Testing the Effects of Novel Therapeutics for Newly Diagnosed, Untreated Patients With High-Risk Acute Myeloid Leukemia (A MyeloMATCH Treatment Trial)

NCT ID: NCT05554406

Last Updated: 2025-11-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

335 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-09-25

Study Completion Date

2027-03-31

Brief Summary

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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.

Detailed Description

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PRIMARY OBJECTIVE:

I. To compare measurable residual disease (MRD) negative complete remission (CR) rates between each of the experimental regimens and cytarabine + daunorubicin (7+3).

SECONDARY OBJECTIVES:

I. To estimate the frequency and severity of toxicities with each of the regimens.

II. To estimate complete remission (CR) rates, complete remission with incomplete count recovery (CRi, with and without MRD) rates, event-free survival (EFS), time to relapse, relapse-free survival (RFS), and overall survival (OS) with each of the regimens.

III. To describe and compare MRD negative CR rates by genomic subgroups within and across randomized arms.

BAKING OBJECTIVE:

I. To bank specimens for future correlative studies.

OUTLINE: Patients are randomized to 1 of 5 arms.

ARM I: Patients receive cytarabine intravenously (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 echocardiography (ECHO) or multigated acquisition (MUGA) scan during screening. Patients also undergo a bone marrow aspiration and collection of blood throughout the trial.

ARM II: Patients receive cytarabine IV continuously on days 2-8 and daunorubicin IV on days 2-4 with venetoclax orally (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.

ARM III: Patients receive azacitidine subcutaneously (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.

ARM IV: 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.

ARM V: 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.

After completion of study treatment, patients follow up every month for first year, every 2 months for the second year, every 3 months for the third year and every 6 months to year 5.

Conditions

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Acute Myeloid Leukemia Acute Myeloid Leukemia Arising From Previous Myelodysplastic/Myeloproliferative Neoplasm Acute Myeloid Leukemia Post Cytotoxic Therapy Acute Myeloid Leukemia, Myelodysplasia-Related

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Biospecimen Collection

Intervention Type PROCEDURE

Undergo collection of blood

Bone Marrow Aspiration

Intervention Type PROCEDURE

Undergo bone marrow aspiration

Cytarabine

Intervention Type DRUG

Given IV

Daunorubicin Hydrochloride

Intervention Type DRUG

Given IV

Echocardiography Test

Intervention Type PROCEDURE

Undergo ECHO

Multigated Acquisition Scan

Intervention Type PROCEDURE

Undergo MUGA

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.

Group Type EXPERIMENTAL

Biospecimen Collection

Intervention Type PROCEDURE

Undergo collection of blood

Bone Marrow Aspiration

Intervention Type PROCEDURE

Undergo bone marrow aspiration

Cytarabine

Intervention Type DRUG

Given IV

Daunorubicin Hydrochloride

Intervention Type DRUG

Given IV

Echocardiography Test

Intervention Type PROCEDURE

Undergo ECHO

Multigated Acquisition Scan

Intervention Type PROCEDURE

Undergo MUGA

Venetoclax

Intervention Type DRUG

Given PO

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.

Group Type EXPERIMENTAL

Azacitidine

Intervention Type DRUG

Given SC or IV

Biospecimen Collection

Intervention Type PROCEDURE

Undergo collection of blood

Echocardiography Test

Intervention Type PROCEDURE

Undergo ECHO

Multigated Acquisition Scan

Intervention Type PROCEDURE

Undergo MUGA

Venetoclax

Intervention Type DRUG

Given PO

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.

Group Type EXPERIMENTAL

Biospecimen Collection

Intervention Type PROCEDURE

Undergo collection of blood

Bone Marrow Aspiration

Intervention Type PROCEDURE

Undergo bone marrow aspiration

Echocardiography Test

Intervention Type PROCEDURE

Undergo ECHO

Liposome-encapsulated Daunorubicin-Cytarabine

Intervention Type DRUG

Given IV

Multigated Acquisition Scan

Intervention Type PROCEDURE

Undergo MUGA

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.

