Recruiting
Phase 2

Venetoclax & HMA

Sponsor:

National Cancer Institute (NCI)

Code:

NCT06317649

Conditions

Acute Myeloid Leukemia

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Azacitidine

Biospecimen Collection

Bone Marrow Aspiration

Bone Marrow Biopsy

Gilteritinib

Study Details

Brief summary:

This phase II MyeloMATCH treatment trial compares the usual treatment of azacitidine and venetoclax to the combination treatment of azacitidine, venetoclax and gilteritinib in treating older and unfit patients with acute myeloid leukemia and FLT3 mutations. Azacitidine is a drug that is absorbed into DNA and leads to the activation of cancer suppressor genes, which are genes that help control cell growth. 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. Gilteritinib is in a class of medications called kinase inhibitors. It works by blocking the action of a certain naturally occurring substance that may be needed to help cancer cells multiply. This study may help doctors find out if these different approaches are better than the usual approaches. To decide if they are better, the study doctors are looking to see if the study drugs lead to a higher percentage of patients achieving a deeper remission compared to the usual approach.

Conditions

Acute Myeloid Leukemia

Study ID

NCT06317649

Start date

Sep 27, 2024

Status verified date

Aug, 2026

Completion date

May 15, 2029

Anticipated

Primary completion date

May 15, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Patient must be ≥ 60 years of age or adults ˂ 60 who in the opinion of the treating physician are better served by azanucleoside-based therapy rather than intensive, cytarabine-based induction based on clinical status (i.e., performance status), organ dysfunction, or disease biology
  • Patient must have a morphologically confirmed diagnosis of AML as determined by the site and confirmed by the treatment verification team, excluding acute promyelocytic leukemia (APL) with PML-RARA, AML with RUNX1-RUNX1T1, or AML with CBFB-MYH11
  • Patient must have no prior therapy for AML with the exception of hydroxyurea, all-trans retinoic acid (ATRA), cytarabine-based emergency therapy or leukapheresis to ensure white blood cells (WBC) < 25,000/mm\^3 prior to starting venetoclax treatment
  • Patient must have no prior therapy with hypomethylating agents or FLT3 inhibitors
  • Patient must have the FLT3-ITD, D835, or I836del mutation based on MYELOMATCH Protocol
  • Patient must be assigned to this protocol by the MYELOMATCH Protocol
  • 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 randomization to rule out pregnancy A patient of childbearing potential is defined as anyone, 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 for the duration of their participation in the study. Contraception measures must continue for 30 days after the last dose of venetoclax for all patients who are able to conceive or father children and for 6 months after the last dose of gilteritinib for patients of childbearing potential and for 4 months after the last dose of gilteritinib for male patients with partners of childbearing potential. Patient must not breastfeed during treatment and for 2 months after treatment ends
  • Patient must have the ability to understand and the willingness to sign a written informed consent document. Patients with impaired decision-making capacity (IDMC) who have a legally authorized representative (LAR) or caregiver and/or family member available will also be considered eligible
  • Total bilirubin ≤ 2 X institutional upper limit of normal (ULN), unless thought to be elevated due to disease involvement or Gilbert's syndrome, in which case bilirubin ≤ 3 x ULN is allowed (must be obtained ≤ 14 days prior to randomization)
  • Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase \[SGOT\]) and alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \[SGPT\]) =< 3.0 x institutional ULN (must be obtained ≤ 14 days prior to randomization)
  • Creatinine clearance ≥ 30 mL/min (must be obtained ≤ 14 days prior to randomization)

  • Either measured or estimated by Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) Creatinine Equation (2021)
  • Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months of randomization are eligible for this trial
  • Patients who meet the criteria below must have had an electrocardiogram (ECG) performed with a corrected QT interval using Fridericia's correction (QTcF) interval within normal limits:

  • Patient < 75 years old with a history of cardiac arrythmia, atrial fibrillation, or irregular QTcF interval OR
  • Patient < 75 years old with known genetic predisposition to long QT syndrome OR
  • Any patient ≥ 75 years old OR
  • Any patient at risk for electrolyte abnormalities, including tumor lysis syndrome

  • Normal limits are QTcF ≤ 450 ms for males and QTcF ≤ 460 ms for females. Corrected QT interval method (QTcF) may follow institutional standards
  • NOTE: Since older patients and patients with cardiac disease are at risk for prolonged QTcF and many will require supportive care with agents that affect the QTcF, an ECG is recommended if clinically indicated as noted above. If the QTcF is prolonged (> 450 ms for males and > 460 ms for females), they should be treated on the Tier Advancement Pathway (TAP) instead of MM1OA-EA02. In patients where ECG is not clinically indicated, QTcF does not need to be documented
  • For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated
  • Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load
  • Patient must not have the medical necessity for ongoing treatment with a strong CYP3A4 inducing drug
  • Patients with a prior or concurrent 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
  • 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 should be class 2 or better
  • Patient must not have an uncontrolled infection

Study Design

Enrollment

147 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Regimen 1 (azacitidine, venetoclax)

INDUCTION: Patients receive azacitidine IV or SC on days 1-7 of each cycle and venetoclax PO on days 1-28 of each cycle. Treatment repeats every 28 days for up to 2 cycles or until bone marrow assessment shows at least an MLFS response or better ("better" defined as CR, CRi, CRh), in the absence of disease progression or unacceptable toxicity.

CONSOLIDATION: Patients receive azacitidine IV or SC on days 1-7 and venetoclax PO on days 1-28 of each cycle. Cycles repeat every 28 days for 2 years in the absence of disease progression or unacceptable toxicity.

Patients undergo bone marrow biopsy and aspiration as well as blood sample collection on the trial.

experimental: Regimen 2 (azacitidine, venetoclax, gilteritinib)

INDUCTION: Patients receive azacitidine IV or SC on days 1-7 and venetoclax and gilteritinib PO on days 1-28 of each cycle. Treatment repeats every 28 days for up to 2 cycles or until bone marrow assessment shows at least an MLFS response or better ("better" defined as CR, CRi, CRh), in the absence of disease progression or unacceptable toxicity.

CONSOLIDATION: Patients receive azacitidine IV or SC on days 1-5, venetoclax PO on days 1-7 and gilteritinib PO on days 1-28 of each cycle. Cycles repeat every 28 days for 2 years in the absence of disease progression or unacceptable toxicity.

Patients undergo bone marrow biopsy and aspiration as well as blood sample collection on the trial.

experimental: Regimen 3 (azacitidine, venetoclax, gilteritinib)

INDUCTION: Patients receive azacitidine IV or SC on days 1-7 and venetoclax PO on days 1-28, and gilteritinib PO on days 8-21 of each cycle. Treatment repeats every 28 days for up to 2 cycles or until bone marrow assessment shows at least an MLFS response or better ("better" defined as CR, CRi, CRh), in the absence of disease progression or unacceptable toxicity.

CONSOLIDATION: Patients receive azacitidine IV or SC on days 1-5, venetoclax PO on days 1-14 and gilteritinib PO on days 8-21 of each cycle. Cycles repeat every 28 days for 2 years in the absence of disease progression or unacceptable toxicity.

Patients undergo bone marrow biopsy and aspiration as well as blood sample collection on the trial.

Interventions

Azacitidine

Given IV or SC

Biospecimen Collection

Undergo blood sample collection

Bone Marrow Aspiration

Undergo bone marrow biopsy and aspiration

Bone Marrow Biopsy

Undergo bone marrow biopsy and aspiration

Gilteritinib

Given PO

Venetoclax

Given PO

Primary outcome measure

  • Rate of measured residual disease (MRD) negative complete remission (CR) [ Time Frame: Up to 4 cycles of treatment (1 cycle = 28 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

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

Kaiser Permanente Dublin

Recruiting

Dublin, California, United States, 94568

Contacts

Site Public Contact

877-642-4691

Principal Investigator:

Faisal N. Cheema

Kaiser Permanente-Fremont

Recruiting

Fremont, California, United States, 94538

Contacts

Site Public Contact

877-642-4691Kpoct@kp.org

Principal Investigator:

Faisal N. Cheema

Kaiser Permanente Fresno Orchard Plaza

Recruiting

Fresno, California, United States, 93720

Contacts

Site Public Contact

833-574-2273

Principal Investigator:

Faisal N. Cheema

Kaiser Permanente-Fresno

Recruiting

Fresno, California, United States, 93720

Contacts

Site Public Contact

877-642-4691Kpoct@kp.org

Principal Investigator:

Faisal N. Cheema

Cedars-Sinai Medical Center

Recruiting

Los Angeles, California, United States, 90048

Contacts

Principal Investigator:

Noah M. Merin

Kaiser Permanente- Modesto MOB II

Recruiting

Modesto, California, United States, 95356

Contacts

Site Public Contact

877-642-4691

Principal Investigator:

Faisal N. Cheema

Kaiser Permanente-Modesto

Recruiting

Modesto, California, United States, 95356

Contacts

Site Public Contact

877-642-4691Kpoct@kp.org

Principal Investigator:

Faisal N. Cheema

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

Kaiser Permanente Downtown Commons

Recruiting

Sacramento, California, United States, 95814

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

Kaiser Permanente-South Sacramento

Recruiting

Sacramento, California, United States, 95823

Contacts

Site Public Contact

877-642-4691Kpoct@kp.org

Principal Investigator:

Faisal N. Cheema

Kaiser Permanente-San Francisco

Recruiting

San Francisco, California, United States, 94115

Contacts

Site Public Contact

877-642-4691Kpoct@kp.org

Principal Investigator:

Faisal N. Cheema

UCSF Medical Center-Parnassus

Recruiting

San Francisco, California, United States, 94143

Contacts

Site Public Contact

877-827-3222

Principal Investigator:

Timothy Ferng

Kaiser Permanente-Santa Teresa-San Jose

Recruiting

San Jose, California, United States, 95119

Contacts

Site Public Contact

877-642-4691Kpoct@kp.org

Principal Investigator:

Faisal N. Cheema

Kaiser Permanente San Leandro

Recruiting

San Leandro, California, United States, 94577

Contacts

Site Public Contact

877-642-4691Kpoct@kp.org

Principal Investigator:

Faisal N. Cheema

Kaiser San Rafael-Gallinas

Recruiting

San Rafael, California, United States, 94903

Contacts

Site Public Contact

877-642-4691Kpoct@kp.org

Principal Investigator:

Faisal N. Cheema

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

Kaiser Permanente-Santa Rosa

Recruiting

Santa Rosa, California, United States, 95403

Contacts

Site Public Contact

877-642-4691Kpoct@kp.org

Principal Investigator:

Faisal N. Cheema

Kaiser Permanente-South San Francisco

Recruiting

South San Francisco, California, United States, 94080

Contacts

Site Public Contact

877-642-4691Kpoct@kp.org

Principal Investigator:

Faisal N. Cheema

Kaiser Permanente-Vallejo

Recruiting

Vallejo, California, United States, 94589

Contacts

Site Public Contact

877-642-4691Kpoct@kp.org

Principal Investigator:

Faisal N. Cheema

Kaiser Permanente-Walnut Creek

Recruiting

Walnut Creek, California, United States, 94596

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

Veterans Affairs Connecticut Healthcare System-West Haven Campus

Recruiting

West Haven, Connecticut, United States, 06516

Contacts

Site Public Contact

203-937-3421

Principal Investigator:

Alexander Pine

UF Health Cancer Institute - Gainesville

Recruiting

Gainesville, Florida, United States, 32610

Contacts

Site Public Contact

352-273-8010

Principal Investigator:

Dina G. Khalaf

Miami Cancer Institute

Recruiting

Miami, Florida, United States, 33176

Contacts

Site Public Contact

786-596-2000

Principal Investigator:

Firas El Chaer

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

Kaiser Permanente Moanalua Medical Center

Recruiting

Honolulu, Hawaii, United States, 96819

Contacts

Principal Investigator:

Faisal N. Cheema

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:

Alison K. Conlin

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:

Alison K. Conlin

Saint Luke's Cancer Institute - Meridian

Recruiting

Meridian, Idaho, United States, 83642

Contacts

Principal Investigator:

Alison K. Conlin

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:

Alison K. Conlin

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

Northwestern University

Recruiting

Chicago, Illinois, United States, 60611

Contacts

Principal Investigator:

Yasmin Abaza

University of Illinois

Recruiting

Chicago, Illinois, United States, 60612

Contacts

Site Public Contact

312-355-3046

Principal Investigator:

Noah Birch

University of Chicago Comprehensive Cancer Center

Recruiting

Chicago, Illinois, United States, 60637

Contacts

Principal Investigator:

Olatoyosi M. Odenike

Carle at The Riverfront

Recruiting

Danville, Illinois, United States, 61832

Contacts

Principal Investigator:

Suparna Mantha

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

Northwestern Medicine Cancer Center Kishwaukee

Recruiting

DeKalb, Illinois, United States, 60115

Contacts

Principal Investigator:

Yasmin Abaza

Carle Physician Group-Effingham

Recruiting

Effingham, Illinois, United States, 62401

Contacts

Principal Investigator:

Suparna Mantha

Crossroads Cancer Center

Recruiting

Effingham, Illinois, United States, 62401

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:

Robert M. Eisner

Northwestern Medicine Cancer Center Delnor

Recruiting

Geneva, Illinois, United States, 60134

Contacts

Principal Investigator:

Yasmin Abaza

NorthShore University HealthSystem-Glenbrook Hospital

Recruiting

Glenview, Illinois, United States, 60026

Contacts

Site Public Contact

847-570-2109

Principal Investigator:

Robert M. Eisner

Northwestern Medicine Glenview Outpatient Center

Recruiting

Glenview, Illinois, United States, 60026

Contacts

Site Public Contact

312-695-1102

Principal Investigator:

Yasmin Abaza

Northwestern Medicine Grayslake Outpatient Center

Recruiting

Grayslake, Illinois, United States, 60030

Contacts

Site Public Contact

312-695-1102

Principal Investigator:

Yasmin Abaza

NorthShore University HealthSystem-Highland Park Hospital

Recruiting

Highland Park, Illinois, United States, 60035

Contacts

Site Public Contact

847-570-2109

Principal Investigator:

Robert M. Eisner

Edward Hines Jr VA Hospital

Recruiting

Hines, Illinois, United States, 60141

Contacts

Site Public Contact

708-202-8387

Principal Investigator:

Jorgena Kosti-Schwartz

Northwestern Medicine Lake Forest Hospital

Recruiting

Lake Forest, Illinois, United States, 60045

Contacts

Principal Investigator:

Yasmin Abaza

Carle Physician Group-Mattoon/Charleston

Recruiting

Mattoon, Illinois, United States, 61938

Contacts

Principal Investigator:

Suparna Mantha

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

Northwestern Medicine Orland Park

Recruiting

Orland Park, Illinois, United States, 60462

Contacts

Principal Investigator:

Yasmin Abaza

University of Chicago Medicine-Orland Park

Recruiting

Orland Park, Illinois, United States, 60462

Contacts

Principal Investigator:

Olatoyosi M. Odenike

Memorial Hospital East

Recruiting

Shiloh, Illinois, United States, 62269

Contacts

Principal Investigator:

Ramzi Abboud

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

Carle Cancer Center

Recruiting

Urbana, Illinois, United States, 61801

Contacts

Principal Investigator:

Suparna Mantha

Northwestern Medicine Cancer Center Warrenville

Recruiting

Warrenville, Illinois, United States, 60555

Contacts

Principal Investigator:

Yasmin Abaza

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:

Jesus Gonzalez Lugo

University of Kansas Cancer Center

Recruiting

Kansas City, Kansas, United States, 66160

Contacts

Principal Investigator:

Jesus Gonzalez Lugo

University of Kansas Hospital-Indian Creek Campus

Recruiting

Overland Park, Kansas, United States, 66211

Contacts

Principal Investigator:

Jesus Gonzalez Lugo

Cotton O'Neil Cancer Center / Stormont Vail Health

Recruiting

Topeka, Kansas, United States, 66606

Contacts

Site Public Contact

785-270-4939

Principal Investigator:

Brandon R. Weckbaugh

University of Kansas Hospital-Westwood Cancer Center

Recruiting

Westwood, Kansas, United States, 66205

Contacts

Principal Investigator:

Jesus Gonzalez Lugo

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 Cancer Care and IV Therapy - Brunswick

Recruiting

Brunswick, Maine, United States, 04011

Contacts

Principal Investigator:

Pamela Egan

Mid Coast Hospital

Recruiting

Brunswick, Maine, United States, 04011

Contacts

Principal Investigator:

Pamela Egan

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

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 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

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

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:

Muhammad Raza

Baptist Cancer Center-Grenada

Recruiting

Grenada, Mississippi, United States, 38901

Contacts

Principal Investigator:

Muhammad Raza

Baptist Memorial Hospital and Cancer Center-Union County

Recruiting

New Albany, Mississippi, United States, 38652

Contacts

Principal Investigator:

Muhammad Raza

Baptist Memorial Hospital and Cancer Center-Oxford

Recruiting

Oxford, Mississippi, United States, 38655

Contacts

Principal Investigator:

Muhammad Raza

Baptist Memorial Hospital and Cancer Center-Desoto

Recruiting

Southhaven, Mississippi, United States, 38671

Contacts

Principal Investigator:

Muhammad Raza

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

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

Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center

Recruiting

Lebanon, New Hampshire, United States, 03756

Contacts

Principal Investigator:

Raphael A. Lizcano

Memorial Sloan Kettering Basking Ridge

Recruiting

Basking Ridge, New Jersey, United States, 07920

Contacts

Site Public Contact

212-639-7592

Principal Investigator:

Aaron D. Goldberg

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:

Aaron D. Goldberg

Memorial Sloan Kettering Bergen

Recruiting

Montvale, New Jersey, United States, 07645

Contacts

Site Public Contact

212-639-7592

Principal Investigator:

Aaron D. Goldberg

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:

Aaron D. Goldberg

Northwell Health/Center for Advanced Medicine

Recruiting

Lake Success, New York, United States, 11042

Contacts

Site Public Contact

516-734-8896

Principal Investigator:

Erin Jou

North Shore University Hospital

Recruiting

Manhasset, New York, United States, 11030

Contacts

Site Public Contact

516-734-8896

Principal Investigator:

Erin Jou

Memorial Sloan Kettering Cancer Center

Recruiting

New York, New York, United States, 10065

Contacts

Site Public Contact

212-639-7592

Principal Investigator:

Aaron D. Goldberg

University of Rochester

Recruiting

Rochester, New York, United States, 14642

Contacts

Site Public Contact

585-275-5830

Principal Investigator:

Eric J. Huselton

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

Carolinas Medical Center/Levine Cancer Institute

Recruiting

Charlotte, North Carolina, United States, 28203

Contacts

Site Public Contact

800-804-9376

Principal Investigator:

Michael R. Grunwald

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:

Timothy S. Pardee

Case Western Reserve University

Recruiting

Cleveland, Ohio, United States, 44106

Contacts

Principal Investigator:

Ali W. Bseiso

Ohio State University Comprehensive Cancer Center

Recruiting

Columbus, Ohio, United States, 43210

Contacts

Principal Investigator:

Jayanshu Jain

University of Oklahoma Health Sciences Center

Recruiting

Oklahoma City, Oklahoma, United States, 73104

Contacts

Principal Investigator:

Mohamad Khawandanah

Providence Newberg Medical Center

Recruiting

Newberg, Oregon, United States, 97132

Contacts

Principal Investigator:

Alison K. Conlin

Saint Alphonsus Cancer Care Center-Ontario

Recruiting

Ontario, Oregon, United States, 97914

Contacts

Principal Investigator:

Tareq Al baghdadi

Providence Willamette Falls Medical Center

Recruiting

Oregon City, Oregon, United States, 97045

Contacts

Principal Investigator:

Alison K. Conlin

Providence Portland Medical Center

Recruiting

Portland, Oregon, United States, 97213

Contacts

Principal Investigator:

Alison K. Conlin

Providence Saint Vincent Medical Center

Recruiting

Portland, Oregon, United States, 97225

Contacts

Principal Investigator:

Alison K. Conlin

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

University of Pennsylvania/Abramson Cancer Center

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

Principal Investigator:

Alexander E. Perl

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:

Muhammad Raza

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:

Muhammad Raza

Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center

Recruiting

Houston, Texas, United States, 77030

Contacts

Site Public Contact

713-798-1354burton@bcm.edu

Principal Investigator:

Tareq Abuasab

Ben Taub General Hospital

Recruiting

Houston, Texas, United States, 77030

Contacts

Site Public Contact

713-873-2000

Principal Investigator:

Tareq Abuasab

Huntsman Cancer Institute/University of Utah

Recruiting

Salt Lake City, Utah, United States, 84112

Contacts

Principal Investigator:

Paul J. Shami

George E Wahlen Department of Veterans Affairs Medical Center

Recruiting

Salt Lake City, Utah, United States, 84148

Contacts

Site Public Contact

801-582-1565

Principal Investigator:

Tsewang Tashi

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

VCU Massey Comprehensive Cancer Center

Recruiting

Richmond, Virginia, United States, 23298

Contacts

Principal Investigator:

Keri R. Maher

Swedish Cancer Institute-Edmonds

Recruiting

Edmonds, Washington, United States, 98026

Contacts

Principal Investigator:

Alison K. Conlin

Swedish Cancer Institute-Issaquah

Recruiting

Issaquah, Washington, United States, 98029

Contacts

Principal Investigator:

Alison K. Conlin

Fred Hutchinson Cancer Center

Recruiting

Seattle, Washington, United States, 98109

Contacts

Site Public Contact

800-804-8824

Principal Investigator:

Jacob S. Appelbaum

Swedish Medical Center-First Hill

Recruiting

Seattle, Washington, United States, 98122

Contacts

Principal Investigator:

Alison K. Conlin

University of Washington Medical Center - Montlake

Recruiting

Seattle, Washington, United States, 98195

Contacts

Site Public Contact

800-804-8824

Principal Investigator:

Jacob S. Appelbaum

ThedaCare Regional Cancer Center

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:

Brian L. Burnette

Saint Vincent Hospital Cancer Center at Saint Mary's

Recruiting

Green Bay, Wisconsin, United States, 54303

Contacts

Principal Investigator:

Brian L. Burnette

Gundersen Lutheran Medical Center

Recruiting

La Crosse, Wisconsin, United States, 54601

Contacts

Principal Investigator:

Kurt Oettel

William S Middleton VA Medical Center

Recruiting

Madison, Wisconsin, United States, 53705

Contacts

Site Public Contact

608-256-1901

Principal Investigator:

Christopher D. Fletcher

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:

Sameem M. Abedin

Saint Vincent Hospital Cancer Center at Oconto Falls

Recruiting

Oconto Falls, Wisconsin, United States, 54154

Contacts

Principal Investigator:

Brian L. Burnette

Saint Vincent Hospital Cancer Center at Sheboygan

Recruiting

Sheboygan, Wisconsin, United States, 53081

Contacts

Principal Investigator:

Brian L. Burnette

Marshfield Medical Center-River Region at Stevens Point

Recruiting

Stevens Point, Wisconsin, United States, 54482

Contacts

Principal Investigator:

Adedayo A. Onitilo

Saint Vincent Hospital Cancer Center at Sturgeon Bay

Recruiting

Sturgeon Bay, Wisconsin, United States, 54235-1495

Contacts

Principal Investigator:

Brian L. Burnette

Marshfield Medical Center - Weston

Recruiting

Weston, Wisconsin, United States, 54476

Contacts

Principal Investigator:

Adedayo A. Onitilo

More Information

Sponsor

National Cancer Institute (NCI)

Last update posted

Sep 2, 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 2026-09-02.