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

Recruiting now · Phase 2

Conditions studied: B-cell Acute Lymphoblastic Leukemia

In brief

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.

Key facts

Study ID

NCT06393985

Run by

The First Affiliated Hospital of Soochow University

People needed

30

Starts

2024-04-25

Expected to finish

2027-04-25

Last updated by the study team

2024-11-19

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 1.Philadelphia chromosome-negative B-cell acute lymphoblastic leukemia who underwent an alloHSCT as follows:
• patients in CR1 with high-risk features,including adverse clinical features, cytogenetic or molecular alterations according to NCCN 2023.V3.
• patients lack of achievement of complete remission after standard induction chemotherapy.
• patients with detectable minimal residual disease pre-transplantation.
• 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 months post-transplantation. 4.hematopoietic reconstitution, i.e., ANC ≥0.5 x 109/L, and platelets >20 x 109/L.
• 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.
• Creatinine clearance ≥ 30 mL/min. 8.Provide informed consent.

You may not qualify if…

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

Where it is running

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

Full record on ClinicalTrials.gov

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