, or browse similar trials that are currently recruiting.

Not recruiting
Phase 3

Steroids & TKIs

Sponsor:

National Cancer Institute (NCI)

Code:

NCT04530565

Conditions

B Acute Lymphoblastic Leukemia With t(9;22)(q34.1;q11.2); BCR-ABL1

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Biospecimen Collection

Blinatumomab

Bone Marrow Aspiration and Biopsy

Cyclophosphamide

Cytarabine

Study Details

Brief summary:

This phase III trial compares the effect of usual treatment of chemotherapy and steroids and a tyrosine kinase inhibitor (TKI) to the same treatment plus blinatumomab. Blinatumomab is a Bi-specific T-Cell Engager ('BiTE') that may interfere with the ability of cancer cells to grow and spread. The information gained from this study may help researchers determine if combination therapy with steroids, TKIs, and blinatumomab work better than the standard of care.

Conditions

B Acute Lymphoblastic Leukemia With t(9;22)(q34.1;q11.2); BCR-ABL1

Study ID

NCT04530565

Start date

Jan 25, 2021

Status verified date

Feb, 2026

Completion date

Jul 1, 2028

Anticipated

Primary completion date

Jul 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • ELIGIBILITY CRITERIA FOR PRE-REGISTRATION (TO STEP 0)
  • Patient must be >= 18 and =< 75 years of age
  • Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status between 0-3
  • Patient must be newly diagnosed with B acute lymphoblastic leukemia (B-ALL) or is suspected to have acute lymphoblastic leukemia (ALL)

  • Patient must have BCR-ABL1 positive disease. The diagnosis of ALL and the presence of BCR-ABL translocation must be confirmed centrally. Patients can be registered and begin step 1 therapy while awaiting central laboratory eligibility confirmation

  • NOTE: Bone marrow aspirate and/or peripheral blood specimen must be submitted to the ECOG-American College of Radiology Imaging Network (ACRIN) Leukemia Laboratory at MD Anderson Cancer Center to determine patient's eligibility for registration to Step 1 or confirm patient evaluability. Centrally fluorescence-activated cell sorting (FACS) analysis will be performed to determine B-ALL and to exclude acute myeloid leukemia (AML) or acute bi-phenotypic leukemia and baseline BCR-ABL status will be determined by fluorescent in situ hybridization (FISH). The ECOG-ACRIN Leukemia Laboratory will forward results within 48 hours of receipt of the specimen to the submitting institution. Bone marrow aspirate is to be from first pull (initial or re-direct). Specimens must contain sufficient blast cells. In cases where the bone marrow aspiration may be inadequate, or the bone marrow examination has already been performed prior to study consent and enrollment on Step 0, peripheral blood may be submitted, with recommendation that adequate circulating blasts are present (> 10%). If a diagnosis of BCR-ABL positive B-ALL has already been established by local Clinical Laboratory Improvement Act (CLIA) certified laboratories, the patient may be registered to step 1 without waiting for central confirmation
  • Patient must not have a diagnosis of BCR/ABL T-ALL
  • Patient must not have received chemotherapy for B-ALL. Patients who received up to five days of therapy (hydroxyurea and/or steroids of any kind) with the aim to reduce disease burden prior to study registration to Step 1 are eligible
  • Patient must not have unstable epilepsy that requires treatment
  • Patients with lymphoid blast crisis chronic myeloid leukemia (CML) are not eligible
  • ELIGIBILITY CRITERIA FOR REGISTRATION TO STEP 1
  • Patient must have a diagnosis of Philadelphia chromosome positive (Ph+) ALL that has been determined locally and bone marrow and/or peripheral blood was sent and receipt confirmed for central confirmation or determined centrally by the ECOG-ACRIN Leukemia Laboratory at MD Anderson Cancer Center
  • Patient must not be pregnant or breast-feeding due to the potential harm to an unborn fetus and possible risk for adverse events in nursing infants with the treatment regimens being used. All patients of childbearing potential must have a blood test or urine study within 14 days prior to registration to rule out pregnancy. A patient of childbearing potential is defined as any woman, regardless of whether they have undergone tubal ligation, who meets the following criteria: 1) has achieved menarche at some point, 2) has not undergone a hysterectomy or bilateral oophorectomy, or 3) has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months)
  • Patients must not expect to conceive or father children by using accepted and effective method(s) of contraception or by abstaining from sexual intercourse from the time of step 1 registration, while on study treatment, and until at least six months after the last dose of study treatment
  • Total bilirubin =< 3 mg/dL (patients with Gilbert's syndrome must have a total bilirubin =< 5 mg/dL) (obtained =< 28 days prior to step 1 registration)
  • Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase \[SGOT\]) and alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \[SGPT\]) =< 2.5 X the institutional upper limit of normal (ULN) (obtained =< 28 days prior to step 1 registration)
  • Estimated creatinine clearance > 45 mL/min (based on Cockcroft-Gault equation) (obtained =< 28 days prior to step 1 registration)
  • Patients with acute organ dysfunction at step 1 registration, which may be attributed to leukemia can be registered regardless of lab results at presentation. Such patients will be allowed to register and can start Arm A steroid + TKI therapy but will only be allowed to proceed to step 2 randomization if the eligibility criteria outlined is met
  • Patients who presented with no evidence of acute organ dysfunction but during step 0 experienced a rise in liver enzymes which investigator suspects to be a side effect of any of prescribed drugs, are allowed to be registered regardless of the level of liver enzymes. Step 2 randomization must be withheld until the eligibility criteria outline is met but no more than 14 days after concluding Arm A therapy
  • Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial
  • For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable or on suppressive therapy, if indicated
  • Patients with a history of hepatitis C virus (HCV) infection must have an undetectable HCV viral load and if indicated, on treatment
  • Patients with a prior malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial
  • Patient must not have active concomitant malignancy. Patients on chronic hormonal therapy for breast or prostate cancer or patients treated with maintenance with targeted agents but are in remission with no evidence for the primary malignancies are eligible
  • Patient must not have complaints of symptoms and/or have clinical and/or radiological signs that indicate an uncontrolled infection or any other concurrent medical condition that could be exacerbated by the treatment or would seriously complicate compliance with the protocol
  • Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients must be class 2B or better
  • Investigators must confirm which TKI patient is to receive

