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Could less be more? new trial shortens leukemia drug course for seniors

NCT ID NCT07437950

Disease control Sponsor: National Cancer Institute (NCI) Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 04, 2026 · Updated 12 times

Summary

This study looks at whether giving the drug venetoclax for a shorter time, along with the combination drug ASTX727, works as well as the usual longer course for adults aged 60 and older with newly diagnosed acute myeloid leukemia (AML) who are not healthy enough for strong chemotherapy. About 126 participants will be randomly assigned to one of two treatment schedules. The goal is to see if the shorter treatment can achieve the same deep remission with fewer side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 126 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Apr 2027

An estimate. Start dates often move.

Expected to finish

Sep 2034

An estimate. End dates often move.

Lead sponsor

A government research agency

The lead sponsor is the US National Institutes of Health.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

60 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Participants must have been registered to the MYELOMATCH Master Screening and Reassessment Protocol prior to consenting to this study. Participants must have been assigned to this clinical trial via MATCHBox prior to registration to this study. * Note: Pre-enrollment/diagnosis labs must have already been performed under MYELOMATCH * Participants must have newly diagnosed, untreated acute myeloid leukemia (AML) defined by * Having ≥ 20% blasts in the bone marrow and/or peripheral blood or * Having recurrent AML-specific genetic abnormalities with ≥ 10% blasts in the bone marrow aspirate and/or peripheral blood * Participants with acute promyelocytic leukemia (APL) with PML-RARA are not eligible * Participants must not have FLT3 mutations (ITD or TKD) * Participants must not have TP53 mutations * Participants must not be receiving or planning to receive any other investigational agents while on protocol therapy * Participants must not have received prior therapy for AML, myelodysplastic syndrome (MDS) or myeloproliferative neoplasm (MPN) with the exception of hydroxyurea, all-trans retinoic acid (ATRA), BCR-ABL directed tyrosine kinase inhibitor, colony-stimulating factors, erythropoiesis-stimulating agents, thrombopoietin receptor agonist, lenalidomide, immunosuppressive therapy, intrathecal chemotherapy, a cumulative dose of up to 1 g/m\^2 of cytarabine, and/or leukapheresis, with a maximum limit of 1 month of exposure * Note: White blood cell (WBC) must be \< 25 x 10\^9/L prior to start of treatment. Hydroxyurea, leukapheresis, and cytarabine ≤ 1g/m2 are permitted to control the WBC prior to enrollment and initiation of protocol-defined therapy but must be stopped prior to initiation of protocol therapy * Participant must be ≥ 60 years old at the time of registration * Participant must have been declared unfit for intensive therapy by the treating physician at the time of registration to MYELOMATCH * Participant must have Zubrod Performance Status of 0-3 within 28 days prior to registration * Participant must have a complete medical history and physical exam within 28 days prior to registration * Total bilirubin ≤ 3 x institutional upper limit of normal (ULN) unless history of Gilbert's disease. Participants with history of Gilbert's disease must have total bilirubin ≤ 5 x institutional ULN (within 28 days prior to registration) * Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) ≤ 3 x institutional ULN, unless considered elevated due to disease involvement (within 28 days prior to registration) * Participants must have a calculated creatinine clearance ≥ 30 mL/min using the following Cockcroft-Gault Formula. This specimen must have been drawn and processed within 28 days prior to registration. For creatinine clearance formula see the tools on the CRA Workbench https://txwb.crab.org/TXWB/Tools.aspx * Participants must have adequate cardiac function. Participants with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, must have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, participants must be class 3 or better * Participants with a known history of human immunodeficiency virus (HIV)-infection must be on effective anti-retroviral therapy at registration and have undetectable viral load test on the most recent test results obtained within 6 months prior to registration, if indicated * Participants with a known history of chronic hepatitis B virus (HBV) infection must have undetectable HBV viral load while on suppressive therapy on the most recent test results obtained within 6 months prior to registration, if indicated * Participants with a known history of hepatitis C virus (HCV) infection must have been treated and cured. Participants currently being treated for HCV infection must have undetectable HCV viral load test on the most recent test results obtained within 6 months prior to registration, if indicated * Participants must not have a prior or concurrent malignancy whose natural history or treatment (in the opinion of the treating physician) has the potential to interfere with the safety or efficacy assessment of the investigational regimen * Participants must not be pregnant or nursing (nursing includes breast milk fed to an infant by any means, including from the breast, milk expressed by hand, or pumped). Individuals who are of reproductive potential must have agreed to use an effective contraceptive method with details provided as a part of the consent process. A person who has had menses at any time in the preceding 12 consecutive months or who has semen likely to contain sperm is considered to be of "reproductive potential." In addition to routine contraceptive methods, "effective contraception" also includes refraining from sexual activity that might result in pregnancy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) including hysterectomy, bilateral oophorectomy, bilateral tubal ligation/occlusion, and vasectomy with testing showing no sperm in the semen * 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 must have agreed to have specimens submitted for translational medicine for MRD under MYELOMATCH. * Enrollment to this treatment study requires prior enrollment into the myeloMATCH Master Protocol (MYELOMATCH). Participants enrolled in MYELOMATCH will submit bone marrow samples, peripheral blood samples, and buccal swabs to the Molecular Diagnostics Network (MDNet), the Clinical Laboratory Improvement Act (CLIA) laboratory network for myeloMATCH. Refer to MYELOMATCH for submission requirements and directions. * In addition to the MYELOMATCH specimens, there will be specimens obtained on treatment for this substudy. These specimens will be derived from procedures performed as part of standard assessments in the clinical care and management of AML with material being sent to the MDNet laboratories as specified. After performing the required tests on the specimens, the MDNet laboratories will send the residual material for biobanking and future research. Therefore, participants must be asked for their consent for the biobanking of specimens for future unspecified research. Participants may refuse this, but it is mandatory for sites to ask participants * Participants must be offered the opportunity to participate in specimen banking * NOTE: As a part of the 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. * Participants must be informed of the investigational nature of this study and must sign and give informed consent in accordance with institutional and federal guidelines. * For participants with impaired decision-making capabilities, legally authorized representatives may sign and give informed consent on behalf of study participants in accordance with applicable federal, local, and Central Institutional Review Board (CIRB) regulations

