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RecruitingNCT05554393Updated Sep 28, 2026

Comparing Cytarabine + Daunorubicin Therapy Versus Cytarabine + Daunorubicin + Venetoclax Versus Venetoclax + Azacitidine in Younger Patients With Intermediate Risk AML (A MyeloMATCH Treatment Trial)

A Phase 2 interventional study of Azacitidine and Biospecimen Collection in Acute Myeloid Leukemia, sponsored by National Cancer Institute (NCI). Recruiting at 186 sites in 3 countries. Open to participants aged 18 Years to 59 Years. Per ClinicalTrials.gov, last updated 2026-09-28.

Sponsored by National Cancer Institute (NCI) · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
153
Allocation
Randomized
Ages
18 Years to 59 Years
Sex
All
01

Study summary

This phase II MyeloMATCH treatment trial compares cytarabine with daunorubicin versus cytarabine with daunorubicin and venetoclax versus venetoclax with azacitidine for the treatment of younger patients with intermediate risk acute myeloid leukemia (AML). Cytarabine is a drug that inhibits some of the enzymes needed for deoxyribonucleic acid (DNA) replication and repair and can slow or stop the growth of cancer cells. Daunorubicin is a drug that blocks a certain enzyme needed for cell division and DNA repair, and it may kill cancer 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. Azacitidine is a drug that interacts with DNA to activate tumor-suppressing genes, resulting in an anti-tumor effect. Adding venetoclax to cytarabine and daunorubicin, and adding venetoclax to azacitidine, may work better than the usual treatment of cytarabine with daunorubicin alone. To decide if they are better, the study doctors are looking to see if venetoclax increases the rate of elimination of AML in participants by 20% or more compared to the usual approach.

Read the detailed description

PRIMARY OBJECTIVE:

I. To compare the rates of undetectable measurable residual disease (MRD) in patients who achieve a complete remission (CR) after induction therapy with 7 +3 (cytarabine + daunorubicin hydrochloride [daunorubicin]) versus (vs.) azacitidine + venetoclax vs. 7+3 + venetoclax.

SECONDARY OBJECTIVES:

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

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

TERTIARY OBJECTIVES:

I. To evaluate response to therapy received according to genomic findings. II. To evaluate MRD kinetics by following patients with detectable MRD through Tier 2 and beyond.

III. To evaluate longer term outcomes by treatment arm, genomics, MRD outcome, and other features as patients receive additional myeloMATCH therapies to generate testable hypotheses for more precise patient selection for these therapies.

OUTLINE: Patients are randomized to 1 of 3 arms.

ARM I: Patients receive daunorubicin intravenously (IV) on days 2-4, cytarabine IV continuously on days 2-8, and venetoclax orally (PO) once daily (QD) on days 1-11. Cycle is 28 days and treatment is given in the absence of disease progression or unacceptable toxicity. Based on a bone marrow aspiration assessment (completed at the discretion of the treating investigator), patients may receive reinduction consisting of daunorubicin IV on days 2-3, cytarabine IV continuously on days 2-6, and venetoclax PO QD on days 1-8. Cycle is 28 days and treatment is given in the absence of disease progression or unacceptable toxicity. Patients also undergo bone marrow aspiration and collection of blood samples on study and as clinically indicated. Additionally, patients undergo echocardiography (ECHO) or multigated acquisition scan (MUGA) during screening.

ARM II: Patients receive azacitidine IV or subcutaneously (SC) on days 1-7 or days 1-5 and 8-9 and venetoclax PO QD on days 1-28 of each cycle. Cycles repeat every 28 days for a total of 2 cycles, in the absence of disease progression or unacceptable toxicity. Patients also undergo bone marrow aspiration and collection of blood samples on study and as clinically indicated. Additionally, patients undergo ECHO or MUGA during screening.

ARM III: Patients receive daunorubicin IV on days 1-3 and cytarabine IV, continuously, on days 1-7. Cycle is 28 days and treatment is given in the absence of disease progression or unacceptable toxicity. Based on a bone marrow aspiration assessment (completed at the discretion of the treating investigator), patients may receive reinduction consisting of cytarabine IV, continuously, on days 1-5 and daunorubicin IV on days 1-2. Cycle is 28 days and treatment is given in the absence of disease progression or unacceptable toxicity. Patients also undergo bone marrow aspiration and collection of blood samples on study and as clinically indicated. Additionally, patients undergo ECHO or MUGA during screening.

