Last Updated: June 3, 2024 Notice- Information is sourced from public registries and may not reflect real-time changes at the local site.
To evaluate the safety and efficacy of Blinatumomab maintenance after allogeneic hematopoietic stem cell transplantation for high-risk acute B-lymphoblastic leukemia.
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Treatment Category
Drug
Required Mutations
None
Trial Started
July 1, 2024
Last Updated by Sponsor
June 3, 2024
Estimated Completion
July 1, 2026
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Eligibility
Inclusion Criteria
1. Age 16-65 years
2. Diagnosis with acute B-lymphoblastic leukemia (B-ALL) expressed CD19
3. High-risk group B-ALL
4. Have suitable hematopoietic stem cell donors
5. No dysfunction of vital organs
Exclusion Criteria
1. CR/MRD negative before blinatumomab maintenance
2. Active hepatitis B
3. HIV-infected
4. Active infections; acute and chronic GVHD requiring systemic immunosuppressive therapy;
5. severe impairment of vital organ function
6. Those judged by the investigator to be unsuitable for participation in this trial.
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Design Details
AllocationRandomized
Intervention ModelParallel Assignment
MaskingNone (Open Label)
Number to Enroll59
Arms & Interventions
Arms
Interventions
Type: Experimental
Description: Blinatumomab group (Blinatumomab): 9 μg/d intravenously over 24 hours until the end of d14 days of dosing. Repeat every 3 months for a total of 4 courses. (Basis for Dose Selection: The recommended dose of blinatumomab for MRD-negative patients is 9ug/d)
Interventions:
Blinatumomab
Outcome Measures
Primary Outcome Measures
2-year Event-free survivalthrough study completion, an average of 2 year
Secondary Outcome Measures
2-year relapse ratethrough study completion, an average of 2 year