Study on Decitabine and Venetoclax as Maintenance Therapy After Stem Cell Transplant for Blood Cancer Patients

Sponsor: Benjamin Tomlinson

Sponsor score: 0

ClinicalTrials ID:NCT06129734

Provider View

This clinical trial is exploring whether a gentler form of chemotherapy, using decitabine and venetoclax, can help prevent cancer from returning and improve survival in patients with acute myeloid leukemia or myelodysplastic syndromes after a bone marrow transplant.

Patient Parameters

Program Overview

The aim of this study is to find out if using low doses of chemotherapy drugs, decitabine and venetoclax, after a bone marrow transplant can help prevent cancer from coming back and improve survival rates in patients with acute myeloid leukemia (AML) or myelodysplastic syndromes (MDS). Participants will receive standard care after their transplant and will take decitabine once a week, followed by a venetoclax pill 6 to 8 hours later. The study will monitor participants through regular follow-up visits and bone marrow tests at the start, middle, and end of the trial. Treatment will continue for up to one year, unless the cancer returns or side effects become too severe.

Description

Acute myeloid leukemia (AML) is a common type of blood cancer in adults. While many patients can initially achieve remission, the cancer often returns, especially after a bone marrow transplant. This study is testing a new maintenance therapy using low-intensity chemotherapy to prevent relapse. The treatment combines decitabine and venetoclax, which have shown promise in managing AML by targeting cancer cells while minimizing harm to healthy cells. The study aims to determine if this approach can effectively control the disease with fewer side effects. Participants will receive decitabine weekly and a single dose of venetoclax shortly after, with the goal of maximizing the treatment's effectiveness while reducing toxicity. This regimen could offer a new option for maintaining remission after a transplant.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with acute myeloid leukemia (AML) or myelodysplastic syndromes (MDS) with a high risk of relapse after transplant.
  • Bone marrow tests show less than 5% cancer cells before transplant.
  • Planned for or have received a bone marrow transplant.
  • Aged 18 years or older.
  • Good liver and kidney function as shown by specific blood tests.
  • Good overall health with a performance status score of 0 or 1.
  • Able to understand and sign a consent form and complete study procedures.
  • Enroll before or shortly after transplant, meeting specific health criteria.
  • Successful engraftment after transplant, with stable blood counts and no active infections.
  • No severe graft-versus-host disease (GVHD) or other complications.

Exclusion Criteria

  • Previous progression on similar treatments (HMA/VEN therapy).
  • Other planned maintenance therapies after transplant.
  • Currently pregnant or breastfeeding.
  • Serious health conditions that could affect life expectancy or study participation.
  • Uncontrolled infections or other active cancers.
  • Severe heart conditions or unstable heart rhythms.
  • Severe liver disease.
  • Mental health or social issues affecting study compliance.
  • Not willing to use effective birth control during the study.
  • Active HIV infection, unless well-controlled with treatment.
  • Known allergy to study medications.

Locations

FACILITYZIPCITYSTATE
University Hospitals Seidman Cancer, Case Comprehensive Cancer Center44106ClevelandOhio

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