After completion of study treatment, patients are followed up at 4 weeks, every 3 months for 1 year every 6 months for the second year and yearly thereafter.

02

Conditions studied

  • Acute Myeloid Leukemia
03

Who can participate

Ages eligible
18 Years to 59 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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 Protocol Assignment Team, prior to registration to this study. Participants must have agreed to have specimens submitted for translational medicine and must be offered the opportunity to submit biosamples for banking for future research as per MYELOMATCH

    • Note: Pre-enrollment/diagnosis labs must have already been performed under MYELOMATCH

  • Previously untreated, de novo acute myeloid leukemia (AML) defined by >= 20% myeloblasts in the peripheral blood or bone marrow (as defined by the current World Health Organization [WHO] classification of myeloid neoplasms and acute leukemia) excluding all the following categories of AML:

    • Favorable cytogenetics: (t(8;21)q22;q22.1); RUNX1-RUNX1T1, inversion 16(p13.1;q22), t(16;16)(p13.1;q22); CBFB-MYH11
    • CEBPA biallelic mutations
    • NPM1 mutation
    • AML with PML-RARalpha
    • AML with any adverse cytogenetics, TP53 mutation, RUNX1 mutation, ASXL1, 11q23/KMT2 rearrangements
    • AML with FLT3-ITD mutation
    • Therapy related AML, or AML following a diagnosis of myelodysplasia or myeloproliferative neoplasm 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
  • Age 18-59 years at time of induction therapy
  • Eastern Cooperative Oncology Group (ECOG) performance status =\< 3
  • Total bilirubin =\< 2 x institutional upper limit of normal (ULN) (must be done within 10 days of enrollment)
  • Aspartate aminotransferase (AST) (serum glutamate pyruvate transaminase [SGPT]) and/or alanine aminotransferase (ALT) (serum glutamic-oxaloacetic transaminase [SGOT]) =\< 3 × institutional ULN (must be done within 10 days of enrollment)
  • Cardiac ejection fraction >= 50% (echocardiography or MUGA) (if clinically indicated must be done within 14 days of enrollment)
  • Calculated creatinine clearance >= 30 mL/min; Clearance to be calculated using Cockcroft formula (must be done within 10 days of enrollment)
  • White blood cells (WBC) must be =\< 25 x 10\^9/L. Hydroxyurea and leukapheresis are permitted to control the WBC prior to enrollment and initiation of protocol-defined therapy but must be stopped prior to the initiation of protocol therapy. Hydroxyurea +/- no more than a total of 2500 mg cytarabine over a total of multiple days for urgent cytoreduction is also permitted
  • 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 2B or better
  • Males and females of reproductive potential must have agreed to use a highly effective contraceptive method while on treatment and for 6 months after stopping study drug. A woman is considered to be of "childbearing potential" if she has had menses at any time in the preceding 12 consecutive months. In addition to routine contraceptive methods, "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, or vasectomy/vasectomized partner. However, if at any point a previously celibate patient 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.

Women of childbearing potential will have a pregnancy test to determine eligibility as part of the pre-study evaluation; this may include an ultrasound to rule-out pregnancy if a false-positive is suspected. Patient will be considered eligible if an ultrasound is negative for pregnancy

  • Patient consent must be appropriately obtained in accordance with applicable local and regulatory requirements. Each patient must sign a consent form prior to enrollment in the trial to document their willingness to participate
  • Patients must be accessible for treatment, response assessment and follow up. Patients enrolled on this trial must be treated and followed at the participating centre. Investigators must assure themselves the patients enrolled on this trial will be available for complete documentation of the treatment, adverse events, and follow-up.

Patients must agree to return to their primary care facility for any adverse events which may occur through the course of the trial

  • In accordance with Canadian Cancer Trials Group (CCTG) policy, protocol treatment is to begin within 7 working days of patient enrollment
  • Patients with known human immunodeficiency virus (HIV) infection who are on effective anti-retroviral therapy and have undetectable viral load within 6 months of enrollment are eligible for this trial
  • Participants with evidence of chronic hepatitis B virus (HBV) infection must have undetectable HBV viral load within 28 days of enrollment. Patients need to be on suppressive therapy, if indicated
  • Patients with a history of hepatitis C virus (HCV) infection who have been treated and cured are eligible. Patients who with active HCV infection who are currently being treated must have an undetectable HCV viral load within 28 days of enrollment to be eligible

Exclusion criteria

Exclusion Criteria:

  • Prior therapy for AML except for hydroxyurea and leukapheresis to control blood counts. The use of all-trans retinoic acid (ATRA) is permitted until a diagnosis of acute promyelocytic leukemia, if suspected, is ruled out
  • Patients who are receiving any other investigational agents
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to cytarabine, daunorubicin, azacitidine, venetoclax
  • Pregnant women are excluded from this study because venetoclax, cytarabine and azacitidine have the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with venetoclax, cytarabine and azacitidine breastfeeding should be discontinued if the mother is treated with venetoclax, cytarabine and azacitidine. These potential risks may also apply to other agents used in this study
  • Patients with isolated myeloid sarcoma are not eligible

  • Any other serious intercurrent illness, life threatening condition, organ system dysfunction, or medical condition judged by the local investigator to compromise the subject's safety (for example):

    • Active, uncontrolled bacterial, fungal, or viral infection
04

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
153 participants (estimated)

Study arms

  • Experimental
    ARM I (daunorubicin, cytarabine, venetoclax)

    Patients receive daunorubicin IV on days 2-4, cytarabine IV continuously on days 2-8, and venetoclax PO QD on days 1-11. Cycle is 28 days and treatment is given in the absence of disease progression or unacceptable toxicity. Based on a bone marrow aspiration assessment (completed at the discretion of the treating investigator), patients may receive reinduction consisting of daunorubicin IV on days 2-3, cytarabine IV continuously on days 2-6, and venetoclax PO QD on days 1-8. Cycle is 28 days and treatment is given in the absence of disease progression or unacceptable toxicity. Patients also undergo bone marrow aspiration and collection of blood samples on study and as clinically indicated. Additionally, patients undergo ECHO or MUGA during screening.

    Procedure: Biospecimen Collection · Procedure: Bone Marrow Aspiration · Drug: Cytarabine · Drug: Daunorubicin Hydrochloride · Procedure: Echocardiography Test · Procedure: Multigated Acquisition Scan · Drug: Venetoclax

  • Experimental
    ARM II (azacitidine, venetoclax)

    Patients receive azacitidine IV or SC on days 1-7 or days 1-5 and 8-9 and venetoclax PO QD on days 1-28 of each cycle. Cycles repeat every 28 days for a total of 2 cycles, in the absence of disease progression or unacceptable toxicity. Patients also undergo bone marrow aspiration and collection of blood samples on study and as clinically indicated. Additionally, patients undergo ECHO or MUGA during screening.

    Drug: Azacitidine · Procedure: Biospecimen Collection · Procedure: Bone Marrow Aspiration · Procedure: Echocardiography Test · Procedure: Multigated Acquisition Scan · Drug: Venetoclax

  • Active comparator
    ARM III (daunorubicin, cytarabine)

    Patients receive daunorubicin IV on days 1-3 and cytarabine IV, continuously, on days 1-7. Cycle is 28 days and treatment is given in the absence of disease progression or unacceptable toxicity. Based on a bone marrow aspiration assessment (completed at the discretion of the treating investigator), patients may receive reinduction consisting of cytarabine IV, continuously, on days 1-5 and daunorubicin IV on days 1-2. Cycle is 28 days and treatment is given in the absence of disease progression or unacceptable toxicity. Patients also undergo bone marrow aspiration and collection of blood samples on study and as clinically indicated. Additionally, patients undergo ECHO or MUGA during screening.

