Decitabine, Venetoclax and Blinatumomab for Maintenance Following HSCT in Patients With Ph-Negative B-ALL

Last updated: November 17, 2024
Sponsor: The First Affiliated Hospital of Soochow University
Overall Status: Active - Recruiting

Phase

2

Condition

Lymphocytic Leukemia, Acute

Leukemia

Treatment

Decitabine, venetoclax and blinatumomab

Clinical Study ID

NCT06393985
FirstSoochowU-DVB
  • Ages 18-65
  • All Genders

Study Summary

This study aims to evaluate whether maintenance therapy with decitabine, venetoclax and blinatumomab could improve the 2-year progression free survival (PFS) of patients with philadelphia chromosome-negative B-cell acute lymphoblastic leukemia who had recently received an allogeneic stem cell transplant and in measurable residual disease-negative remission.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • 1.Philadelphia chromosome-negative B-cell acute lymphoblastic leukemia who underwentan 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 inductionchemotherapy.

  3. patients with detectable minimal residual disease pre-transplantation.

  4. patients in second and higher CR pre-transplantation. 2.Negative minimalresidual 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 ≤ 3x upper limit of normal (ULN), alanine aminotransferase (ALT) ≤ 5 x ULN, aspartateaminotransferase (AST) ≤ 5 x ULN.

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

Exclusion

Exclusion Criteria:

  • 1.Patients with another malignant disease. 2.Patients with uncontrolled activeinfection. 3.Patients with left ventricular ejection fraction < 0.5 byechocardiography or grade III/IV cardiovascular dysfunction according to the NewYork Heart Association Classification.

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

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

Study Design

Total Participants: 30
Treatment Group(s): 1
Primary Treatment: Decitabine, venetoclax and blinatumomab
Phase: 2
Study Start date:
April 25, 2024
Estimated Completion Date:
April 25, 2027

Study Description

This is a phase Ⅱ, open-label, single-arm, multi-center study in patients with philadelphia chromosome-negative B-cell acute lymphoblastic leukemia who had recently received an allogeneic stem cell transplant and in minimal residual disease-negative remission. In this study, patients will be treated with 4 cycles of maintence therapies for up to one year (or until intolerable toxicity, death, withdrawal, or study termination). In cycle one and three, patients will receive decitabine monotherapy, and in cycle two and four, patients will receive a combination of venetoclax and blinatumomab. This study aims to evaluate whether maintenance therapy with decitabine, venetoclax and blinatumomab could improve the 2-year progression free survival (PFS) of those patients, and explore the efficiency and safety.

Connect with a study center

  • The First Affiliated Hospital of Soochow University

    Suzhou, Jiangsu 215006
    China

    Active - Recruiting

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