  • NOTE: Patients with known T315I mutation status should receive ponatinib treatment
  • NOTE: In situations due to insurance coverage issues and the pre-selected TKI is not immediately available, patients can receive dasatinib or imatinib during step 1. The investigator must re-specify dasatinib or ponatinib prior to step 2 randomization and from then on patients must receive the pre-selected TKI only
  • ELIGIBILITY CRITERIA FOR RANDOMIZATION TO STEP 2
  • Patient must have completed at least 7 and no more than 21 days of protocol-treatment on Arm A prior to step 2 randomization. (Days in which arm A therapy was withheld for any reason are not counted)

  • NOTE: First day of steroids prescription after registration will be considered as the first day of study therapy. The selected TKI must be initiated prior to randomization
  • Patients who presented with acute organ dysfunction within 2 weeks of registration to step 1 must have total bilirubin =< 2 X institutional upper limit of normal (ULN)
  • AST(SGOT) and ALT(SGPT) =< 2 X the institutional upper limit of normal (ULN)
  • Estimated creatinine clearance > 45 mL/min (based on Cockcroft-Gault equation)
  • Investigators must confirm which TKI patient is to receive.

  • NOTE: Patients with known T315I mutation status should receive ponatinib treatment
  • For patients under age 70, intended chemotherapy regimen must have been determined prior to randomization
  • Patient must not have active central nervous system (CNS) involvement by leukemic blasts. Patients with signs of CNS involvement at presentation are eligible for randomization if clearance of blasts from the cerebrospinal fluid (CSF) is demonstrated
  • Patients must have resolved any serious infectious complications related to therapy
  • Any significant medical complications related to therapy must have resolved
  • ELIGIBILITY CRITERIA FOR REGISTRATION TO STEP 3 (RE-INDUCTION)
  • Institution has received centralized MRD results confirming positive status
  • Patients who presented with acute organ dysfunction within 2 weeks of registration to step 1 must have total bilirubin =< 2 X institutional ULN
  • Patients who presented with acute organ dysfunction must have AST (SGOT)/ALT (SGPT) =< 2 X institutional upper limit of normal (ULN)
  • Patients who presented with acute organ dysfunction must have an estimated creatinine clearance > 45 mL/min (based on Cockcroft-Gault equation)
  • Investigators must confirm which TKI patient is to receive

  • NOTE: Patients with known T315I mutation status should receive ponatinib treatment
  • For patients under age 70 and previously assigned to Arm C, intended chemotherapy regimen must have been determined
  • Step 3 (Re-Induction): Patients must have resolved any serious infectious complications related to therapy
  • Step 3 (Re-Induction): Any significant medical complications related to therapy must have resolved

Study Design

Enrollment

348 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Arm A (steroid, TKI), Single Arm Pre-Induction

Patients receive prednisone PO QD on days 1-21 and ponatinib PO QD or dasatinib PO QD on days 1-21 based on investigator's choice.

experimental: Arm B (steroid, TKI, chemotherapy)

See Detailed Description.

experimental: Arm C (steroid, TKI, chemotherapy, immunotherapy)

CYCLE 1: Patients receive ponatinib PO QD or dasatinib PO QD on days 1-28. Patients also receive dexamethasone PO or IV on day 1 and blinatumomab IV continuously on days 1-28, followed by methotrexate IT on day 29 or 30.