    Procedure: Biospecimen Collection · Procedure: Bone Marrow Aspiration · Drug: Cytarabine · Drug: Daunorubicin Hydrochloride · Procedure: Echocardiography Test · Procedure: Multigated Acquisition Scan

Interventions

  • DrugAzacitidine

    Given IV or SC

    Also known as: 5 AZC, 5-AC, 5-Azacitidine, 5-Azacytidine, 5-AZC, Azacytidine, Azacytidine, 5-, Ladakamycin, Mylosar, U-18496, Vidaza

  • ProcedureBiospecimen Collection

    Undergo collection of blood samples

    Also known as: Biological Sample Collection, Biospecimen Collected, Sample Collection, Specimen Collection

  • ProcedureBone Marrow Aspiration

    Undergo bone marrow aspiration

  • DrugCytarabine

    Given IV

    Also known as: .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

  • DrugDaunorubicin Hydrochloride

    Given IV

    Also known as: Cerubidin, Cerubidine, Cloridrato de Daunorubicina, Daunoblastin, Daunoblastina, Daunoblastine, Daunomycin Hydrochloride, Daunomycin, hydrochloride, Daunorubicin.HCl, Daunorubicini Hydrochloridum, FI-6339, Ondena, RP-13057, Rubidomycin Hydrochloride, Rubilem

  • ProcedureEchocardiography Test

    Undergo ECHO

    Also known as: EC, Echocardiography

  • ProcedureMultigated Acquisition Scan

    Undergo MUGA

    Also known as: 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

  • DrugVenetoclax

    Given PO

    Also known as: ABT 199, ABT-0199, ABT-199, ABT199, GDC 0199, GDC-0199, GDC0199, RG7601, Venclexta, Venclyxto

05

What researchers measure

Primary outcomes

  1. Measurable residual disease (MRD) undetectable complete remission (CR)

    Will assess after one induction cycle with or without the addition of venetoclax or two cycles of venetoclax and azacitidine. MRD by flow cytometry will be considered undetectable if ≤ 10\^-3. The MRD negative CR will be assessed using European LeukemiaNet (ELN) 2017 criteria \[Döhner 2017\]. The analysis population for the primary outcome will be all randomized patients with the intent to treat population. The MRD undetectable CR rate will be the number of patients with MRD undetectable CR divided by the total number of patients. The differences of MRD undetectable CR rates between the experimental groups and the control group will be estimated and the corresponding one-sided 90% confidence limit will be calculated using Normal distribution approximation. MRD non-evaluable patients will be considered as MRD positive.

    Time frame: Up to 2 cycles (56 days)

Secondary outcomes

  1. Frequency and severity of toxicities with each of the regimens

    All patients who have received at least one dose of study treatment will be included in the safety analysis. Adverse events will be graded using the Common Terminology Criteria for Adverse Events version 5.0. The incidence of adverse events will be summarized by type severity and relationship to the study drugs. A Fisher's exact test will be used to compare toxicities between the two arms, if needed.

    Time frame: Up to 10 years

  2. CR rates

    Will be assessed per 2017 ELN guidelines and will be tabulated. Exact 95% confidence intervals will be calculated.

    Time frame: Up to 2 cycles (56 days)

  3. Complete remission with incomplete count recovery (CRi)

    Will be assessed with and without MRD. Will be assessed per 2017 ELN guidelines and will be tabulated. Exact 95% confidence intervals will be calculated.

    Time frame: Up to 2 cycles (56 days)

  4. Event-free survival

    Patients not known to have any of these events are censored on the date of last contact. Will be described by the Kaplan-Meier estimate. The stratified log-rank test using the stratification factor at randomization will be used to test the difference between each experimental arms to the control arms.

    Time frame: From the date of randomization to the first: date of primary refractory disease; date of progressive disease; date off protocol therapy without CR or CRi; date of relapse from CR or CRi, or death from any cause, assessed up to 10 years

  5. Relapse-free survival

    Will be calculated for participants who have achieved a CR or CRi. For patients who have not relapsed or died, will be censored on the date of the last disease assessment. Will be described by the Kaplan-Meier estimate. The stratified log-rank test using the stratification factor at randomization will be used to test the difference between each experimental arms to the control arms.

    Time frame: From the time of CR or CRi, until the relapse from CR or CRi, or death from any cause, assessed up to 10 years

  6. Overall survival

    For patients who did not die, overall survival time will be censored at the time of last known alive date. Will be described by the Kaplan-Meier estimate. The stratified log-rank test using the stratification factor at randomization will be used to test the difference between each experimental arms to the control arms.

    Time frame: From enrollment to the time of death from any cause, assessed up to 10 years

  7. Responses to therapy received relative to genomic findings

    Will evaluate to gain insights toward more precise patient selection for optimal outcomes.