Group Type EXPERIMENTAL

Biospecimen Collection

Intervention Type PROCEDURE

Undergo collection of blood

Bone Marrow Aspiration

Intervention Type PROCEDURE

Undergo bone marrow aspiration

Echocardiography Test

Intervention Type PROCEDURE

Undergo ECHO

Liposome-encapsulated Daunorubicin-Cytarabine

Intervention Type DRUG

Given IV

Multigated Acquisition Scan

Intervention Type PROCEDURE

Undergo MUGA

Venetoclax

Intervention Type DRUG

Given PO

Interventions

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Azacitidine

Given SC or IV

Intervention Type DRUG

Biospecimen Collection

Undergo collection of blood

Intervention Type PROCEDURE

Bone Marrow Aspiration

Undergo bone marrow aspiration

Intervention Type PROCEDURE

Cytarabine

Given IV

Intervention Type DRUG

Daunorubicin Hydrochloride

Given IV

Intervention Type DRUG

Echocardiography Test

Undergo ECHO

Intervention Type PROCEDURE

Liposome-encapsulated Daunorubicin-Cytarabine

Given IV

Intervention Type DRUG

Multigated Acquisition Scan

Undergo MUGA

Intervention Type PROCEDURE

Venetoclax

Given PO

Intervention Type DRUG

Other Intervention Names

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5 AZC 5-AC 5-Azacitidine 5-Azacytidine 5-AZC Azacytidine Azacytidine, 5- Ladakamycin Mylosar U-18496 Vidaza Biological Sample Collection Biospecimen Collected Specimen Collection .beta.-Cytosine arabinoside 1-.beta.-D-Arabinofuranosyl-4-amino-2(1H)pyrimidinone 1-.beta.-D-Arabinofuranosylcytosine 1-Beta-D-arabinofuranosyl-4-amino-2(1H)pyrimidinone 1-Beta-D-arabinofuranosylcytosine 1.beta.-D-Arabinofuranosylcytosine 2(1H)-Pyrimidinone, 4-Amino-1-beta-D-arabinofuranosyl- 2(1H)-Pyrimidinone, 4-amino-1.beta.-D-arabinofuranosyl- Alexan Ara-C ARA-cell Arabine Arabinofuranosylcytosine Arabinosylcytosine Aracytidine Aracytin Aracytine Beta-Cytosine Arabinoside CHX-3311 Cytarabinum Cytarbel Cytosar Cytosine Arabinoside Cytosine-.beta.-arabinoside Cytosine-beta-arabinoside Erpalfa Starasid Tarabine PFS U 19920 U-19920 Udicil WR-28453 Cerubidin Cerubidine Cloridrato de Daunorubicina Daunoblastin Daunoblastina Daunoblastine Daunomycin Hydrochloride Daunomycin, hydrochloride Daunorubicin.HCl Daunorubicini Hydrochloridum FI-6339 Ondena RP-13057 Rubidomycin Hydrochloride Rubilem EC Echocardiography CPX 351 CPX-351 CPX351 Cytarabine and Daunorubicin Liposomal Cytarabine-Daunorubicin Liposome for Injection Daunorubicin and Cytarabine (Liposomal) Liposomal AraC-Daunorubicin CPX-351 Liposomal Cytarabine-Daunorubicin Liposome-encapsulated Combination of Daunorubicin and Cytarabine Vyxeos Blood Pool Scan Equilibrium Radionuclide Angiography Gated Blood Pool Imaging Gated Heart Pool Scan MUGA MUGA Scan Multi-Gated Acquisition Scan Radionuclide Ventriculogram Scan Radionuclide Ventriculography RNV Scan RNVG SYMA Scanning Synchronized Multigated Acquisition Scanning ABT 199 ABT-0199 ABT-199 ABT199 GDC 0199 GDC-0199 GDC0199 RG7601 Venclexta Venclyxto

