Using decitabine, venetoclax, and blinatumomab for maintenance therapy in B-ALL patients after stem cell transplant

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase 2, open-label, single-arm, multi-center study evaluates the effectiveness of maintenance therapy with decitabine, venetoclax, and blinatumomab in patients with Philadelphia chromosome-negative B-cell acute lymphoblastic leukemia (B-ALL) who have recently undergone allogeneic stem cell transplantation and are in measurable residual disease-negative remission. Patients will receive four cycles of treatment over the course of one year, alternating between decitabine monotherapy and a combination of venetoclax and blinatumomab. The primary goal is to assess whether this regimen can improve the two-year progression-free survival rate in this patient population.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 1.Philadelphia chromosome-negative B-cell acute lymphoblastic leukemia who underwent an alloHSCT as follows:

  1. patients in CR1 with high-risk features,including adverse clinical features, cytogenetic or molecular alterations according to NCCN 2023.V3.
  2. patients lack of achievement of complete remission after standard induction chemotherapy.
  3. patients with detectable minimal residual disease pre-transplantation.
  4. patients in second and higher CR pre-transplantation. 2.Negative minimal residual disease prior to enrollment (FCM-MRD \<0.01% and fusion gene negative).

  3.≥3 months post-transplantation. 4.hematopoietic reconstitution, i.e., ANC ≥0.5 x 109/L, and platelets \>20 x 109/L.

  5.Eastern Cooperative Oncology Group (ECOG) score: 0-2. 6.Total serum bilirubin ≤ 3 x upper limit of normal (ULN), alanine aminotransferase (ALT) ≤ 5 x ULN, aspartate aminotransferase (AST) ≤ 5 x ULN.

  7.Creatinine clearance ≥ 30 mL/min. 8.Provide informed consent.

Exclusion Criteria:

* 1.Patients with another malignant disease. 2.Patients with uncontrolled active infection. 3.Patients with left ventricular ejection fraction \< 0.5 by echocardiography or grade III/IV cardiovascular dysfunction according to the New York Heart Association Classification.

  4.Detectable minimal residual disease post-transplantation 5.Active GVHD requiring systemic steroid therapy. 6.Patients with uncontrolled active bleeding. 7.Pregnant and lactating women; patients of childbearing potential should be willing to practice methods of contraception throughout the study period.

  8.Patients with other commodities that the investigators considered not suitable for the enrollment.

Where it's running

• The First Affiliated Hospital of Soochow University
  Suzhou, Jiangsu, China Recruiting

Study contacts

• Study coordinator: Xiaowen Tang, Ph.D
• Email: xwtang1020@163.com
• Phone: 67781525

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.