    Time frame: Up to 10 years

Other outcomes

  1. Comparative analysis by molecular characteristics

    Time frame: Up to 10 years

06

Study locations

178 of 186 sites recruiting
  • University of Alabama at Birmingham Cancer Center
    Birmingham, Alabama 35233, United States
    Recruiting
  • Banner University Medical Center - Tucson
    Tucson, Arizona 85719, United States
    Recruiting
  • University of Arizona Cancer Center-North Campus
    Tucson, Arizona 85719, United States
    Recruiting
  • University of Arkansas for Medical Sciences
    Little Rock, Arkansas 72205, United States
    • Site Public Contact · Contact · 501-686-8274
    • Ankur Varma · Principal investigator
    Recruiting
  • Alta Bates Summit Medical Center-Herrick Campus
    Berkeley, California 94704, United States
    Active, not recruiting
  • Cedars-Sinai Medical Center
    Los Angeles, California 90048, United States
    Recruiting
  • Kaiser Permanente-Oakland
    Oakland, California 94611, United States
    • Site Public Contact · Contact · Kpoct@kp.org · 877-642-4691
    • Faisal N. Cheema · Principal investigator
    Recruiting
  • Kaiser Permanente-Roseville
    Roseville, California 95661, United States
    • Site Public Contact · Contact · Kpoct@kp.org · 877-642-4691
    • Faisal N. Cheema · Principal investigator
    Recruiting
  • UCSF Medical Center-Parnassus
    San Francisco, California 94143, United States
    • Site Public Contact · Contact · 877-827-3222
    • Timothy Ferng · Principal investigator
    Recruiting
  • Kaiser Permanente Medical Center - Santa Clara
    Santa Clara, California 95051, United States
    • Site Public Contact · Contact · Kpoct@kp.org · 877-642-4691
    • Faisal N. Cheema · Principal investigator
    Recruiting
  • Yale University
    New Haven, Connecticut 06520, United States
    • Site Public Contact · Contact · canceranswers@yale.edu · 203-785-5702
    • Amer M. Zeidan · Principal investigator
    Recruiting
  • Miami Cancer Institute
    Miami, Florida 33176, United States
    • Site Public Contact · Contact · 786-596-2000
    • Firas El Chaer · Principal investigator
    Recruiting
  • Memorial Hospital West
    Pembroke Pines, Florida 33028, United States
    • Site Public Contact · Contact · 954-265-4325
    • Yehuda E. Deutsch · Principal investigator
    Recruiting
  • Phoebe Putney Memorial Hospital
    Albany, Georgia 31701, United States
    • Site Public Contact · Contact · ga_cares@augusta.edu · 229-312-0405
    • Vamsi Kota · Principal investigator
    Recruiting
  • Saint Alphonsus Cancer Care Center-Boise
    Boise, Idaho 83706, United States
    Recruiting
  • Saint Luke's Cancer Institute - Boise
    Boise, Idaho 83712, United States
    • Site Public Contact · Contact · eslinget@slhs.org · 208-381-2774
    • Charles W. Drescher · Principal investigator
    Recruiting
  • Saint Alphonsus Cancer Care Center-Caldwell
    Caldwell, Idaho 83605, United States
    Recruiting
  • Kootenai Health - Coeur d'Alene
    Coeur d'Alene, Idaho 83814, United States
    • Site Public Contact · Contact · mccinfo@mtcancer.org · 406-969-6060
    • John M. Schallenkamp · Principal investigator
    Recruiting
  • Saint Luke's Cancer Institute - Fruitland
    Fruitland, Idaho 83619, United States
    • Site Public Contact · Contact · eslinget@slhs.org · 208-381-2774
    • Charles W. Drescher · Principal investigator
    Recruiting
  • Saint Luke's Cancer Institute - Meridian
    Meridian, Idaho 83642, United States
    • Site Public Contact · Contact · eslinget@slhs.org · 208-381-2774
    • Charles W. Drescher · Principal investigator
    Recruiting
  • Saint Alphonsus Cancer Care Center-Nampa
    Nampa, Idaho 83687, United States
    • Site Public Contact · Contact · mccinfo@mtcancer.org · 406-969-6060
    • Tareq Al baghdadi · Principal investigator
    Recruiting
  • Saint Luke's Cancer Institute - Nampa
    Nampa, Idaho 83687, United States
    • Site Public Contact · Contact · eslinget@slhs.org · 208-381-2774