Eligibility Criteria

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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 the 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
* Acute promyelocytic leukemia is excluded
* Participants with favorable or intermediate risk disease 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 is allowed prior to study entry
* Prior anthracycline therapy is allowed but must not exceed a cumulative lifetime dose of 200 mg/m\^2 daunorubicin or equivalent. Prior hypomethylating agent (HMA) exposure is allowed, as long as not for AML diagnosis
* 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.
* 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 history and physical (H\&P) completed within 14 days prior to registration
* Participants must have a complete medical history and physical exam 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 known human immunodeficiency virus (HIV)-infection must be on effective anti-retroviral therapy at time of registration and have undetectable HIV viral load within 6 months prior to registration
* Participants with evidence 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 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 28 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), and 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
* 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 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 the myeloMATCH MSRP and specimens must be submitted
* 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
* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

59 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Paul J Shami

Role: PRINCIPAL_INVESTIGATOR

SWOG Cancer Research Network

Locations

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University of Alabama at Birmingham Cancer Center

Birmingham, Alabama, United States

Site Status RECRUITING

Mayo Clinic Hospital in Arizona

Phoenix, Arizona, United States

Site Status RECRUITING

Banner University Medical Center - Tucson

Tucson, Arizona, United States

Site Status RECRUITING

University of Arizona Cancer Center-North Campus

Tucson, Arizona, United States

Site Status RECRUITING

University of Arkansas for Medical Sciences

Little Rock, Arkansas, United States

Site Status RECRUITING

Alta Bates Summit Medical Center-Herrick Campus

Berkeley, California, United States

Site Status RECRUITING

Cedars Sinai Medical Center

Los Angeles, California, United States

Site Status RECRUITING

University of California Davis Comprehensive Cancer Center

Sacramento, California, United States

Site Status RECRUITING

UCSF Medical Center-Parnassus

San Francisco, California, United States

Site Status RECRUITING

Mills Health Center

San Mateo, California, United States

Site Status RECRUITING

Yale University

New Haven, Connecticut, United States

Site Status RECRUITING

Mayo Clinic in Florida

Jacksonville, Florida, United States

Site Status RECRUITING

Phoebe Putney Memorial Hospital

Albany, Georgia, United States

Site Status RECRUITING

Augusta University Medical Center

Augusta, Georgia, United States

Site Status SUSPENDED

Hawaii Cancer Care Inc - Waterfront Plaza

Honolulu, Hawaii, United States

Site Status RECRUITING

Straub Clinic and Hospital

Honolulu, Hawaii, United States

Site Status RECRUITING

Kapiolani Medical Center for Women and Children

Honolulu, Hawaii, United States

Site Status RECRUITING

Hawaii Cancer Care - Westridge

‘Aiea, Hawaii, United States

Site Status RECRUITING

Pali Momi Medical Center

‘Aiea, Hawaii, United States

Site Status RECRUITING

Saint Alphonsus Cancer Care Center-Boise

Boise, Idaho, United States

Site Status RECRUITING

Saint Luke's Cancer Institute - Boise

Boise, Idaho, United States

Site Status RECRUITING

Saint Alphonsus Cancer Care Center-Caldwell

Caldwell, Idaho, United States

Site Status RECRUITING

Kootenai Health - Coeur d'Alene

Coeur d'Alene, Idaho, United States

Site Status RECRUITING

Saint Luke's Cancer Institute - Fruitland

Fruitland, Idaho, United States

Site Status RECRUITING

Saint Luke's Cancer Institute - Meridian

Meridian, Idaho, United States

Site Status RECRUITING

Saint Alphonsus Cancer Care Center-Nampa

Nampa, Idaho, United States