CYCLE 2: Patients receive ponatinib PO QD or dasatinib PO QD on days 1-28. Patients also receive dexamethasone PO or IV on day 1 and blinatumomab IV continuously on days 1-28.

Treatment repeats every 28 days for up to 2 cycles in the absence of disease progression or unacceptable toxicity.

experimental: Arm D (steroid, TKI, chemotherapy, immunotherapy)

Patients treated on Arm B who remain MRD positive at the end of induction therapy receive blinatumomab based re-induction identical to the regimen described for Arm C.

Patients whose molecular test remains MRD positive after re-induction proceed to follow-up at the discretion of the investigator or receive anti CD-19 CAR- T cell therapy, inotuzumab ozogamicin, intensive chemotherapy, or palliative care.

experimental: Arm E (steroid, TKI, chemotherapy)

Patients treated on Arm C who remain MRD positive at the end of induction therapy receive chemotherapy based re-induction which is identical to regimen described for Arm B according to patient's age and the pre-specified chemotherapy arm.

Patients whose molecular test remains MRD positive after re-induction proceed to follow-up at the discretion of the investigator or receive anti CD-19 CAR- T cell therapy, inotuzumab ozogamicin, intensive chemotherapy, or palliative care.

Interventions

Biospecimen Collection

Correlative studies

Blinatumomab

Given IV

Bone Marrow Aspiration and Biopsy

Undergo bone marrow aspiration and biopsy

Cyclophosphamide

Given IV

Cytarabine

Given IV or IT

Dasatinib

Given PO

Dexamethasone

Given PO or IV

Doxorubicin Hydrochloride

Given IV

Echocardiography Test

Undergo ECHO

Electrocardiography

Undergo ECG

Lumbar Puncture

Undergo lumbar puncture

Mesna

Given IV

Methotrexate

Given IV or IT

Multigated Acquisition Scan

Undergo MUGA

Ponatinib Hydrochloride

Given PO

Prednisone

Given PO

Vincristine Sulfate

Given IV

Primary outcome measure

  • Overall survival (OS) [ Time Frame: Time between randomization and death from any cause, assessed up to 10 years from the date of registration ]

Central Contacts and Locations

Locations

University of Alabama at Birmingham Cancer Center

Recruiting

Birmingham, Alabama, United States, 35233

Contacts

Site Public Contact

gingerreeves@uabmc.edu

Principal Investigator:

Sravanti Rangaraju

Community Cancer Institute

Recruiting

Clovis, California, United States, 93611

Contacts

Site Public Contact

559-387-1827

Principal Investigator:

Haifaa Abdulhaq

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:

Deepa Jeyakumar

UC San Diego Moores Cancer Center

Recruiting

La Jolla, California, United States, 92093

Contacts

Site Public Contact

858-822-5354cancercto@ucsd.edu

Principal Investigator:

James K. Mangan

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:

Deepa Jeyakumar

Yale University

Recruiting

New Haven, Connecticut, United States, 06520

Contacts

Site Public Contact

203-785-5702canceranswers@yale.edu

Principal Investigator:

Lourdes M. Mendez

Augusta University Medical Center

Recruiting

Augusta, Georgia, United States, 30912

Contacts

Site Public Contact

706-721-2388ga_cares@augusta.edu

Principal Investigator:

Vamsi Kota

Straub Clinic and Hospital

Recruiting

Honolulu, Hawaii, United States, 96813

Contacts

Site Public Contact

808-522-4333

Principal Investigator:

Craig S. Boddy

Kapiolani Medical Center for Women and Children

Recruiting

Honolulu, Hawaii, United States, 96826

Contacts

Site Public Contact

808-983-6090

Principal Investigator:

Craig S. Boddy

Hawaii Cancer Care - Westridge

Recruiting

‘Aiea, Hawaii, United States, 96701

Contacts

Site Public Contact

808-539-2273info@hawaiicancercare.com

Principal Investigator:

Craig S. Boddy

Pali Momi Medical Center

Recruiting

‘Aiea, Hawaii, United States, 96701

Contacts

Site Public Contact

808-486-6000

Principal Investigator:

Craig S. Boddy

Saint Alphonsus Cancer Care Center-Nampa

Recruiting

Nampa, Idaho, United States, 83687

Contacts

Site Public Contact

406-969-6060mccinfo@mtcancer.org

Principal Investigator:

Elie G. Dib

Northwestern University

Recruiting

Chicago, Illinois, United States, 60611

Contacts

Site Public Contact

312-695-1301cancer@northwestern.edu

Principal Investigator:

Shira N. Dinner

Loyola University Medical Center

Recruiting

Maywood, Illinois, United States, 60153

Contacts

Site Public Contact

708-226-4357

Principal Investigator:

Stephanie B. Tsai

Indiana University/Melvin and Bren Simon Cancer Center

Recruiting

Indianapolis, Indiana, United States, 46202

Contacts

Site Public Contact

317-278-5632iutrials@iu.edu

Principal Investigator:

Rita Assi

Mary Greeley Medical Center

Recruiting

Ames, Iowa, United States, 50010

Contacts

Site Public Contact

515-956-4132

Principal Investigator:

Joseph J. Merchant

McFarland Clinic - Ames

Recruiting

Ames, Iowa, United States, 50010

Contacts

Site Public Contact

515-239-4734ksoder@mcfarlandclinic.com

Principal Investigator:

Joseph J. Merchant

McFarland Clinic - Trinity Cancer Center

Recruiting

Fort Dodge, Iowa, United States, 50501

Contacts

Site Public Contact

515-956-4132

Principal Investigator:

Joseph J. Merchant

McFarland Clinic - Marshalltown

Recruiting

Marshalltown, Iowa, United States, 50158

Contacts

Site Public Contact

515-956-4132

Principal Investigator:

Joseph J. Merchant

University of Kansas Cancer Center

Recruiting

Kansas City, Kansas, United States, 66160

Contacts

Site Public Contact

913-588-3671KUCC_Navigation@kumc.edu

Principal Investigator:

Kenneth Byrd

University of Kansas Hospital-Indian Creek Campus

Recruiting

Overland Park, Kansas, United States, 66211

Contacts

Site Public Contact

913-588-3671KUCC_Navigation@kumc.edu

Principal Investigator:

Kenneth Byrd

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:

Kenneth Byrd

The James Graham Brown Cancer Center at University of Louisville

Recruiting

Louisville, Kentucky, United States, 40202

Contacts

Site Public Contact

502-562-3429

Principal Investigator:

Mohamed M. Hegazi

UofL Health Medical Center Northeast

Recruiting

Louisville, Kentucky, United States, 40245

Contacts

Site Public Contact

502-852-2755ctoinfo@louisville.edu

Principal Investigator:

Mohamed M. Hegazi

Johns Hopkins University/Sidney Kimmel Cancer Center

Recruiting

Baltimore, Maryland, United States, 21287

Contacts

Site Public Contact

410-955-8804jhcccro@jhmi.edu

Principal Investigator:

Jonathan A. Webster

Walter Reed National Military Medical Center

Recruiting

Bethesda, Maryland, United States, 20889-5600

Contacts

Site Public Contact

301-319-2100

Principal Investigator:

Christin Destefano

Trinity Health Saint Joseph Mercy Hospital Ann Arbor

Recruiting

Ann Arbor, Michigan, United States, 48106

Contacts

Site Public Contact

734-712-7251MCRCwebsitecontactform@stjoeshealth.org

Principal Investigator:

Elie G. Dib

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:

Dale Bixby

Trinity Health IHA Medical Group Hematology Oncology - Brighton

Recruiting

Brighton, Michigan, United States, 48114

Contacts

Site Public Contact

734-712-7251MCRCwebsitecontactform@stjoeshealth.org

Principal Investigator:

Elie G. Dib

Trinity Health Medical Center - Brighton

Recruiting

Brighton, Michigan, United States, 48114

Contacts

Site Public Contact

734-712-7251MCRCwebsitecontactform@stjoeshealth.org

Principal Investigator:

Elie G. Dib

Henry Ford Cancer Institute-Downriver

Recruiting

Brownstown, Michigan, United States, 48183

Contacts

Site Public Contact

313-916-3721CTOResearch@hfhs.org

Principal Investigator:

Haythem Y. Ali

Trinity Health IHA Medical Group Hematology Oncology - Canton

Recruiting

Canton, Michigan, United States, 48188

Contacts

Site Public Contact

734-712-7251MCRCwebsitecontactform@stjoeshealth.org

Principal Investigator:

Elie G. Dib

Trinity Health Medical Center - Canton

Recruiting

Canton, Michigan, United States, 48188

Contacts

Site Public Contact

734-712-7251MCRCwebsitecontactform@stjoeshealth.org

Principal Investigator:

Elie G. Dib

Chelsea Hospital

Recruiting

Chelsea, Michigan, United States, 48118

Contacts

Site Public Contact

734-712-7251MCRCwebsitecontactform@stjoeshealth.org

Principal Investigator:

Elie G. Dib

Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital

Recruiting

Chelsea, Michigan, United States, 48118

Contacts

Site Public Contact

734-712-7251MCRCwebsitecontactform@stjoeshealth.org

Principal Investigator:

Elie G. Dib

Hematology Oncology Consultants-Clarkston

Recruiting

Clarkston, Michigan, United States, 48346

Contacts

Site Public Contact

734-712-7251MCRCwebsitecontactform@stjoeshealth.org

Principal Investigator:

Elie G. Dib

Newland Medical Associates-Clarkston

Recruiting

Clarkston, Michigan, United States, 48346

Contacts

Site Public Contact

734-712-7251MCRCwebsitecontactform@stjoeshealth.org

Principal Investigator:

Elie G. Dib

Henry Ford Macomb Hospital-Clinton Township

Recruiting

Clinton Township, Michigan, United States, 48038

Contacts

Site Public Contact

313-916-3721CTOResearch@hfhs.org

Principal Investigator:

Haythem Y. Ali

Henry Ford Medical Center-Fairlane

Recruiting

Dearborn, Michigan, United States, 48126

Contacts

Site Public Contact

313-916-3721CTOResearch@hfhs.org

Principal Investigator:

Haythem Y. Ali

Wayne State University/Karmanos Cancer Institute

Recruiting

Detroit, Michigan, United States, 48201

Contacts

Site Public Contact

313-576-9790ctoadmin@karmanos.org

Principal Investigator:

Jay Yang

Henry Ford Hospital

Recruiting

Detroit, Michigan, United States, 48202

Contacts

Site Public Contact

313-916-3721CTOResearch@hfhs.org

Principal Investigator:

Haythem Y. Ali

Cancer Hematology Centers - Flint

Recruiting

Flint, Michigan, United States, 48503

Contacts

Site Public Contact

810-762-8038wstrong@ghci.org

Principal Investigator:

Elie G. Dib

Genesys Hurley Cancer Institute

Recruiting

Flint, Michigan, United States, 48503

Contacts

Site Public Contact

810-762-8038wstrong@ghci.org

Principal Investigator:

Elie G. Dib

Hurley Medical Center

Recruiting

Flint, Michigan, United States, 48503

Contacts

Site Public Contact

810-762-8038wstrong@ghci.org

Principal Investigator:

Elie G. Dib

Allegiance Health

Recruiting

Jackson, Michigan, United States, 49201

Contacts

Site Public Contact

313-916-3721CTOResearch@hfhs.org

Principal Investigator:

Haythem Y. Ali

Trinity Health Saint Mary Mercy Livonia Hospital

Recruiting

Livonia, Michigan, United States, 48154

Contacts

Site Public Contact

734-712-7251MCRCwebsitecontactform@stjoeshealth.org

Principal Investigator:

Elie G. Dib

Henry Ford Saint John Hospital - Macomb Medical

Recruiting

Macomb, Michigan, United States, 48044

Contacts

Site Public Contact

313-343-3166kforman1@hfhs.org

Principal Investigator:

Elie G. Dib

Henry Ford Medical Center-Columbus

Recruiting

Novi, Michigan, United States, 48377

Contacts

Site Public Contact

313-916-3721CTOResearch@hfhs.org

Principal Investigator:

Haythem Y. Ali

Michigan Healthcare Professionals Pontiac

Recruiting

Pontiac, Michigan, United States, 48341

Contacts

Site Public Contact

248-858-6215Emily.Crofts@trinity-health.org

Principal Investigator:

Elie G. Dib

Newland Medical Associates-Pontiac

Recruiting

Pontiac, Michigan, United States, 48341

Contacts

Site Public Contact

734-712-7251MCRCwebsitecontactform@stjoeshealth.org

Principal Investigator:

Elie G. Dib

Trinity Health Saint Joseph Mercy Oakland Hospital

Recruiting

Pontiac, Michigan, United States, 48341

Contacts

Site Public Contact

734-712-7251MCRCwebsitecontactform@stjoeshealth.org

Principal Investigator:

Elie G. Dib

MyMichigan Medical Center Saginaw

Recruiting

Saginaw, Michigan, United States, 48601

Contacts

Site Public Contact

734-712-7251MCRCwebsitecontactform@stjoeshealth.org

Principal Investigator:

Elie G. Dib

MyMichigan Medical Center Tawas

Recruiting

Tawas City, Michigan, United States, 48764

Contacts

Site Public Contact

734-712-7251MCRCwebsitecontactform@stjoeshealth.org

Principal Investigator:

Elie G. Dib

Henry Ford West Bloomfield Hospital

Recruiting

West Bloomfield, Michigan, United States, 48322

Contacts

Site Public Contact

313-916-3721CTOResearch@hfhs.org

Principal Investigator:

Haythem Y. Ali

Henry Ford Wyandotte Hospital

Recruiting

Wyandotte, Michigan, United States, 48192

Contacts

Site Public Contact

nhay@hfhs.org

Principal Investigator:

Haythem Y. Ali

Huron Gastroenterology PC

Recruiting

Ypsilanti, Michigan, United States, 48106

Contacts

Site Public Contact

734-712-7251MCRCwebsitecontactform@stjoeshealth.org

Principal Investigator:

Elie G. Dib

Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus

Recruiting

Ypsilanti, Michigan, United States, 48197

Contacts

Site Public Contact

734-712-7251MCRCwebsitecontactform@stjoeshealth.org

Principal Investigator:

Elie G. Dib

Mayo Clinic in Rochester

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

Site Public Contact

855-776-0015

Principal Investigator:

Antoine Saliba

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:

Geoffrey L. Uy

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:

Geoffrey L. Uy

Freeman Health System

Recruiting

Joplin, Missouri, United States, 64804

Contacts

Site Public Contact

417-347-4030LJCrockett@freemanhealth.com

Principal Investigator:

Jay W. Carlson

Washington University School of Medicine

Recruiting

St Louis, Missouri, United States, 63110

Contacts

Site Public Contact

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

Principal Investigator:

Geoffrey L. Uy

Mercy Hospital South

Recruiting

St Louis, Missouri, United States, 63128

Contacts

Site Public Contact

314-525-6042Danielle.Werle@mercy.net

Principal Investigator:

Jay W. Carlson

Siteman Cancer Center-South County

Recruiting

St Louis, Missouri, United States, 63129

Contacts

Site Public Contact

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

Principal Investigator:

Geoffrey L. Uy

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:

Geoffrey L. Uy

Mercy Hospital Saint Louis

Recruiting

St Louis, Missouri, United States, 63141

Contacts

Site Public Contact

314-251-7066

Principal Investigator:

Jay W. Carlson

Monmouth Medical Center

Recruiting

Long Branch, New Jersey, United States, 07740

Contacts

Site Public Contact

732-923-6564mary.danish@rwjbh.org

Principal Investigator:

Neil D. Palmisiano

Rutgers Cancer Institute of New Jersey

Recruiting

New Brunswick, New Jersey, United States, 08903

Contacts

Site Public Contact

732-235-7356

Principal Investigator:

Neil D. Palmisiano

University of New Mexico Cancer Center

Recruiting

Albuquerque, New Mexico, United States, 87106

Contacts

Site Public Contact

505-925-0348HSC-ClinicalTrialInfo@salud.unm.edu

Principal Investigator:

Charles Foucar

University of Rochester

Recruiting

Rochester, New York, United States, 14642

Contacts

Site Public Contact

585-275-5830

Principal Investigator:

Paul M. Barr

Montefiore Medical Center-Einstein Campus

Recruiting

The Bronx, New York, United States, 10461

Contacts

Site Public Contact

718-379-6866eskwak@montefiore.org

Principal Investigator:

Ioannis Mantzaris

Montefiore Medical Center - Moses Campus

Recruiting

The Bronx, New York, United States, 10467

Contacts

Site Public Contact

718-379-6866eskwak@montefiore.org

Principal Investigator:

Ioannis Mantzaris

UNC Lineberger Comprehensive Cancer Center

Recruiting

Chapel Hill, North Carolina, United States, 27599

Contacts

Site Public Contact

877-668-0683cancerclinicaltrials@med.unc.edu

Principal Investigator:

Katarzyna J. Jamieson

Duke University Medical Center

Recruiting

Durham, North Carolina, United States, 27710

Contacts

Site Public Contact

888-275-3853

Principal Investigator:

Harry P. Erba

Wake Forest University Health Sciences

Recruiting

Winston-Salem, North Carolina, United States, 27157

Contacts

Site Public Contact

336-713-6771

Principal Investigator:

Bayard L. Powell

University of Cincinnati Cancer Center-UC Medical Center

Recruiting

Cincinnati, Ohio, United States, 45219

Contacts

Site Public Contact

513-584-7698cancer@uchealth.com

Principal Investigator:

Emily K. Curran

Case Western Reserve University

Recruiting

Cleveland, Ohio, United States, 44106

Contacts

Site Public Contact

800-641-2422CTUReferral@UHhospitals.org

Principal Investigator:

Rebecca B. Klisovic

Ohio State University Comprehensive Cancer Center

Recruiting

Columbus, Ohio, United States, 43210

Contacts

Site Public Contact

800-293-5066Jamesline@osumc.edu

Principal Investigator:

Meixiao Long

University of Cincinnati Cancer Center-West Chester

Recruiting

West Chester, Ohio, United States, 45069

Contacts

Site Public Contact

513-584-7698cancer@uchealth.com

Principal Investigator:

Emily K. Curran

University of Oklahoma Health Sciences Center

Recruiting

Oklahoma City, Oklahoma, United States, 73104

Contacts

Site Public Contact

405-271-8777ou-clinical-trials@ouhsc.edu

Principal Investigator:

Mohamad Khawandanah

Providence Newberg Medical Center

Recruiting

Newberg, Oregon, United States, 97132

Contacts

Site Public Contact

503-215-2614CanRsrchStudies@providence.org

Principal Investigator:

Alison K. Conlin

Providence Willamette Falls Medical Center

Recruiting

Oregon City, Oregon, United States, 97045

Contacts

Site Public Contact

503-215-2614CanRsrchStudies@providence.org

Principal Investigator:

Alison K. Conlin

Providence Portland Medical Center

Recruiting

Portland, Oregon, United States, 97213

Contacts

Site Public Contact

503-215-2614CanRsrchStudies@providence.org

Principal Investigator:

Alison K. Conlin

Providence Saint Vincent Medical Center

Recruiting

Portland, Oregon, United States, 97225

Contacts

Site Public Contact

503-215-2614CanRsrchStudies@providence.org

Principal Investigator:

Alison K. Conlin

Lehigh Valley Hospital-Cedar Crest

Recruiting

Allentown, Pennsylvania, United States, 18103

Contacts

Site Public Contact

610-402-9543Morgan_M.Horton@lvhn.org

Principal Investigator:

Elie G. Dib

Lehigh Valley Hospital - Muhlenberg

Recruiting

Bethlehem, Pennsylvania, United States, 18017

Contacts

Site Public Contact

610-402-9543Morgan_M.Horton@lvhn.org

Principal Investigator:

Elie G. Dib

Geisinger Medical Center

Recruiting

Danville, Pennsylvania, United States, 17822

Contacts

Site Public Contact

570-271-5251HemonCCTrials@geisinger.edu

Principal Investigator:

Joseph J. Vadakara

Pocono Medical Center

Recruiting

East Stroudsburg, Pennsylvania, United States, 18301

Contacts

Site Public Contact

610-402-9543Morgan_M.Horton@lvhn.org

Principal Investigator:

Elie G. Dib

Lehigh Valley Hospital-Hazleton

Recruiting

Hazleton, Pennsylvania, United States, 18201

Contacts

Site Public Contact

610-402-9543Morgan_M.Horton@lvhn.org

Principal Investigator:

Elie G. Dib

University of Pennsylvania/Abramson Cancer Center

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

Site Public Contact

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

Principal Investigator:

Keith W. Pratz

Thomas Jefferson University Hospital

Recruiting

Philadelphia, Pennsylvania, United States, 19107

Contacts

Site Public Contact

215-600-9151ONCTrialNow@jefferson.edu

Principal Investigator:

Lindsay Wilde

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 J. Vadakara

Prisma Health Cancer Institute - Spartanburg

Recruiting

Boiling Springs, South Carolina, United States, 29316

Contacts

Site Public Contact

864-522-4317Kim.Williams3@prismahealth.org

Principal Investigator:

Suzanne R. Fanning

Medical University of South Carolina

Recruiting

Charleston, South Carolina, United States, 29425

Contacts

Site Public Contact

843-792-9321hcc-clinical-trials@musc.edu

Principal Investigator:

Praneeth Baratam

Prisma Health Cancer Institute - Easley

Recruiting

Easley, South Carolina, United States, 29640

Contacts

Site Public Contact

864-522-4317Kim.Williams3@prismahealth.org

Principal Investigator:

Suzanne R. Fanning

Prisma Health Cancer Institute - Butternut

Recruiting

Greenville, South Carolina, United States, 29605

Contacts

Site Public Contact

864-522-4317Kim.Williams3@prismahealth.org

Principal Investigator:

Suzanne R. Fanning

Prisma Health Cancer Institute - Faris

Recruiting

Greenville, South Carolina, United States, 29605

Contacts

Site Public Contact

864-522-4317Kim.Williams3@prismahealth.org

Principal Investigator:

Suzanne R. Fanning

Prisma Health Greenville Memorial Hospital

Recruiting

Greenville, South Carolina, United States, 29605

Contacts

Site Public Contact

864-522-4317Kim.Williams3@prismahealth.org

Principal Investigator:

Suzanne R. Fanning

Prisma Health Cancer Institute - Eastside

Recruiting

Greenville, South Carolina, United States, 29615

Contacts

Site Public Contact

864-522-4317Kim.Williams3@prismahealth.org

Principal Investigator:

Suzanne R. Fanning

Prisma Health Cancer Institute - Greer

Recruiting

Greer, South Carolina, United States, 29650

Contacts

Site Public Contact

864-522-4317Kim.Williams3@prismahealth.org

Principal Investigator:

Suzanne R. Fanning

Prisma Health Cancer Institute - Seneca

Recruiting

Seneca, South Carolina, United States, 29672

Contacts

Site Public Contact

864-522-4317Kim.Williams3@prismahealth.org

Principal Investigator:

Suzanne R. Fanning

Baptist Memorial Hospital and Cancer Center-Memphis

Recruiting

Memphis, Tennessee, United States, 38120

Contacts

Site Public Contact

901-226-1366BCCclintrials@bmhcc.org

Principal Investigator:

Salil Goorha

Vanderbilt University/Ingram Cancer Center

Recruiting

Nashville, Tennessee, United States, 37232

Contacts

Site Public Contact

800-811-8480

Principal Investigator:

Sanjay R. Mohan

UT Southwestern/Simmons Cancer Center-Dallas

Recruiting

Dallas, Texas, United States, 75390

Contacts

Site Public Contact

214-648-7097canceranswerline@UTSouthwestern.edu

Principal Investigator:

Yazan Madanat

Houston Methodist Hospital

Recruiting

Houston, Texas, United States, 77030

Contacts

Site Public Contact

713-790-2700

Principal Investigator:

Shilpan Shah

Huntsman Cancer Institute/University of Utah

Recruiting

Salt Lake City, Utah, United States, 84112

Contacts

Site Public Contact

888-424-2100cancerinfo@hci.utah.edu

Principal Investigator:

Srinivas K. Tantravahi

University of Vermont Medical Center

Recruiting

Burlington, Vermont, United States, 05401

Contacts

Site Public Contact

802-656-4101rpo@uvm.edu

Principal Investigator:

Diego A. Adrianzen Herrera

University of Vermont and State Agricultural College

Recruiting

Burlington, Vermont, United States, 05405

Contacts

Site Public Contact

802-656-8990rpo@uvm.edu

Principal Investigator:

Diego A. Adrianzen Herrera

VCU Massey Comprehensive Cancer Center

Recruiting

Richmond, Virginia, United States, 23298

Contacts

Site Public Contact

804-628-6430CTOclinops@vcu.edu

Principal Investigator:

Keri R. Maher

Kadlec Clinic Hematology and Oncology

Recruiting

Kennewick, Washington, United States, 99336

Contacts

Site Public Contact

509-783-4637research@kadlecmed.org

Principal Investigator:

Alison K. Conlin

Marshfield Medical Center-EC Cancer Center

Recruiting

Eau Claire, Wisconsin, United States, 54701

Contacts

Site Public Contact

800-782-8581oncology.clinical.trials@marshfieldresearch.org

Principal Investigator:

Kareem H. Abdelhadi

Gundersen Lutheran Medical Center

Recruiting

La Crosse, Wisconsin, United States, 54601

Contacts

Site Public Contact

608-775-2385cancerctr@gundersenhealth.org

Principal Investigator:

Kurt Oettel

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:

Ryan J. Mattison

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:

Ryan J. Mattison

Marshfield Medical Center-Marshfield

Recruiting

Marshfield, Wisconsin, United States, 54449

Contacts

Site Public Contact

800-782-8581oncology.clinical.trials@marshfieldresearch.org

Principal Investigator:

Kareem H. Abdelhadi

Medical College of Wisconsin

Recruiting

Milwaukee, Wisconsin, United States, 53226

Contacts

Site Public Contact

414-805-3666

Principal Investigator:

Ehab L. Atallah

Marshfield Medical Center - Minocqua

Recruiting

Minocqua, Wisconsin, United States, 54548

Contacts

Site Public Contact

800-782-8581oncology.clinical.trials@marshfieldresearch.org

Principal Investigator:

Kareem H. Abdelhadi

Marshfield Medical Center-Rice Lake

Recruiting

Rice Lake, Wisconsin, United States, 54868

Contacts

Site Public Contact

800-782-8581oncology.clinical.trials@marshfieldresearch.org

Principal Investigator:

Kareem H. Abdelhadi

Marshfield Medical Center-River Region at Stevens Point

Recruiting

Stevens Point, Wisconsin, United States, 54482

Contacts

Site Public Contact

800-782-8581oncology.clinical.trials@marshfieldresearch.org

Principal Investigator:

Kareem H. Abdelhadi

Marshfield Medical Center - Weston

Recruiting

Weston, Wisconsin, United States, 54476

Contacts

Site Public Contact

800-782-8581oncology.clinical.trials@marshfieldresearch.org

Principal Investigator:

Kareem H. Abdelhadi

More Information

Sponsor

National Cancer Institute (NCI)

Last update posted

Mar 27, 2026

Last verified

Feb, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-21. This information was provided to ClinicalTrials.gov by National Cancer Institute (NCI) on 2026-03-27.