    • Charles W. Drescher · Principal investigator
    Recruiting
  • Kootenai Clinic Cancer Services - Post Falls
    Post Falls, Idaho 83854, United States
    • Site Public Contact · Contact · mccinfo@mtcancer.org · 406-969-6060
    • John M. Schallenkamp · Principal investigator
    Recruiting
  • Kootenai Clinic Cancer Services - Sandpoint
    Sandpoint, Idaho 83864, United States
    • Site Public Contact · Contact · mccinfo@mtcancer.org · 406-969-6060
    • John M. Schallenkamp · Principal investigator
    Recruiting
  • Centralia Oncology Clinic
    Centralia, Illinois 62801, United States
    Recruiting
  • Northwestern University
    Chicago, Illinois 60611, United States
    Recruiting
  • University of Chicago Comprehensive Cancer Center
    Chicago, Illinois 60637, United States
    Recruiting
  • Cancer Care Specialists of Illinois - Decatur
    Decatur, Illinois 62526, United States
    Recruiting
  • Decatur Memorial Hospital
    Decatur, Illinois 62526, United States
    Recruiting
  • Crossroads Cancer Center
    Effingham, Illinois 62401, United States
    Recruiting
  • NorthShore University HealthSystem-Evanston Hospital
    Evanston, Illinois 60201, United States
    • Site Public Contact · Contact · 847-570-2109
    • Amy Y. Wang · Principal investigator
    Recruiting
  • NorthShore University HealthSystem-Glenbrook Hospital
    Glenview, Illinois 60026, United States
    • Site Public Contact · Contact · 847-570-2109
    • Amy Y. Wang · Principal investigator
    Recruiting
  • NorthShore University HealthSystem-Highland Park Hospital
    Highland Park, Illinois 60035, United States
    • Site Public Contact · Contact · 847-570-2109
    • Amy Y. Wang · Principal investigator
    Recruiting
  • Loyola University Medical Center
    Maywood, Illinois 60153, United States
    • Site Public Contact · Contact · 708-226-4357
    • Stephanie B. Tsai · Principal investigator
    Recruiting
  • UC Comprehensive Cancer Center at Silver Cross
    New Lenox, Illinois 60451, United States
    Recruiting
  • Cancer Care Center of O'Fallon
    O'Fallon, Illinois 62269, United States
    Recruiting
  • University of Chicago Medicine-Orland Park
    Orland Park, Illinois 60462, United States
    Recruiting
  • Southern Illinois University School of Medicine
    Springfield, Illinois 62702, United States
    • Site Public Contact · Contact · 217-545-7929
    • Bryan A. Faller · Principal investigator
    Recruiting
  • Springfield Clinic
    Springfield, Illinois 62702, United States
    • Site Public Contact · Contact · 800-444-7541
    • Bryan A. Faller · Principal investigator
    Recruiting
  • Springfield Memorial Hospital
    Springfield, Illinois 62781, United States
    Recruiting
  • UChicago Medicine Northwest Indiana
    Crown Point, Indiana 46307, United States
    Recruiting
  • University of Iowa/Holden Comprehensive Cancer Center
    Iowa City, Iowa 52242, United States
    • Site Public Contact · Contact · 800-237-1225
    • Prajwal Dhakal · Principal investigator
    Recruiting
  • University of Kansas Clinical Research Center
    Fairway, Kansas 66205, United States
    Recruiting
  • University of Kansas Cancer Center
    Kansas City, Kansas 66160, United States
    Recruiting
  • University of Kansas Hospital-Indian Creek Campus
    Overland Park, Kansas 66211, United States
    Recruiting
  • University of Kansas Hospital-Westwood Cancer Center
    Westwood, Kansas 66205, United States
    Recruiting
  • University of Kentucky/Markey Cancer Center
    Lexington, Kentucky 40536, United States
    • Site Public Contact · Contact · 859-257-3379
    • Ayman Qasrawi · Principal investigator
    Recruiting
  • The James Graham Brown Cancer Center at University of Louisville
    Louisville, Kentucky 40202, United States
    • Site Public Contact · Contact · 502-562-3429
    • Mohamed M. Hegazi · Principal investigator
    Recruiting
  • UofL Health Medical Center Northeast
    Louisville, Kentucky 40245, United States
    • Site Public Contact · Contact · ctoinfo@louisville.edu · 502-852-2755
    • Mohamed M. Hegazi · Principal investigator
    Recruiting
  • LSU Health Baton Rouge-North Clinic
    Baton Rouge, Louisiana 70805, United States
    • Site Public Contact · Contact · research@ololrmc.com · 225-765-7659
    • Harry G. Sequeira Gross · Principal investigator
    Recruiting
  • Our Lady of the Lake Physician Group
    Baton Rouge, Louisiana 70808, United States
    • Site Public Contact · Contact · research@ololrmc.com · 225-765-7659
    • Harry G. Sequeira Gross · Principal investigator
    Recruiting
  • Our Lady of The Lake
    Baton Rouge, Louisiana 70808, United States
    • Site Public Contact · Contact · 225-765-7659
    • Harry G. Sequeira Gross · Principal investigator
    Recruiting
  • MaineHealth Maine Medical Center - Portland
    Portland, Maine 04102, United States
    Recruiting
  • MaineHealth Maine Medical Center- Scarborough
    Scarborough, Maine 04074, United States
    Recruiting
  • MaineHealth Cancer Care and IV Therapy - South Portland
    South Portland, Maine 04106, United States
    Recruiting
  • Walter Reed National Military Medical Center
    Bethesda, Maryland 20889-5600, United States
    • Site Public Contact · Contact · 301-319-2100
    • Ryan Jones · Principal investigator
    Recruiting
  • Tufts Medical Center
    Boston, Massachusetts 02111, United States
    Recruiting
  • Dana-Farber Cancer Institute
    Boston, Massachusetts 02215, United States
    • Site Public Contact · Contact · 877-442-3324
    • Eric S. Winer · Principal investigator
    Recruiting
  • Lahey Clinic
    Burlington, Massachusetts 01805, United States
    Recruiting
  • Lahey Clinic Peabody
    Peabody, Massachusetts 01960, United States
    Recruiting
  • Trinity Health IHA Medical Group Hematology Oncology - Brighton
    Brighton, Michigan 48114, United States
    Recruiting
  • Trinity Health IHA Medical Group Hematology Oncology - Canton
    Canton, Michigan 48188, United States
    Recruiting
  • Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital
    Chelsea, Michigan 48118, United States
    Recruiting
  • Henry Ford Macomb Hospital-Clinton Township
    Clinton Township, Michigan 48038, United States
    Active, not recruiting
  • Henry Ford Hospital
    Detroit, Michigan 48202, United States
    Active, not recruiting
  • Cancer Hematology Centers - Flint
    Flint, Michigan 48503, United States
    • Site Public Contact · Contact · wstrong@ghci.org · 810-762-8038
    • Tareq Al baghdadi · Principal investigator
    Recruiting
  • Genesee Hematology Oncology PC
    Flint, Michigan 48503, United States
    Suspended
  • Genesys Hurley Cancer Institute
    Flint, Michigan 48503, United States
    • Site Public Contact · Contact · wstrong@ghci.org · 810-762-8038
    • Tareq Al baghdadi · Principal investigator
    Recruiting
  • Hurley Medical Center
    Flint, Michigan 48503, United States
    • Site Public Contact · Contact · wstrong@ghci.org · 810-762-8038
    • Tareq Al baghdadi · Principal investigator
    Recruiting
  • Allegiance Health
    Jackson, Michigan 49201, United States
    Active, not recruiting
  • Trinity Health Saint Mary Mercy Livonia Hospital
    Livonia, Michigan 48154, United States
    Recruiting
  • Henry Ford Medical Center-Columbus
    Novi, Michigan 48377, United States
    Active, not recruiting
  • Trinity Health Saint Joseph Mercy Oakland Hospital
    Pontiac, Michigan 48341, United States
    Recruiting
  • Henry Ford West Bloomfield Hospital
    West Bloomfield, Michigan 48322, United States
    Active, not recruiting
  • Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus
    Ypsilanti, Michigan 48197, United States
    Recruiting
  • Mercy Hospital
    Coon Rapids, Minnesota 55433, United States
    Recruiting
  • Essentia Health - Deer River Clinic
    Deer River, Minnesota 56636, United States
    Recruiting
  • Essentia Health Cancer Center
    Duluth, Minnesota 55805, United States
    Recruiting
  • Fairview Southdale Hospital
    Edina, Minnesota 55435, United States
