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

A Multicenter, Prospective, Phase II Study of Decitabine, Venetoclax and Blinatumomab for Maintenance Following Allogeneic Hematopoietic Cell Transplantation in Patients With Ph-Negative B-Cell Acute Lymphoblastic Leukemia

This study is testing a combination of three medications to see if they can help people with B-cell acute lymphoblastic leukemia stay in remission after a stem cell transplant.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: The First Affiliated Hospital of Soochow University (Academic / other)
• Drugs / interventions: chemotherapy, blinatumomab
• Locations: 1 site (Suzhou, Jiangsu)
• Trial ID: NCT06393985 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates include patients with Philadelphia chromosome-negative B-ALL who are in minimal residual disease-negative remission and have undergone allogeneic stem cell transplantation.

Not a fit: Patients who are not in remission or have not undergone stem cell transplantation may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly enhance the long-term survival rates for patients with B-ALL following stem cell transplantation.

How similar studies have performed: While similar approaches have been explored, this specific combination of therapies in the context of maintenance after stem cell transplant is relatively novel.

Eligibility criteria

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 this trial is running

Suzhou, Jiangsu

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

Study contacts

• Study coordinator: Xiaowen Tang, Ph.D

Conditions B-cell Acute Lymphoblastic Leukemia; Ph-negative B-ALL; HSCT; maintenance therapy