Site Status RECRUITING

Saint Luke's Cancer Institute - Nampa

Nampa, Idaho, United States

Site Status RECRUITING

Kootenai Clinic Cancer Services - Post Falls

Post Falls, Idaho, United States

Site Status RECRUITING

Kootenai Clinic Cancer Services - Sandpoint

Sandpoint, Idaho, United States

Site Status RECRUITING

OSF Saint Joseph Medical Center

Bloomington, Illinois, United States

Site Status RECRUITING

Illinois CancerCare-Bloomington

Bloomington, Illinois, United States

Site Status RECRUITING

Illinois CancerCare-Canton

Canton, Illinois, United States

Site Status RECRUITING

Illinois CancerCare-Carthage

Carthage, Illinois, United States

Site Status RECRUITING

Northwestern University

Chicago, Illinois, United States

Site Status RECRUITING

University of Chicago Comprehensive Cancer Center

Chicago, Illinois, United States

Site Status RECRUITING

Cancer Care Specialists of Illinois - Decatur

Decatur, Illinois, United States

Site Status RECRUITING

Decatur Memorial Hospital

Decatur, Illinois, United States

Site Status RECRUITING

Illinois CancerCare-Dixon

Dixon, Illinois, United States

Site Status RECRUITING

Crossroads Cancer Center

Effingham, Illinois, United States

Site Status RECRUITING

Illinois CancerCare-Eureka

Eureka, Illinois, United States

Site Status RECRUITING

NorthShore University HealthSystem-Evanston Hospital

Evanston, Illinois, United States

Site Status RECRUITING

Illinois CancerCare-Galesburg

Galesburg, Illinois, United States

Site Status RECRUITING

NorthShore University HealthSystem-Glenbrook Hospital

Glenview, Illinois, United States

Site Status RECRUITING

NorthShore University HealthSystem-Highland Park Hospital

Highland Park, Illinois, United States

Site Status RECRUITING

Illinois CancerCare-Kewanee Clinic

Kewanee, Illinois, United States

Site Status RECRUITING

Illinois CancerCare-Macomb

Macomb, Illinois, United States

Site Status RECRUITING

Loyola University Medical Center

Maywood, Illinois, United States

Site Status RECRUITING

Cancer Care Center of O'Fallon

O'Fallon, Illinois, United States

Site Status RECRUITING

Illinois CancerCare-Ottawa Clinic

Ottawa, Illinois, United States

Site Status RECRUITING

Illinois CancerCare-Pekin

Pekin, Illinois, United States

Site Status RECRUITING

Illinois CancerCare-Peoria

Peoria, Illinois, United States

Site Status RECRUITING

Methodist Medical Center of Illinois

Peoria, Illinois, United States

Site Status RECRUITING

OSF Saint Francis Medical Center

Peoria, Illinois, United States

Site Status RECRUITING

Illinois CancerCare-Peru

Peru, Illinois, United States

Site Status RECRUITING

Illinois CancerCare-Princeton

Princeton, Illinois, United States

Site Status RECRUITING

Southern Illinois University School of Medicine

Springfield, Illinois, United States

Site Status RECRUITING

Springfield Clinic

Springfield, Illinois, United States

Site Status RECRUITING

Springfield Memorial Hospital

Springfield, Illinois, United States

Site Status RECRUITING

Illinois CancerCare - Washington

Washington, Illinois, United States

Site Status RECRUITING

Indiana University/Melvin and Bren Simon Cancer Center

Indianapolis, Indiana, United States

Site Status RECRUITING

University of Iowa/Holden Comprehensive Cancer Center

Iowa City, Iowa, United States

Site Status RECRUITING

University of Kansas Clinical Research Center

Fairway, Kansas, United States

Site Status RECRUITING

University of Kansas Cancer Center

Kansas City, Kansas, United States

Site Status RECRUITING

University of Kansas Hospital-Indian Creek Campus

Overland Park, Kansas, United States

Site Status RECRUITING

University of Kansas Hospital-Westwood Cancer Center

Westwood, Kansas, United States

Site Status RECRUITING

University of Kentucky/Markey Cancer Center

Lexington, Kentucky, United States

Site Status RECRUITING

The James Graham Brown Cancer Center at University of Louisville

Louisville, Kentucky, United States

Site Status RECRUITING

UofL Health Medical Center Northeast

Louisville, Kentucky, United States

Site Status RECRUITING

LSU Health Baton Rouge-North Clinic

Baton Rouge, Louisiana, United States

Site Status RECRUITING

Our Lady of the Lake Physician Group

Baton Rouge, Louisiana, United States