    Recruiting
  • Essentia Health Hibbing Clinic
    Hibbing, Minnesota 55746, United States
    • Site Public Contact · Contact · 218-786-3308
    • Bret E. Friday · Principal investigator
    Recruiting
  • Abbott-Northwestern Hospital
    Minneapolis, Minnesota 55407, United States
    Recruiting
  • Park Nicollet Clinic - Saint Louis Park
    Saint Louis Park, Minnesota 55416, United States
    Recruiting
  • Regions Hospital
    Saint Paul, Minnesota 55101, United States
    Recruiting
  • United Hospital
    Saint Paul, Minnesota 55102, United States
    Recruiting
  • Essentia Health Sandstone
    Sandstone, Minnesota 55072, United States
    Recruiting
  • Essentia Health Virginia Clinic
    Virginia, Minnesota 55792, United States
    Recruiting
  • Baptist Memorial Hospital and Cancer Center-Golden Triangle
    Columbus, Mississippi 39705, United States
    Recruiting
  • Baptist Cancer Center-Grenada
    Grenada, Mississippi 38901, United States
    Recruiting
  • Baptist Memorial Hospital and Cancer Center-Union County
    New Albany, Mississippi 38652, United States
    Recruiting
  • Baptist Memorial Hospital and Cancer Center-Oxford
    Oxford, Mississippi 38655, United States
    Recruiting
  • Baptist Memorial Hospital and Cancer Center-Desoto
    Southhaven, Mississippi 38671, United States
    Recruiting
  • Siteman Cancer Center at Saint Peters Hospital
    City of Saint Peters, Missouri 63376, United States
    • Site Public Contact · Contact · info@siteman.wustl.edu · 800-600-3606
    • Ramzi Abboud · Principal investigator
    Recruiting
  • Siteman Cancer Center at West County Hospital
    Creve Coeur, Missouri 63141, United States
    • Site Public Contact · Contact · info@siteman.wustl.edu · 800-600-3606
    • Ramzi Abboud · Principal investigator
    Recruiting
  • Washington University School of Medicine
    St Louis, Missouri 63110, United States
    • Site Public Contact · Contact · info@siteman.wustl.edu · 800-600-3606
    • Ramzi Abboud · Principal investigator
    Recruiting
  • Siteman Cancer Center-South County
    St Louis, Missouri 63129, United States
    • Site Public Contact · Contact · info@siteman.wustl.edu · 800-600-3606
    • Ramzi Abboud · Principal investigator
    Recruiting
  • Siteman Cancer Center at Christian Hospital
    St Louis, Missouri 63136, United States
    • Site Public Contact · Contact · info@siteman.wustl.edu · 800-600-3606
    • Ramzi Abboud · Principal investigator
    Recruiting
  • Community Hospital of Anaconda
    Anaconda, Montana 59711, United States
    • Site Public Contact · Contact · mccinfo@mtcancer.org · 406-969-6060
    • John M. Schallenkamp · Principal investigator
    Recruiting
  • Billings Clinic Cancer Center
    Billings, Montana 59101, United States
    Recruiting
  • Bozeman Health Deaconess Hospital
    Bozeman, Montana 59715, United States
    • Site Public Contact · Contact · mccinfo@mtcancer.org · 406-969-6060
    • John M. Schallenkamp · Principal investigator
    Recruiting
  • Benefis Sletten Cancer Institute
    Great Falls, Montana 59405, United States
    • Site Public Contact · Contact · mccinfo@mtcancer.org · 406-969-6060
    • John M. Schallenkamp · Principal investigator
    Recruiting

Showing the first 100 of 186 sites across 3 countries.

07

References and documents

Individual participant data

Plan to share: Yes — NCI is committed to sharing data in accordance with NIH policy. For more details on how clinical trial data is shared, access the link to the NIH data sharing policy page.

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT05554393
Lead sponsor
National Cancer Institute (NCI)
Responsible party
Sponsor
First posted
Sep 26, 2022
Start date
Sep 13, 2024
Primary completion
Dec 31, 2027 (estimated)
Completion
Dec 31, 2027 (estimated)
Last update
Sep 28, 2026

Study contacts

Mary L Savoie
principal investigator · Canadian Cancer Trials Group

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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