RecruitingPhase 1 / Phase 2

Decitabine and Venetoclax Treatment as Maintenance Therapy in Patients Post Allograft Stem Cell Transplant

Phase 1B/2A Study of Weekly Decitabine and Venetoclax Treatment as Maintenance Therapy in High-Risk Myeloid Malignancy Patients Post Allograft Stem Cell Transplant

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Mentioned in the study description

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Pills

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Participants will be administered decitabine once per week with normal transplant follow up visits, and then will take a venetoclax pill about 6 to 8 hours later."
Compensation
Mentioned in the study description
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests low doses of decitabine and venetoclax after a stem cell transplant from a donor. It is for adults with acute myeloid leukemia (AML) or myelodysplastic syndromes (MDS), cancers that affect blood and bone marrow. The goal is to see if this gentler treatment can keep cancer from coming back, help people live longer, and cause fewer side effects.

The goal of this interventional clinical trial is to determine if low doses of gentle chemotherapy after bone marrow transplant may prevent relapse and promote an increase in survival and decrease in side effects in participants with acute myeloid leukemia and myelodysplastic syndromes. The main question it aims to answer is whether or not providing a new, gentler way of administering chemotherapy will help control leftover cancer with minimal side effects. This treatment involves decitabine and venetoclax. Participants will receive standard post-transplant care. Participants will be administered decitabine once per week with normal transplant follow up visits, and then will take a venetoclax pill about 6 to 8 hours later. Participants will meet their study team at the beginning, midway, and at the end of the trial to receive bone marrow testing. Participants will receive treatment until either one year of therapy, relapse, or recurrent dose limiting toxicity (DLT) despite dose reduction.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be age 18 or older, with AML, MDS, or MDS/AML, and need or have had a stem cell transplant from a donor.
  • Before transplant, have fewer than 5% blasts (immature blood cells) in bone marrow and none in blood for AML or MDS/AML. For MDS, have fewer than 10% blasts in bone marrow.
  • Join before transplant or no later than 40 days after transplant.
  • Meet liver and kidney test limits: bilirubin below 2.0 mg/dL and creatinine clearance above 30 mL/min. A different bilirubin limit applies to people with Gilbert's syndrome.
  • Meet activity and self-care score limits: ECOG 0–1 or KPS 70 or higher.
  • Be able to understand and sign the consent form and complete study tasks.
  • By day 50 after transplant, have neutrophils (infection-fighting cells) of at least 500/uL and platelets (cells that help stop bleeding) of at least 50,000/uL for 3 days in a row.
  • Before study treatment, have no active infection, fewer than 5% bone marrow blasts, and no grade 2 or higher graft-versus-host disease (when donor cells attack your body). Still meet the other entry rules.

Who can't join

  • Have another planned treatment to keep cancer from coming back after transplant.
  • Be pregnant or breastfeeding. People who can become pregnant must have a negative blood pregnancy test within 72 hours before treatment starts.
  • Have an uncontrolled illness that could shorten life or prevent study tasks, such as an active infection, uncontrolled cancer, severe heart failure, unstable chest pain or heartbeat, or severe liver disease.
  • Have a mental health condition, social situation, or other condition that could make study participation unsafe or make it hard to follow study rules or judge results.
  • Be unwilling to follow the required use of two birth control methods before joining and during the study, if you can become pregnant or are male.
  • Be a sexually active male unwilling to use a condom with a female who can become pregnant, from screening until 4 weeks after the last dose.
  • Have known active HIV. People with chronic HIV may join if the virus cannot be detected, they have no infections linked to a weak immune system, and their HIV treatment is stable.
  • Have a known allergy to any part of decitabine or venetoclax.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * Diagnosis of Acute myeloid leukemia, MDS, MDS/AML who requires and allogeneic stem cell transplant. * For AML and MDS/AML, bone marrow myeloblasts \<5% at pre-transplant bone marrow sample with no circulating blasts. For MDS patients, pre-transplant bone marrow myeloblasts \< 10% * Participants must be planned for or have received alloSCT. Any conditioning regimen intensity or graft source (MRD/MUD/Haplo/UCB) is permitted. * Participants must be 18 years of age or older. * Total bilirubin \< 2.0 mg/dL (with the exception of participants with known Gilbert's syndrome, who should have direct bilirubin \< 2 × ULN). * Creatinine clearance (CrCl) \> 30 ml/min. * ECOG 0-1 or KPS equal or greater than 70 performance status * Subjects must have the ability to understand and the willingness to sign a written informed consent document and complete study related procedures. * Patients may enroll prior to or after allo SCT. Patients should enroll no later than post transplant day 40, and the the following post-Allo HSCT inclusion criteria must be met in order to initiate the maintenance study treatment: * Successful engraftment defined by absolute neutrophil count (ANC) of ≥500/ul and platelet count of ≥50,000/uL sustained for at least three consecutive days * These criteria for engraftment should be met on or before Day +50. * No active infection * No GVHD ≥ overall grade II (Grade 1 GVHD of the skin acceptable). * Participants must continue to meet additional inclusion criteria * \<5% myeloblasts in a bone marrow aspirate with spicules, that is to be obtained, if all the above inclusion criteria are satisfied. Exclusion Criteria: * Other planned post-transplant maintenance therapy, such as FLT3-ITD targeting agents, as determined by the treating physician * Currently pregnant or breast-feeding. Females of childbearing (FOCBP) potential must have negative serum pregnancy test within 72 hours from treatment start. (NOTE: FOCBP is any biologic female, regardless of sexual or gender orientation, having undergone tubal ligation, or remaining celibate by choice, who has not undergone a documented hysterectomy or bilateral oophorectomy or has had a menses any time in the preceding 12 months (therefore not naturally post-menopausal for \> 12 months) * Uncontrolled comorbid illness that could limit life expectancy or ability to complete study correlates. This includes, but is not limited to: * Active infection * Uncontrolled concurrent malignancy * Congestive heart failure of NYHA class III/IV. Participants with compensated heart failure are permitted. * Unstable angina pectoris * New or unstable cardiac arrhythmia. Stable or controlled arrhythmias are permitted * Decompensated liver cirrhosis (Child-Pugh score ≥12 or a MELD score ≥21 * Psychiatric illness/social situations that would limit compliance with study requirements. * Any other prior or ongoing condition, in the opinion of the investigator, that could adversely affect the safety of the participants or impair the assessment of study results. * FOCBP and males that are unwilling to agree to use dual contraceptive measures (i.e., hormonal or barrier method of birth control; abstinence, condom) prior to study entry and for the duration of study participation. Should a female subject become pregnant or suspect she is pregnant while participating in this study, they should inform the treating physician immediately * Sexually active male who is unwilling to use a condom when engaging in any sexual contact with a female with child-bearing potential, beginning at the screening visit and continuing until 4 weeks after taking the last dose of decitabine/venetoclax. * Participants with known active HIV infection, as this will further increase the risk for opportunistic infections. However, participants with chronic HIV with undetectable viral load by PCR, without opportunistic infection, and on a stable regimen of antiretroviral therapy would be eligible. * Known allergy or hypersensitivity to any component of decitabine/venetoclax

Study sites (2)

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