Site Status RECRUITING

Our Lady of The Lake

Baton Rouge, Louisiana, United States

Site Status RECRUITING

MaineHealth Maine Medical Center - Portland

Portland, Maine, United States

Site Status RECRUITING

MaineHealth Cancer Care and IV Therapy - South Portland

South Portland, Maine, United States

Site Status RECRUITING

Johns Hopkins University/Sidney Kimmel Cancer Center

Baltimore, Maryland, United States

Site Status RECRUITING

Tufts Medical Center

Boston, Massachusetts, United States

Site Status RECRUITING

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

Site Status RECRUITING

Lahey Hospital and Medical Center

Burlington, Massachusetts, United States

Site Status RECRUITING

Lahey Medical Center-Peabody

Peabody, Massachusetts, United States

Site Status RECRUITING

Trinity Health Saint Joseph Mercy Hospital Ann Arbor

Ann Arbor, Michigan, United States

Site Status RECRUITING

Trinity Health IHA Medical Group Hematology Oncology - Brighton

Brighton, Michigan, United States

Site Status RECRUITING

Trinity Health IHA Medical Group Hematology Oncology - Canton

Canton, Michigan, United States

Site Status RECRUITING

Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital

Chelsea, Michigan, United States

Site Status RECRUITING

Wayne State University/Karmanos Cancer Institute

Detroit, Michigan, United States

Site Status RECRUITING

Henry Ford Hospital

Detroit, Michigan, United States

Site Status RECRUITING

Weisberg Cancer Treatment Center

Farmington Hills, Michigan, United States

Site Status RECRUITING

Cancer Hematology Centers - Flint

Flint, Michigan, United States

Site Status RECRUITING

Genesee Hematology Oncology PC

Flint, Michigan, United States

Site Status SUSPENDED

Genesys Hurley Cancer Institute

Flint, Michigan, United States

Site Status RECRUITING

Hurley Medical Center

Flint, Michigan, United States

Site Status RECRUITING

Trinity Health Saint Mary Mercy Livonia Hospital

Livonia, Michigan, United States

Site Status RECRUITING

Henry Ford Medical Center-Columbus

Novi, Michigan, United States

Site Status RECRUITING

Henry Ford West Bloomfield Hospital

West Bloomfield, Michigan, United States

Site Status RECRUITING

Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus

Ypsilanti, Michigan, United States

Site Status RECRUITING

Mercy Hospital

Coon Rapids, Minnesota, United States

Site Status RECRUITING

Essentia Health - Deer River Clinic

Deer River, Minnesota, United States

Site Status RECRUITING

Essentia Health Cancer Center

Duluth, Minnesota, United States

Site Status RECRUITING

Fairview Southdale Hospital

Edina, Minnesota, United States

Site Status RECRUITING

Essentia Health Hibbing Clinic

Hibbing, Minnesota, United States

Site Status RECRUITING

Abbott-Northwestern Hospital

Minneapolis, Minnesota, United States

Site Status RECRUITING

Mayo Clinic in Rochester

Rochester, Minnesota, United States

Site Status RECRUITING

Park Nicollet Clinic - Saint Louis Park

Saint Louis Park, Minnesota, United States

Site Status RECRUITING

Regions Hospital

Saint Paul, Minnesota, United States

Site Status RECRUITING

United Hospital

Saint Paul, Minnesota, United States

Site Status RECRUITING

Essentia Health Sandstone

Sandstone, Minnesota, United States

Site Status RECRUITING

Essentia Health Virginia Clinic

Virginia, Minnesota, United States

Site Status RECRUITING

Baptist Memorial Hospital and Cancer Center-Golden Triangle

Columbus, Mississippi, United States

Site Status RECRUITING

Baptist Cancer Center-Grenada

Grenada, Mississippi, United States

Site Status RECRUITING

Baptist Memorial Hospital and Cancer Center-Union County

New Albany, Mississippi, United States

Site Status RECRUITING

Baptist Memorial Hospital and Cancer Center-Oxford

Oxford, Mississippi, United States

Site Status RECRUITING

Baptist Memorial Hospital and Cancer Center-Desoto

Southhaven, Mississippi, United States

Site Status RECRUITING

Siteman Cancer Center at Saint Peters Hospital

City of Saint Peters, Missouri, United States

Site Status RECRUITING

Siteman Cancer Center at West County Hospital

Creve Coeur, Missouri, United States

Site Status RECRUITING

Washington University School of Medicine

St Louis, Missouri, United States

Site Status RECRUITING

Siteman Cancer Center-South County

St Louis, Missouri, United States

Site Status RECRUITING

Siteman Cancer Center at Christian Hospital

St Louis, Missouri, United States

Site Status RECRUITING

Community Hospital of Anaconda

Anaconda, Montana, United States

Site Status RECRUITING

Billings Clinic Cancer Center

Billings, Montana, United States

Site Status RECRUITING

Bozeman Health Deaconess Hospital

Bozeman, Montana, United States

Site Status RECRUITING

Benefis Sletten Cancer Institute

Great Falls, Montana, United States

Site Status RECRUITING

Logan Health Medical Center

Kalispell, Montana, United States

Site Status RECRUITING

Community Medical Center

Missoula, Montana, United States

Site Status RECRUITING

Nebraska Medicine-Bellevue

Bellevue, Nebraska, United States

Site Status RECRUITING

Nebraska Medicine-Village Pointe

Omaha, Nebraska, United States

Site Status RECRUITING

University of Nebraska Medical Center

Omaha, Nebraska, United States

Site Status RECRUITING

OptumCare Cancer Care at Seven Hills

Henderson, Nevada, United States

Site Status RECRUITING

OptumCare Cancer Care at Charleston

Las Vegas, Nevada, United States

Site Status RECRUITING

OptumCare Cancer Care at Fort Apache

Las Vegas, Nevada, United States

Site Status RECRUITING

Cooper Hospital University Medical Center

Camden, New Jersey, United States

Site Status RECRUITING

Saint Barnabas Medical Center

Livingston, New Jersey, United States

Site Status RECRUITING

Monmouth Medical Center

Long Branch, New Jersey, United States

Site Status RECRUITING

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, United States

Site Status RECRUITING

The Valley Hospital - Luckow Pavilion

Paramus, New Jersey, United States

Site Status RECRUITING

Valley Health System Ridgewood Campus

Ridgewood, New Jersey, United States

Site Status RECRUITING

Community Medical Center

Toms River, New Jersey, United States

Site Status RECRUITING

University of New Mexico Cancer Center

Albuquerque, New Mexico, United States

Site Status RECRUITING

Roswell Park Cancer Institute

Buffalo, New York, United States

Site Status RECRUITING

Northwell Health/Center for Advanced Medicine

Lake Success, New York, United States

Site Status RECRUITING

North Shore University Hospital

Manhasset, New York, United States

Site Status RECRUITING

Mount Sinai Hospital

New York, New York, United States

Site Status RECRUITING

University of Rochester

Rochester, New York, United States

Site Status RECRUITING

State University of New York Upstate Medical University

Syracuse, New York, United States

Site Status RECRUITING

Montefiore Medical Center - Moses Campus

The Bronx, New York, United States

Site Status RECRUITING

Carolinas Medical Center/Levine Cancer Institute

Charlotte, North Carolina, United States

Site Status RECRUITING

Duke University Medical Center

Durham, North Carolina, United States

Site Status RECRUITING

Wake Forest University Health Sciences

Winston-Salem, North Carolina, United States

Site Status RECRUITING

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, United States

Site Status RECRUITING

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, United States

Site Status RECRUITING

Saint Alphonsus Cancer Care Center-Ontario

Ontario, Oregon, United States

Site Status RECRUITING

Providence Portland Medical Center

Portland, Oregon, United States

Site Status RECRUITING

Providence Saint Vincent Medical Center

Portland, Oregon, United States

Site Status RECRUITING

Oregon Health and Science University

Portland, Oregon, United States

Site Status RECRUITING

Lehigh Valley Hospital-Cedar Crest

Allentown, Pennsylvania, United States

Site Status RECRUITING

Geisinger Medical Center

Danville, Pennsylvania, United States

Site Status RECRUITING

Penn State Milton S Hershey Medical Center

Hershey, Pennsylvania, United States

Site Status RECRUITING

Lewistown Hospital

Lewistown, Pennsylvania, United States

Site Status RECRUITING

University of Pennsylvania/Abramson Cancer Center

Philadelphia, Pennsylvania, United States

Site Status RECRUITING

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, United States

Site Status RECRUITING

University of Pittsburgh Cancer Institute (UPCI)

Pittsburgh, Pennsylvania, United States

Site Status RECRUITING

Reading Hospital

West Reading, Pennsylvania, United States

Site Status RECRUITING

Prisma Health Cancer Institute - Spartanburg

Boiling Springs, South Carolina, United States

Site Status RECRUITING

Prisma Health Cancer Institute - Easley

Easley, South Carolina, United States

Site Status RECRUITING

Prisma Health Cancer Institute - Butternut

Greenville, South Carolina, United States

Site Status RECRUITING

Prisma Health Cancer Institute - Faris

Greenville, South Carolina, United States

Site Status RECRUITING

Prisma Health Cancer Institute - Eastside

Greenville, South Carolina, United States

Site Status RECRUITING

Prisma Health Cancer Institute - Greer

Greer, South Carolina, United States

Site Status RECRUITING

Prisma Health Cancer Institute - Seneca

Seneca, South Carolina, United States

Site Status RECRUITING

Baptist Memorial Hospital and Cancer Center-Collierville

Collierville, Tennessee, United States

Site Status RECRUITING

University of Tennessee - Knoxville

Knoxville, Tennessee, United States

Site Status RECRUITING

Baptist Memorial Hospital and Cancer Center-Memphis

Memphis, Tennessee, United States

Site Status RECRUITING

Huntsman Cancer Institute/University of Utah

Salt Lake City, Utah, United States

Site Status RECRUITING

University of Vermont Medical Center

Burlington, Vermont, United States

Site Status RECRUITING

University of Vermont and State Agricultural College

Burlington, Vermont, United States

Site Status RECRUITING

University of Virginia Cancer Center

Charlottesville, Virginia, United States

Site Status RECRUITING

Inova Schar Cancer Institute

Fairfax, Virginia, United States

Site Status RECRUITING

Inova Fairfax Hospital

Falls Church, Virginia, United States

Site Status RECRUITING

Swedish Cancer Institute-Edmonds

Edmonds, Washington, United States

Site Status RECRUITING

Swedish Cancer Institute-Issaquah

Issaquah, Washington, United States

Site Status RECRUITING

Swedish Medical Center-First Hill

Seattle, Washington, United States

Site Status RECRUITING

ThedaCare Regional Cancer Center

Appleton, Wisconsin, United States

Site Status RECRUITING

ThedaCare Regional Medical Center - Appleton

Appleton, Wisconsin, United States

Site Status RECRUITING

Duluth Clinic Ashland

Ashland, Wisconsin, United States

Site Status RECRUITING

Saint Vincent Hospital Cancer Center Green Bay

Green Bay, Wisconsin, United States

Site Status RECRUITING

Saint Vincent Hospital Cancer Center at Saint Mary's

Green Bay, Wisconsin, United States

Site Status RECRUITING

Gundersen Lutheran Medical Center

La Crosse, Wisconsin, United States

Site Status RECRUITING

Medical College of Wisconsin

Milwaukee, Wisconsin, United States

Site Status RECRUITING

Arthur J E Child Comprehensive Cancer Centre

Calgary, Alberta, Canada

Site Status RECRUITING

University of Alberta Hospital

Edmonton, Alberta, Canada

Site Status RECRUITING

CancerCare Manitoba

Winnipeg, Manitoba, Canada

Site Status RECRUITING

University Health Network-Princess Margaret Hospital

Toronto, Ontario, Canada

Site Status RECRUITING

Centro Comprensivo de Cancer de UPR

San Juan, , Puerto Rico

Site Status RECRUITING

San Juan City Hospital

San Juan, , Puerto Rico

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

United States Canada Puerto Rico

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

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Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

NCI-2022-07535

Identifier Type: REGISTRY

Identifier Source: secondary_id

MM1YA-S01

Identifier Type: OTHER

Identifier Source: secondary_id

MM1YA-S01

Identifier Type: OTHER

Identifier Source: secondary_id

U10CA180888

Identifier Type: NIH

Identifier Source: secondary_id

View Link

NCI-2022-07535

Identifier Type: -

Identifier Source: org_study_id