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Conditions

The condition(s) this trial relates to.

acute myeloid leukemia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Acute myeloid leukemia

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    28 sites in 2 countries. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Cancer Care Specialists of Illinois - Decatur

    RECRUITING

    Decatur, Illinois, 62526, United States

  • Decatur Memorial Hospital

    RECRUITING

    Decatur, Illinois, 62526, United States

  • Gundersen Lutheran Medical Center

    RECRUITING

    La Crosse, Wisconsin, 54601, United States

    Contact Email: •••••@•••••

  • Illinois CancerCare - Washington

    RECRUITING

    Washington, Illinois, 61571, United States

  • Illinois CancerCare-Bloomington

    RECRUITING

    Bloomington, Illinois, 61704, United States

  • Illinois CancerCare-Canton

    RECRUITING

    Canton, Illinois, 61520, United States

  • Illinois CancerCare-Carthage

    RECRUITING

    Carthage, Illinois, 62321, United States

  • Illinois CancerCare-Eureka

    RECRUITING

    Eureka, Illinois, 61530, United States

  • Illinois CancerCare-Galesburg

    RECRUITING

    Galesburg, Illinois, 61401, United States

  • Illinois CancerCare-Kewanee Clinic

    RECRUITING

    Kewanee, Illinois, 61443, United States

  • Illinois CancerCare-Macomb

    RECRUITING

    Macomb, Illinois, 61455, United States

  • Illinois CancerCare-Ottawa Clinic

    RECRUITING

    Ottawa, Illinois, 61350, United States

  • Illinois CancerCare-Pekin

    RECRUITING

    Pekin, Illinois, 61554, United States

  • Illinois CancerCare-Peoria

    RECRUITING

    Peoria, Illinois, 61615, United States

  • Illinois CancerCare-Peru

    RECRUITING

    Peru, Illinois, 61354, United States

  • Illinois CancerCare-Princeton

    RECRUITING

    Princeton, Illinois, 61356, United States

  • LSU Health Baton Rouge-North Clinic

    RECRUITING

    Baton Rouge, Louisiana, 70805, United States

    Contact Email: •••••@•••••

  • Roswell Park Cancer Institute

    RECRUITING

    Buffalo, New York, 14263, United States

  • San Juan City Hospital

    RECRUITING

    San Juan, 00936, Puerto Rico

  • Southern Illinois University School of Medicine

    RECRUITING

    Springfield, Illinois, 62702, United States

  • Springfield Clinic

    RECRUITING

    Springfield, Illinois, 62702, United States

  • Springfield Memorial Hospital

    RECRUITING

    Springfield, Illinois, 62781, United States

  • Trinity Health IHA Medical Group Hematology Oncology - Brighton

    RECRUITING

    Brighton, Michigan, 48114, United States

  • Trinity Health IHA Medical Group Hematology Oncology - Canton

    RECRUITING

    Canton, Michigan, 48188, United States

  • Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital

    RECRUITING

    Chelsea, Michigan, 48118, United States

  • Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus

    RECRUITING

    Ypsilanti, Michigan, 48197, United States

  • Trinity Health Saint Joseph Mercy Oakland Hospital

    RECRUITING

    Pontiac, Michigan, 48341, United States

  • Trinity Health Saint Mary Mercy Livonia Hospital

    RECRUITING

    Livonia, Michigan, 48154, United States

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Other studies related to the condition(s) this trial covers.