Recruiting
Phase 2

MyeloMATCH

Sponsor:

National Cancer Institute (NCI)

Code:

NCT05554406

Conditions

Acute Myeloid Leukemia

Acute Myeloid Leukemia Arising From Previous Myelodysplastic/Myeloproliferative Neoplasm

Acute Myeloid Leukemia Post Cytotoxic Therapy

Acute Myeloid Leukemia, Myelodysplasia-Related

Eligibility Criteria

Sex: All

Age: 18 - 59

Healthy Volunteers: Not accepted

Interventions

Azacitidine

Biospecimen Collection

Bone Marrow Aspiration

Cytarabine

Daunorubicin Hydrochloride

Study Details

Brief summary:

This phase II MyeloMATCH treatment trial tests whether the standard approach of cytarabine and daunorubicin in comparison to the following experimental regimens works to shrink cancer in patients with high risk acute myeloid leukemia (AML): 1) daunorubicin and cytarabine liposome alone; 2) cytarabine and daunorubicin with venetoclax; 3) azacitidine and venetoclax; 4) daunorubicin and cytarabine liposome and venetoclax. "High-risk" refers to traits that have been known to make the AML harder to treat. Cytarabine is in a class of medications called antimetabolites. It works by slowing or stopping the growth of cancer cells in the body. Daunorubicin is in a class of medications called anthracyclines. It also works by slowing or stopping the growth of cancer cells in the body. Azacitidine is in a class of medications called demethylation agents. It works by helping the bone marrow to produce normal blood cells and by killing abnormal cells. Venetoclax is in a class of medications called B-cell lymphoma-2 (BCL-2) inhibitors. It may stop the growth of cancer cells by blocking Bcl-2, a protein needed for cancer cell survival. There is evidence that these newer experimental treatment regimens may work better in getting rid of more AML compared to the standard approach of cytarabine and daunorubicin.

Conditions

Acute Myeloid Leukemia

Acute Myeloid Leukemia Arising From Previous Myelodysplastic/Myeloproliferative Neoplasm

Acute Myeloid Leukemia Post Cytotoxic Therapy

Acute Myeloid Leukemia, Myelodysplasia-Related

Study ID

NCT05554406

Start date

Sep 25, 2024

Status verified date

Aug, 2026

Completion date

Mar 31, 2027

Anticipated

Primary completion date

Mar 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 59

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • STEP 1 REGISTRATION:
  • Participants must have been registered to Master Screening and Re-Assessment Protocol, MYELOMATCH, prior to consenting to this study. Participants must have been assigned to this clinical trial, via MATCHBox, prior to registration to this study.

  • Note: Pre-enrollment/diagnosis labs must have already been performed under MYELOMATCH
  • Participants must have newly diagnosed, untreated acute myeloid leukemia (AML) per World Health Organization (WHO) criteria
  • Participants must have high-risk (adverse) AML per European LeukemiaNet (ELN) 2017 criteria
  • Participants with therapy-related AML (t-AML), or with AML evolving from an antecedent hematologic disorder (such as myeloproliferative neoplasm), or AML with myelodysplasia-related changes (AML-MRC) are eligible-unless they were previously treated
  • Acute promyelocytic leukemia is excluded
  • Participants with favorable or intermediate risk disease per ELN 2017 criteria are excluded
  • Participants with FLT3 mutations (ITD or TKD) are excluded
  • Participants with t(9;22) translocation are excluded
  • A single dose of intrathecal chemotherapy for AML is allowed prior to study entry
  • Prior anthracycline therapy for any indication is allowed but must not exceed a cumulative lifetime dose of 200 mg/m\^2 daunorubicin or equivalent
  • Participants must not have received or be currently receiving any prior therapy for acute myeloid leukemia. Hydroxyurea to control the white blood cells (WBC) is allowed prior to registration and initiation of protocol-defined therapy. All trans retinoic acid (ATRA) given until a diagnosis of acute promyelocytic leukemia is ruled out is also allowed. For urgent cytoreduction, cytarabine may be given either as a single dose or in multiple doses not to exceed 2500 mg
  • Participants must not be receiving or planning to receive any other investigational agents before completing protocol therapy
  • Participants must be between 18 and 59 years of age
  • Participants must have Zubrod performance status =< 3 as determined by a complete medical history and physical exam (H\&P) completed within 7 days prior to registration
  • Participants must be able to swallow and retain oral medications and have no known gastrointestinal disorders likely to interfere with absorption of oral medications
  • Participants with a known history of human immunodeficiency virus (HIV)-infection must be on effective anti-retroviral therapy at time of registration and have undetectable HIV viral load on the most recent test results obtained within 6 months prior to registration
  • Participants with a known history of chronic hepatitis B virus (HBV) infection must have undetectable HBV viral load within 28 days prior to registration and be on suppressive therapy, if indicated
  • Participants with a known history of hepatitis C virus (HCV) infection must have been treated and cured. Participants with active HCV infection who are currently on treatment must have an undetectable HCV viral load within 28 days prior to registration
  • The following tests must be performed within 14 days prior to registration to establish baseline values:

