Blinatumomab Prevents Recurrence of R/R ALL After Allo-HSCT

StatusUnknown
PhasePhase 2
Started

Record status This record was last updated October 10, 2023 (before its estimated September 30, 2024 completion). Its status may not reflect the trial's current state.

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Record History

  1. Changed Registry marked status Unknown (sponsor has not verified the record since Oct 2023); last known: Not Yet Recruiting
  2. Study First Submitted
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Sichuan University
63 trials monitored
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Leukemia
2,957 trials monitored
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The goal of this phase I/II clinical trial is to test in relapsed or refractory acute lymphoblastic leukemia (R/R ALL) patients undergoing allogeneic hemopoietic stem-cell transplantation (allo-HSCT). The main question it aims to answer is: • The efficacy and safety of blinatumomab maintenance therapy in reducing the recurrence rate a in R/R ALL patients after allo-HSCT. Participants will take intravenous blinatumomab after allo-HSCT. The dose of one course was as follows: day 1-2: 8ug/day, continuous intravenous drip for 24 hours, day 3-7: 16ug/day, continuous intravenous drip for 24 hours. Treatment with blinatumomab was initiated within 60 to 90 days after transplantation and was administered bimonthly until 1 year after transplantation. Dexamethasone 20mg was administered 1 hour before administration on days 1 and 3 to prevent adverse events.
Trial Details
NCT Number NCT06075238
Lead Sponsor Sichuan University
Conditions
(from sponsor)		 Leukemia, Lymphoid
Related terms Leukemia, Lymphoid
Enrollment 68 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov