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

Sponsor
The First Affiliated Hospital of Soochow University
Study ID
NCT06393985
Phase
PHASE2
Status
Recruiting
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Conditions

  • B-cell Acute Lymphoblastic Leukemia

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Decitabine, venetoclax and blinatumomab — DRUG
    Cycle1 and cycle3： Decitabine monotherapy,20 mg/m2 qd, d1-5,intravenous infusion; Cycle2 and cycle4: Venetoclax 200mg qd, d1-14, orally; Blinatumomab d4-17(Weight ≥45 kg, 9ug d4-6, 28ug d7-17; Weight \<45 kg, 5ug/m2 d4-6, 15ug/m2 d7-17;continuous intravenous infusion)

Study Details

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 Dates

Start date
Apr 25, 2024
Status verified
Apr 2024
Primary completion
Apr 25, 2026
Completion
Apr 25, 2027

Study Design

Enrollment
30 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Decitabine,venetoclax and blinatumomab

Primary Outcome Measure

PFS [ Time Frame: From date of allogenetic HSCT until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 years after allogenetic HSCT ]

Central Contacts

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