  • Complete blood count (CBC)/differential/platelets
  • Total bilirubin
  • Lactate dehydrogenase (LDH)
  • Albumin
  • Glucose
  • Fibrinogen
  • Participants must have adequate kidney function as evidenced by creatinine clearance >= 30mL/min (by Cockcroft Gault) within 7 days prior to registration
  • Participants must have adequate liver function as evidenced by aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3.0 x upper limit of normal (ULN) within 7 days prior to registration- unless elevations are considered due to leukemia in the opinion of the treating investigator
  • Total bilirubin =< 2.0 x ULN (or 5.0 x ULN if the participant has a history of Gilbert's disease) within 28 days prior to registration
  • Participants must have adequate cardiac function as determined by echocardiography or MUGA scan with an ejection fraction >= 50% within 28 days prior to registration
  • Participants with a prior or concurrent malignancy whose natural history (in the opinion of the treating physician) does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial. No concurrent therapies for such malignancy are allowed with the exception of hormonal therapy
  • Participants with central nervous system (CNS) disease are eligible for this trial and will be treated according to institutional guidelines with intrathecal chemotherapy for this aspect of their disease.
  • Participants with known history of Wilson's disease or other known copper-metabolism disorder are excluded
  • Participants must not be pregnant or nursing. Women/men of reproductive potential must have agreed to use 2 contraception methods. A woman is considered to be of "reproductive potential" if she has had menses at any time in the preceding 12 consecutive months. In addition to routine contraceptive methods (e.g., hormonal contraceptives \[examples include birth control pills, vaginal rings, or patches\] associated with inhibition of ovulation for at least 1 month prior to taking study drug), "effective contraception" also includes heterosexual celibacy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) defined as a hysterectomy, bilateral oophorectomy or bilateral tubal ligation. However, if at any point a previously celibate participant chooses to become heterosexually active during the time period for use of contraceptive measures outlined in the protocol, he/she is responsible for beginning contraceptive measures. A barrier method should be used during this study along with hormonal contraceptives from initial study drug administration to 30 days after the last dose of study drug as drug-drug interaction with venetoclax is unknown
  • Participants must have agreed to have specimens submitted for translational medicine (MRD) under MYELOMATCH and specimens must be submitted
  • Participants must be offered the opportunity to participate in specimen banking

  • Note: Specimens must be collected and submitted using the Southwest Oncology Group (SWOG) Specimen Tracking System
  • 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
  • As a part of the Oncology Patient Enrollment Network (OPEN) registration process the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system

Study Design

Enrollment

335 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Arm I (cytarabine, daunorubicin)

Patients receive cytarabine IV continuously on days 1-7 and daunorubicin IV on days 1-3 per standard approach of each cycle. Cycles repeat every 28 days for 1 cycle in the absence of disease progression or unacceptable toxicity. Patients may receive an additional cycle of cytarabine IV continuously on days 1-5 and daunorubicin IV on days 1-2. Patients undergo ECHO or MUGA scan during screening. Patients also undergo a bone marrow aspiration and collection of blood throughout the trial.

experimental: Arm II (cytarabine, daunorubicin, venetoclax)

Patients receive cytarabine IV continuously on days 2-8 and daunorubicin IV on days 2-4 with venetoclax PO on days 1-11 of each cycle. Cycles repeat every 28 days for 1 cycle in the absence of disease progression or unacceptable toxicity. Patients may receive an additional cycle of cytarabine IV continuously on days 2-6 and daunorubicin IV on days 2-3 with venetoclax PO on days 1-8. Patients undergo ECHO or MUGA scan during screening. Patients also undergo a bone marrow aspiration and collection of blood throughout the trial.

experimental: Arm III (azacitidine, venetoclax)

Patients receive azacitidine SC or IV on days 1-7 and venetoclax PO on days 1-28 of each cycle. Cycles repeat every 28 days for 2 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo ECHO or MUGA scan during screening. Patients also undergo a bone marrow aspiration and collection of blood throughout the trial.

experimental: Arm IV (daunorubicin and cytarabine liposome)

Patients receive daunorubicin and cytarabine liposome IV over 90 minutes on days 1, 3, and 5 of each cycle. Cycles repeat every 28 days for 1 cycle in the absence of disease progression or unacceptable toxicity. Patients may receive an additional cycle of daunorubicin and cytarabine liposome IV over 90 minutes on days 1 and 3. Patients undergo ECHO or MUGA scan during screening. Patients also undergo a bone marrow aspiration and collection of blood throughout the trial.

experimental: Arm V (daunorubicin and cytarabine liposome, venetoclax)

Patients receive daunorubicin and cytarabine liposome IV over 90 minutes on days 1, 3, and 5 and venetoclax PO on days 1-14 of each cycle. Cycles repeat every 28 days for 1 cycle in the absence of disease progression or unacceptable toxicity. Patients may receive an additional cycle of daunorubicin and cytarabine liposome IV over 90 minutes on days 1 and 3 and venetoclax PO on days 1-7. Patients undergo ECHO or MUGA scan during screening. Patients also undergo a bone marrow aspiration and collection of blood throughout the trial.

Interventions

Azacitidine

Given SC or IV

Biospecimen Collection

Undergo collection of blood

Bone Marrow Aspiration

Undergo bone marrow aspiration

Cytarabine

Given IV

Daunorubicin Hydrochloride

Given IV

Echocardiography Test

Undergo ECHO

Liposome-encapsulated Daunorubicin-Cytarabine

Given IV

Multigated Acquisition Scan

Undergo MUGA

Venetoclax

Given PO

Primary outcome measure

  • Minimal residual disease (MRD) response (Arm 1, 2, 4 and 5) [ Time Frame: After induction (28 days) or re-induction (56 days) ]
  • MRD response (Arm 3) [ Time Frame: After two cycles of therapy (56 days) ]

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:

Razan Mohty

Mayo Clinic Hospital in Arizona

Recruiting

Phoenix, Arizona, United States, 85054

Contacts

Site Public Contact

855-776-0015

Principal Investigator:

Antoine Saliba

Banner University Medical Center - Tucson

Recruiting

Tucson, Arizona, United States, 85719

Contacts

Site Public Contact

UACC-IIT@uacc.arizona.edu

Principal Investigator:

Sharad Khurana

University of Arizona Cancer Center-North Campus

Recruiting

Tucson, Arizona, United States, 85719

Contacts

Site Public Contact

UACC-IIT@uacc.arizona.edu

Principal Investigator:

Sharad Khurana

University of Arkansas for Medical Sciences

Recruiting

Little Rock, Arkansas, United States, 72205

Contacts

Site Public Contact

501-686-8274

Principal Investigator:

Ankur Varma

Cedars-Sinai Medical Center

Recruiting

Los Angeles, California, United States, 90048

Contacts

Principal Investigator:

Noah M. Merin

Kaiser Permanente-Oakland

Recruiting

Oakland, California, United States, 94611

Contacts

Site Public Contact

877-642-4691Kpoct@kp.org

Principal Investigator:

Faisal N. Cheema

Kaiser Permanente-Roseville

Recruiting

Roseville, California, United States, 95661

Contacts

Site Public Contact

877-642-4691Kpoct@kp.org

Principal Investigator:

Faisal N. Cheema

University of California Davis Comprehensive Cancer Center

Recruiting

Sacramento, California, United States, 95817

Contacts

Site Public Contact

916-734-3089

Principal Investigator:

Brian A. Jonas

UCSF Medical Center-Parnassus

Recruiting

San Francisco, California, United States, 94143

Contacts

Site Public Contact

877-827-3222

Principal Investigator:

Timothy Ferng

Kaiser Permanente Medical Center - Santa Clara

Recruiting

Santa Clara, California, United States, 95051

Contacts

Site Public Contact

877-642-4691Kpoct@kp.org

Principal Investigator:

Faisal N. Cheema

Yale University

Recruiting

New Haven, Connecticut, United States, 06520

Contacts

Principal Investigator:

Jan P. Bewersdorf

Mayo Clinic in Florida

Recruiting

Jacksonville, Florida, United States, 32224-9980

Contacts

Site Public Contact

855-776-0015

Principal Investigator:

Antoine Saliba

Miami Cancer Institute

Recruiting

Miami, Florida, United States, 33176

Contacts

Site Public Contact

786-596-2000

Principal Investigator:

Firas El Chaer

Memorial Hospital West

Recruiting

Pembroke Pines, Florida, United States, 33028

Contacts

Site Public Contact

954-265-4325

Principal Investigator:

Jonathan Feld

Phoebe Putney Memorial Hospital

Recruiting

Albany, Georgia, United States, 31701

Contacts

Principal Investigator:

Vamsi Kota

Augusta University Medical Center

Recruiting

Augusta, Georgia, United States, 30912

Contacts

Principal Investigator:

Vamsi Kota

Hawaii Cancer Care Inc - Waterfront Plaza

Recruiting

Honolulu, Hawaii, United States, 96813

Contacts

Principal Investigator:

Craig S. Boddy

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

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-Boise

Recruiting

Boise, Idaho, United States, 83706

Contacts

Principal Investigator:

Tareq Al baghdadi

Saint Luke's Cancer Institute - Boise

Recruiting

Boise, Idaho, United States, 83712

Contacts

Principal Investigator:

Charles W. Drescher

Saint Alphonsus Cancer Care Center-Caldwell

Recruiting

Caldwell, Idaho, United States, 83605

Contacts

Principal Investigator:

Tareq Al baghdadi

Kootenai Health - Coeur d'Alene

Recruiting

Coeur d'Alene, Idaho, United States, 83814

Contacts

Principal Investigator:

John M. Schallenkamp

Saint Luke's Cancer Institute - Fruitland

Recruiting

Fruitland, Idaho, United States, 83619

Contacts

Principal Investigator:

Charles W. Drescher

Saint Luke's Cancer Institute - Meridian

Recruiting

Meridian, Idaho, United States, 83642

Contacts

Principal Investigator:

Charles W. Drescher

Saint Alphonsus Cancer Care Center-Nampa

Recruiting

Nampa, Idaho, United States, 83687

Contacts

Principal Investigator:

Tareq Al baghdadi

Saint Luke's Cancer Institute - Nampa

Recruiting

Nampa, Idaho, United States, 83687

Contacts

Principal Investigator:

Charles W. Drescher

Kootenai Clinic Cancer Services - Post Falls

Recruiting

Post Falls, Idaho, United States, 83854

Contacts

Principal Investigator:

John M. Schallenkamp

Kootenai Clinic Cancer Services - Sandpoint

Recruiting

Sandpoint, Idaho, United States, 83864

Contacts

Principal Investigator:

John M. Schallenkamp

OSF Saint Joseph Medical Center

Recruiting

Bloomington, Illinois, United States, 61701

Contacts

Principal Investigator:

Bryan A. Faller

Illinois CancerCare-Bloomington

Recruiting

Bloomington, Illinois, United States, 61704

Contacts

Principal Investigator:

Bryan A. Faller

Illinois CancerCare-Canton

Recruiting

Canton, Illinois, United States, 61520

Contacts

Principal Investigator:

Bryan A. Faller

Illinois CancerCare-Carthage

Recruiting

Carthage, Illinois, United States, 62321

Contacts

Principal Investigator:

Bryan A. Faller

Northwestern University

Recruiting

Chicago, Illinois, United States, 60611

Contacts

Principal Investigator:

Jessica K. Altman

University of Chicago Comprehensive Cancer Center

Recruiting

Chicago, Illinois, United States, 60637

Contacts

Principal Investigator:

Olatoyosi M. Odenike

Cancer Care Specialists of Illinois - Decatur

Recruiting

Decatur, Illinois, United States, 62526

Contacts

Principal Investigator:

Bryan A. Faller

Decatur Memorial Hospital

Recruiting

Decatur, Illinois, United States, 62526

Contacts

Principal Investigator:

Bryan A. Faller

Illinois CancerCare-Dixon

Recruiting

Dixon, Illinois, United States, 61021

Contacts

Site Public Contact

815-285-7800

Principal Investigator:

Bryan A. Faller

Crossroads Cancer Center

Recruiting

Effingham, Illinois, United States, 62401

Contacts

Principal Investigator:

Bryan A. Faller

Illinois CancerCare-Eureka

Recruiting

Eureka, Illinois, United States, 61530

Contacts

Principal Investigator:

Bryan A. Faller

NorthShore University HealthSystem-Evanston Hospital

Recruiting

Evanston, Illinois, United States, 60201

Contacts

Site Public Contact

847-570-2109

Principal Investigator:

David L. Grinblatt

Illinois CancerCare-Galesburg

Recruiting

Galesburg, Illinois, United States, 61401

Contacts

Principal Investigator:

Bryan A. Faller

NorthShore University HealthSystem-Glenbrook Hospital

Recruiting

Glenview, Illinois, United States, 60026

Contacts

Site Public Contact

847-570-2109

Principal Investigator:

David L. Grinblatt

NorthShore University HealthSystem-Highland Park Hospital

Recruiting

Highland Park, Illinois, United States, 60035

Contacts

Site Public Contact

847-570-2109

Principal Investigator:

David L. Grinblatt

Illinois CancerCare-Kewanee Clinic

Recruiting

Kewanee, Illinois, United States, 61443

Contacts

Principal Investigator:

Bryan A. Faller

Illinois CancerCare-Macomb

Recruiting

Macomb, Illinois, United States, 61455

Contacts

Principal Investigator:

Bryan A. Faller

Loyola University Medical Center

Recruiting

Maywood, Illinois, United States, 60153

Contacts

Site Public Contact

708-226-4357

Principal Investigator:

Stephanie B. Tsai

UC Comprehensive Cancer Center at Silver Cross

Recruiting

New Lenox, Illinois, United States, 60451

Contacts

Principal Investigator:

Olatoyosi M. Odenike

Cancer Care Center of O'Fallon

Recruiting

O'Fallon, Illinois, United States, 62269

Contacts

Principal Investigator:

Bryan A. Faller

University of Chicago Medicine-Orland Park

Recruiting

Orland Park, Illinois, United States, 60462

Contacts

Principal Investigator:

Olatoyosi M. Odenike

Illinois CancerCare-Ottawa Clinic

Recruiting

Ottawa, Illinois, United States, 61350

Contacts

Principal Investigator:

Bryan A. Faller

Illinois CancerCare-Pekin

Recruiting

Pekin, Illinois, United States, 61554

Contacts

Principal Investigator:

Bryan A. Faller

Illinois CancerCare-Peoria

Recruiting

Peoria, Illinois, United States, 61615

Contacts

Principal Investigator:

Bryan A. Faller

Methodist Medical Center of Illinois

Recruiting

Peoria, Illinois, United States, 61636

Contacts

Principal Investigator:

Bryan A. Faller

OSF Saint Francis Medical Center

Recruiting

Peoria, Illinois, United States, 61637

Contacts

Principal Investigator:

Bryan A. Faller

Illinois CancerCare-Peru

Recruiting

Peru, Illinois, United States, 61354

Contacts

Principal Investigator:

Bryan A. Faller

Illinois CancerCare-Princeton

Recruiting

Princeton, Illinois, United States, 61356

Contacts

Principal Investigator:

Bryan A. Faller

Southern Illinois University School of Medicine

Recruiting

Springfield, Illinois, United States, 62702

Contacts

Site Public Contact

217-545-7929

Principal Investigator:

Bryan A. Faller

Springfield Clinic

Recruiting

Springfield, Illinois, United States, 62702

Contacts

Site Public Contact

800-444-7541

Principal Investigator:

Bryan A. Faller

Springfield Memorial Hospital

Recruiting

Springfield, Illinois, United States, 62781

Contacts

Principal Investigator:

Bryan A. Faller

Illinois CancerCare - Washington

Recruiting

Washington, Illinois, United States, 61571

Contacts

Principal Investigator:

Bryan A. Faller

UChicago Medicine Northwest Indiana

Recruiting

Crown Point, Indiana, United States, 46307

Contacts

Principal Investigator:

Olatoyosi M. Odenike

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

University of Iowa/Holden Comprehensive Cancer Center

Recruiting

Iowa City, Iowa, United States, 52242

Contacts

Site Public Contact

800-237-1225

Principal Investigator:

Prajwal Dhakal

University of Kansas Clinical Research Center

Recruiting

Fairway, Kansas, United States, 66205

Contacts

Principal Investigator:

Tara L. Lin

University of Kansas Cancer Center

Recruiting

Kansas City, Kansas, United States, 66160

Contacts

Principal Investigator:

Tara L. Lin

University of Kansas Hospital-Indian Creek Campus

Recruiting

Overland Park, Kansas, United States, 66211

Contacts

Principal Investigator:

Tara L. Lin

University of Kansas Hospital-Westwood Cancer Center

Recruiting

Westwood, Kansas, United States, 66205

Contacts

Principal Investigator:

Tara L. Lin

University of Kentucky/Markey Cancer Center

Recruiting

Lexington, Kentucky, United States, 40536

Contacts

Site Public Contact

859-257-3379

Principal Investigator:

Ayman Qasrawi

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

Principal Investigator:

Mohamed M. Hegazi

LSU Health Baton Rouge-North Clinic

Recruiting

Baton Rouge, Louisiana, United States, 70805

Contacts

Principal Investigator:

Harry G. Sequeira Gross

Our Lady of the Lake Physician Group

Recruiting

Baton Rouge, Louisiana, United States, 70808

Contacts

Principal Investigator:

Harry G. Sequeira Gross

Our Lady of The Lake

Recruiting

Baton Rouge, Louisiana, United States, 70808

Contacts

Site Public Contact

225-765-7659

Principal Investigator:

Harry G. Sequeira Gross

MaineHealth Maine Medical Center - Portland

Recruiting

Portland, Maine, United States, 04102

Contacts

Principal Investigator:

Pamela Egan

MaineHealth Maine Medical Center- Scarborough

Recruiting

Scarborough, Maine, United States, 04074

Contacts

Principal Investigator:

Pamela Egan

MaineHealth Cancer Care and IV Therapy - South Portland

Recruiting

South Portland, Maine, United States, 04106

Contacts

Principal Investigator:

Pamela Egan

Johns Hopkins University/Sidney Kimmel Cancer Center

Recruiting

Baltimore, Maryland, United States, 21287

Contacts

Principal Investigator:

Alexander J. Ambinder

Walter Reed National Military Medical Center

Recruiting

Bethesda, Maryland, United States, 20889-5600

Contacts

Site Public Contact

301-319-2100

Principal Investigator:

Ryan Jones

Tufts Medical Center

Recruiting

Boston, Massachusetts, United States, 02111

Contacts

Principal Investigator:

Andreas K. Klein

Beth Israel Deaconess Medical Center

Recruiting

Boston, Massachusetts, United States, 02215

Contacts

Site Public Contact

617-667-9925

Principal Investigator:

Malgorzata McMasters

Dana-Farber Cancer Institute

Recruiting

Boston, Massachusetts, United States, 02215

Contacts

Site Public Contact

877-442-3324

Principal Investigator:

Eric S. Winer

Lahey Clinic

Recruiting

Burlington, Massachusetts, United States, 01805

Contacts

Principal Investigator:

Hossein Sadrzadeh

Lahey Clinic Peabody

Recruiting

Peabody, Massachusetts, United States, 01960

Contacts

Principal Investigator:

Hossein Sadrzadeh

Trinity Health Saint Joseph Mercy Hospital Ann Arbor

Recruiting

Ann Arbor, Michigan, United States, 48106

Contacts

Principal Investigator:

Tareq Al baghdadi

Trinity Health IHA Medical Group Hematology Oncology - Brighton

Recruiting

Brighton, Michigan, United States, 48114

Contacts

Principal Investigator:

Tareq Al baghdadi

Trinity Health IHA Medical Group Hematology Oncology - Canton

Recruiting

Canton, Michigan, United States, 48188

Contacts

Principal Investigator:

Tareq Al baghdadi

Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital

Recruiting

Chelsea, Michigan, United States, 48118

Contacts

Principal Investigator:

Tareq Al baghdadi

Wayne State University/Karmanos Cancer Institute

Recruiting

Detroit, Michigan, United States, 48201

Contacts

Principal Investigator:

Vijendra Singh

Weisberg Cancer Treatment Center

Recruiting

Farmington Hills, Michigan, United States, 48334

Contacts

Principal Investigator:

Vijendra Singh

Cancer Hematology Centers - Flint

Recruiting

Flint, Michigan, United States, 48503

Contacts

Principal Investigator:

Tareq Al baghdadi

Genesys Hurley Cancer Institute

Recruiting

Flint, Michigan, United States, 48503

Contacts

Principal Investigator:

Tareq Al baghdadi

Hurley Medical Center

Recruiting

Flint, Michigan, United States, 48503

Contacts

Principal Investigator:

Tareq Al baghdadi

Trinity Health Saint Mary Mercy Livonia Hospital

Recruiting

Livonia, Michigan, United States, 48154

Contacts

Principal Investigator:

Tareq Al baghdadi

Trinity Health Saint Joseph Mercy Oakland Hospital

Recruiting

Pontiac, Michigan, United States, 48341

Contacts

Principal Investigator:

Tareq Al baghdadi

Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus

Recruiting

Ypsilanti, Michigan, United States, 48197

Contacts

Principal Investigator:

Tareq Al baghdadi

Mercy Hospital

Recruiting

Coon Rapids, Minnesota, United States, 55433

Contacts

Principal Investigator:

David M. King

Essentia Health - Deer River Clinic

Recruiting

Deer River, Minnesota, United States, 56636

Contacts

Principal Investigator:

Bret E. Friday

Essentia Health Cancer Center

Recruiting

Duluth, Minnesota, United States, 55805

Contacts

Principal Investigator:

Bret E. Friday

Fairview Southdale Hospital

Recruiting

Edina, Minnesota, United States, 55435

Contacts

Principal Investigator:

David M. King

Essentia Health Hibbing Clinic

Recruiting

Hibbing, Minnesota, United States, 55746

Contacts

Site Public Contact

218-786-3308

Principal Investigator:

Bret E. Friday

Abbott-Northwestern Hospital

Recruiting

Minneapolis, Minnesota, United States, 55407

Contacts

Principal Investigator:

David M. King

Mayo Clinic in Rochester

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

Site Public Contact

855-776-0015

Principal Investigator:

Antoine Saliba

Park Nicollet Clinic - Saint Louis Park

Recruiting

Saint Louis Park, Minnesota, United States, 55416

Contacts

Principal Investigator:

David M. King

Regions Hospital

Recruiting

Saint Paul, Minnesota, United States, 55101

Contacts

Principal Investigator:

David M. King

United Hospital

Recruiting

Saint Paul, Minnesota, United States, 55102

Contacts

Principal Investigator:

David M. King

Essentia Health Sandstone

Recruiting

Sandstone, Minnesota, United States, 55072

Contacts

Principal Investigator:

Bret E. Friday

Essentia Health Virginia Clinic

Recruiting

Virginia, Minnesota, United States, 55792

Contacts

Principal Investigator:

Bret E. Friday

Baptist Memorial Hospital and Cancer Center-Golden Triangle

Recruiting

Columbus, Mississippi, United States, 39705

Contacts

Principal Investigator:

Salil Goorha

Baptist Cancer Center-Grenada

Recruiting

Grenada, Mississippi, United States, 38901

Contacts

Principal Investigator:

Salil Goorha

Baptist Memorial Hospital and Cancer Center-Union County

Recruiting

New Albany, Mississippi, United States, 38652

Contacts

Principal Investigator:

Salil Goorha

Baptist Memorial Hospital and Cancer Center-Oxford

Recruiting

Oxford, Mississippi, United States, 38655

Contacts

Principal Investigator:

Salil Goorha

Baptist Memorial Hospital and Cancer Center-Desoto

Recruiting

Southhaven, Mississippi, United States, 38671

Contacts

Principal Investigator:

Salil Goorha

Siteman Cancer Center at Saint Peters Hospital

Recruiting

City of Saint Peters, Missouri, United States, 63376

Contacts

Principal Investigator:

Ramzi Abboud

Siteman Cancer Center at West County Hospital

Recruiting

Creve Coeur, Missouri, United States, 63141

Contacts

Principal Investigator:

Ramzi Abboud

Washington University School of Medicine

Recruiting

St Louis, Missouri, United States, 63110

Contacts

Principal Investigator:

Ramzi Abboud

Siteman Cancer Center-South County

Recruiting

St Louis, Missouri, United States, 63129

Contacts

Principal Investigator:

Ramzi Abboud

Siteman Cancer Center at Christian Hospital

Recruiting

St Louis, Missouri, United States, 63136

Contacts

Principal Investigator:

Ramzi Abboud

Community Hospital of Anaconda

Recruiting

Anaconda, Montana, United States, 59711

Contacts

Principal Investigator:

John M. Schallenkamp

Billings Clinic Cancer Center

Recruiting

Billings, Montana, United States, 59101

Contacts

Principal Investigator:

John M. Schallenkamp

Bozeman Health Deaconess Hospital

Recruiting

Bozeman, Montana, United States, 59715

Contacts

Principal Investigator:

John M. Schallenkamp

Benefis Sletten Cancer Institute

Recruiting

Great Falls, Montana, United States, 59405

Contacts

Principal Investigator:

John M. Schallenkamp

Logan Health Medical Center

Recruiting

Kalispell, Montana, United States, 59901

Contacts

Principal Investigator:

John M. Schallenkamp

Community Medical Center

Recruiting

Missoula, Montana, United States, 59804

Contacts

Principal Investigator:

John M. Schallenkamp

Nebraska Medicine-Bellevue

Recruiting

Bellevue, Nebraska, United States, 68123

Contacts

Principal Investigator:

Michael Haddadin

Nebraska Medicine-Village Pointe

Recruiting

Omaha, Nebraska, United States, 68118

Contacts

Site Public Contact

402-559-5600

Principal Investigator:

Michael Haddadin

University of Nebraska Medical Center

Recruiting

Omaha, Nebraska, United States, 68198

Contacts

Principal Investigator:

Michael Haddadin

OptumCare Cancer Care at Charleston

Recruiting

Las Vegas, Nevada, United States, 89102

Contacts

Principal Investigator:

John A. Ellerton

OptumCare Cancer Care at Fort Apache

Recruiting

Las Vegas, Nevada, United States, 89183

Contacts

Principal Investigator:

John A. Ellerton

Memorial Sloan Kettering Basking Ridge

Recruiting

Basking Ridge, New Jersey, United States, 07920

Contacts

Site Public Contact

212-639-7592

Principal Investigator:

James Yoon

Cooper Hospital University Medical Center

Recruiting

Camden, New Jersey, United States, 08103

Contacts

Site Public Contact

856-325-6757

Principal Investigator:

Michael Brister

Cooperman Barnabas Medical Center

Recruiting

Livingston, New Jersey, United States, 07039

Contacts

Site Public Contact

973-322-5200

Principal Investigator:

Neil D. Palmisiano

Monmouth Medical Center

Recruiting

Long Branch, New Jersey, United States, 07740

Contacts

Principal Investigator:

Neil D. Palmisiano

Memorial Sloan Kettering Monmouth

Recruiting

Middletown, New Jersey, United States, 07748

Contacts

Site Public Contact

212-639-7592

Principal Investigator:

James Yoon

Memorial Sloan Kettering Bergen

Recruiting

Montvale, New Jersey, United States, 07645

Contacts

Site Public Contact

212-639-7592

Principal Investigator:

James Yoon

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

The Valley Hospital - Luckow Pavilion

Recruiting

Paramus, New Jersey, United States, 07652

Contacts

Principal Investigator:

Jason Suh

Valley Health System Ridgewood Campus

Recruiting

Ridgewood, New Jersey, United States, 07450

Contacts

Principal Investigator:

Jason Suh

Community Medical Center

Recruiting

Toms River, New Jersey, United States, 08755

Contacts

Principal Investigator:

Neil D. Palmisiano

University of New Mexico Cancer Center

Recruiting

Albuquerque, New Mexico, United States, 87106

Contacts

Principal Investigator:

Charles Foucar

Roswell Park Cancer Institute

Recruiting

Buffalo, New York, United States, 14263

Contacts

Principal Investigator:

Eunice S. Wang

Memorial Sloan Kettering Commack

Recruiting

Commack, New York, United States, 11725

Contacts

Site Public Contact

212-639-7592

Principal Investigator:

James Yoon

Memorial Sloan Kettering Westchester

Recruiting

Harrison, New York, United States, 10604

Contacts

Site Public Contact

212-639-7592

Principal Investigator:

James Yoon

Northwell Health/Center for Advanced Medicine

Recruiting

Lake Success, New York, United States, 11042

Contacts

Site Public Contact

516-734-8896

Principal Investigator:

David Chitty

North Shore University Hospital

Recruiting

Manhasset, New York, United States, 11030

Contacts

Site Public Contact

516-734-8896

Principal Investigator:

David Chitty

Mount Sinai Hospital

Recruiting

New York, New York, United States, 10029

Contacts

Site Public Contact

212-824-7309CCTO@mssm.edu

Principal Investigator:

Douglas A. Tremblay

Memorial Sloan Kettering Cancer Center

Recruiting

New York, New York, United States, 10065

Contacts

Site Public Contact

212-639-7592

Principal Investigator:

James Yoon

University of Rochester

Recruiting

Rochester, New York, United States, 14642

Contacts

Site Public Contact

585-275-5830

Principal Investigator:

Kristen M. O'Dwyer

Stony Brook University Medical Center

Recruiting

Stony Brook, New York, United States, 11794

Contacts

Site Public Contact

800-862-2215

Principal Investigator:

Suhu Liu

State University of New York Upstate Medical University

Recruiting

Syracuse, New York, United States, 13210

Contacts

Site Public Contact

315-464-5476

Principal Investigator:

Teresa C. Gentile

Montefiore Medical Center - Moses Campus

Recruiting

The Bronx, New York, United States, 10467

Contacts

Principal Investigator:

Ioannis Mantzaris

Memorial Sloan Kettering Nassau

Recruiting

Uniondale, New York, United States, 11553

Contacts

Site Public Contact

212-639-7592

Principal Investigator:

James Yoon

Carolinas Medical Center/Levine Cancer Institute

Recruiting

Charlotte, North Carolina, United States, 28203

Contacts

Site Public Contact

800-804-9376

Principal Investigator:

Brittany K. Ragon

Duke University Medical Center

Recruiting

Durham, North Carolina, United States, 27710

Contacts

Site Public Contact

888-275-3853

Principal Investigator:

Harry P. Erba

East Carolina University

Recruiting

Greenville, North Carolina, United States, 27834

Contacts

Principal Investigator:

Darla K. Liles

Wake Forest University Health Sciences

Recruiting

Winston-Salem, North Carolina, United States, 27157

Contacts

Site Public Contact

336-713-6771

Principal Investigator:

Madelyn Burkart

Case Western Reserve University

Recruiting

Cleveland, Ohio, United States, 44106

Contacts

Principal Investigator:

Rebecca B. Klisovic

Ohio State University Comprehensive Cancer Center

Recruiting

Columbus, Ohio, United States, 43210

Contacts

Principal Investigator:

Alice S. Mims

University of Oklahoma Health Sciences Center

Recruiting

Oklahoma City, Oklahoma, United States, 73104

Contacts

Principal Investigator:

Manu Pandey

Saint Alphonsus Cancer Care Center-Ontario

Recruiting

Ontario, Oregon, United States, 97914

Contacts

Principal Investigator:

Tareq Al baghdadi

Providence Portland Medical Center

Recruiting

Portland, Oregon, United States, 97213

Contacts

Principal Investigator:

Charles W. Drescher

Providence Saint Vincent Medical Center

Recruiting

Portland, Oregon, United States, 97225

Contacts

Principal Investigator:

Charles W. Drescher

Lehigh Valley Hospital-Cedar Crest

Recruiting

Allentown, Pennsylvania, United States, 18103

Contacts

Principal Investigator:

Tareq Al baghdadi

Geisinger Medical Center

Recruiting

Danville, Pennsylvania, United States, 17822

Contacts

Principal Investigator:

Joseph J. Vadakara

Penn State Milton S Hershey Medical Center

Recruiting

Hershey, Pennsylvania, United States, 17033-0850

Contacts

Site Public Contact

717-531-3779CTO@hmc.psu.edu

Principal Investigator:

Joseph Cioccio

Lewistown Hospital

Recruiting

Lewistown, Pennsylvania, United States, 17044

Contacts

Principal Investigator:

Joseph J. Vadakara

University of Pennsylvania/Abramson Cancer Center

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

Principal Investigator:

Catherine E. Lai

Thomas Jefferson University Hospital

Recruiting

Philadelphia, Pennsylvania, United States, 19107

Contacts

Principal Investigator:

Chetan S. Jeurkar

UPMC Hillman Cancer Center

Recruiting

Pittsburgh, Pennsylvania, United States, 15232

Contacts

Site Public Contact

412-647-8073

Principal Investigator:

Annie P. Im

Reading Hospital

Recruiting

West Reading, Pennsylvania, United States, 19611

Contacts

Site Public Contact

610-988-9323

Principal Investigator:

Terrence P. Cescon

Geisinger Wyoming Valley/Henry Cancer Center

Recruiting

Wilkes-Barre, Pennsylvania, United States, 18711

Contacts

Principal Investigator:

Joseph J. Vadakara

Rhode Island Hospital

Recruiting

Providence, Rhode Island, United States, 02903

Contacts

Site Public Contact

401-444-1488

Principal Investigator:

John L. Reagan

Prisma Health Cancer Institute - Spartanburg

Recruiting

Boiling Springs, South Carolina, United States, 29316

Contacts

Principal Investigator:

Suzanne R. Fanning

Medical University of South Carolina

Recruiting

Charleston, South Carolina, United States, 29425

Contacts

Principal Investigator:

Praneeth Baratam

Prisma Health Cancer Institute - Easley

Recruiting

Easley, South Carolina, United States, 29640

Contacts

Principal Investigator:

Suzanne R. Fanning

Prisma Health Cancer Institute - Butternut

Recruiting

Greenville, South Carolina, United States, 29605

Contacts

Principal Investigator:

Suzanne R. Fanning

Prisma Health Cancer Institute - Faris

Recruiting

Greenville, South Carolina, United States, 29605

Contacts

Principal Investigator:

Suzanne R. Fanning

Prisma Health Cancer Institute - Eastside

Recruiting

Greenville, South Carolina, United States, 29615

Contacts

Principal Investigator:

Suzanne R. Fanning

Prisma Health Cancer Institute - Greer

Recruiting

Greer, South Carolina, United States, 29650

Contacts

Principal Investigator:

Suzanne R. Fanning

Prisma Health Cancer Institute - Seneca

Recruiting

Seneca, South Carolina, United States, 29672

Contacts

Principal Investigator:

Suzanne R. Fanning

Baptist Memorial Hospital and Cancer Center-Collierville

Recruiting

Collierville, Tennessee, United States, 38017

Contacts

Principal Investigator:

Salil Goorha

University of Tennessee - Knoxville

Recruiting

Knoxville, Tennessee, United States, 37920

Contacts

Site Public Contact

865-544-9773

Principal Investigator:

Clark Cutrer

Baptist Memorial Hospital and Cancer Center-Memphis

Recruiting

Memphis, Tennessee, United States, 38120

Contacts

Principal Investigator:

Salil Goorha

Huntsman Cancer Institute/University of Utah

Recruiting

Salt Lake City, Utah, United States, 84112

Contacts

Principal Investigator:

Paul J. Shami

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

University of Virginia Cancer Center

Recruiting

Charlottesville, Virginia, United States, 22908

Contacts

Principal Investigator:

Daniel R. Reed

Inova Schar Cancer Institute

Recruiting

Fairfax, Virginia, United States, 22031

Contacts

Principal Investigator:

Danielle A. Shafer

Inova Fairfax Hospital

Recruiting

Falls Church, Virginia, United States, 22042

Contacts

Principal Investigator:

Danielle A. Shafer

Swedish Cancer Institute-Edmonds

Recruiting

Edmonds, Washington, United States, 98026

Contacts

Principal Investigator:

Charles W. Drescher

Swedish Cancer Institute-Issaquah

Recruiting

Issaquah, Washington, United States, 98029

Contacts

Principal Investigator:

Charles W. Drescher

Swedish Medical Center-First Hill

Recruiting

Seattle, Washington, United States, 98122

Contacts

Principal Investigator:

Charles W. Drescher

ThedaCare Regional Cancer Center

Recruiting

Appleton, Wisconsin, United States, 54911

Contacts

Principal Investigator:

Yazhini Vallatharasu

ThedaCare Regional Medical Center - Appleton

Recruiting

Appleton, Wisconsin, United States, 54911

Contacts

Principal Investigator:

Yazhini Vallatharasu

Duluth Clinic Ashland

Recruiting

Ashland, Wisconsin, United States, 54806

Contacts

Principal Investigator:

Bret E. Friday

Saint Vincent Hospital Cancer Center Green Bay

Recruiting

Green Bay, Wisconsin, United States, 54301

Contacts

Principal Investigator:

Matthew L. Ryan

Saint Vincent Hospital Cancer Center at Saint Mary's

Recruiting

Green Bay, Wisconsin, United States, 54303

Contacts

Principal Investigator:

Matthew L. Ryan

Gundersen Lutheran Medical Center

Recruiting

La Crosse, Wisconsin, United States, 54601

Contacts

Principal Investigator:

David E. Marinier

University of Wisconsin Carbone Cancer Center - Eastpark Medical Center

Recruiting

Madison, Wisconsin, United States, 53718

Contacts

Principal Investigator:

Kieran D. Sahasrabudhe

University of Wisconsin Carbone Cancer Center - University Hospital

Recruiting

Madison, Wisconsin, United States, 53792

Contacts

Principal Investigator:

Kieran D. Sahasrabudhe

Medical College of Wisconsin

Recruiting

Milwaukee, Wisconsin, United States, 53226

Contacts

Site Public Contact

414-805-3666

Principal Investigator:

Guru Subramanian Guru Murthy

Marshfield Medical Center-River Region at Stevens Point

Recruiting

Stevens Point, Wisconsin, United States, 54482

Contacts

Principal Investigator:

Adedayo A. Onitilo

Marshfield Medical Center - Weston

Recruiting

Weston, Wisconsin, United States, 54476

Contacts

Principal Investigator:

Adedayo A. Onitilo

Arthur J E Child Comprehensive Cancer Centre

Recruiting

Calgary, Alberta, Canada, T2N 5G2

Contacts

Principal Investigator:

Mary L. Savoie

University of Alberta Hospital

Recruiting

Edmonton, Alberta, Canada, T6G 2B7

Contacts

Principal Investigator:

Joseph M. Brandwein

CancerCare Manitoba

Recruiting

Winnipeg, Manitoba, Canada, R3E 0V9

Contacts

Principal Investigator:

Brett L. Houston

QEII Health Sciences Centre/Nova Scotia Health Authority

Recruiting

Halifax, Nova Scotia, Canada, B3H 2Y9

Contacts

Site Public Contact

902-473-6000

Principal Investigator:

Curtis Marcoux

Ottawa Hospital and Cancer Center-General Campus

Recruiting

Ottawa, Ontario, Canada, K1H 8L6

Contacts

Site Public Contact

613-761-4395

Principal Investigator:

Mitchell Sabloff

University Health Network-Princess Margaret Hospital

Recruiting

Toronto, Ontario, Canada, M5G 2M9

Contacts

Principal Investigator:

Guillaume Richard-Carpentier

CSSS Champlain-Charles Le Moyne

Recruiting

Greenfield Park, Quebec, Canada, J4V 2H1

Contacts

Site Public Contact

450-466-5065

Principal Investigator:

Sami Morin-Ben Abdallah

CIUSSSEMTL-Hopital Maisonneuve-Rosemont

Recruiting

Montreal, Quebec, Canada, H1T 2M4

Contacts

Site Public Contact

514-252-3400

Principal Investigator:

Julie Bergeron

Jewish General Hospital

Recruiting

Montreal, Quebec, Canada, H3T 1E2

Contacts

Site Public Contact

514-340-8222

Principal Investigator:

Sarit E. Assouline

More Information

Sponsor

National Cancer Institute (NCI)

Last update posted

Aug 27, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by National Cancer Institute (NCI) on 2026-08-27.