West China Hospital of Sichuan University
Chengdu, Sichuan, 610044, China
NCT Number: NCT06075238
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 opening soon.
Get Notified16 year–65 year
All sexes
Interventional
Phase 2
Chengdu, Sichuan, 610044, China
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
≥ 0.5×10^9/L for 3 consecutive days without G-CSF application, platelet count ≥ 20×10^9/L for 7 consecutive days without platelet transfusion, Hb ≥ 80 g /L without red blood cell transfusion); and neutrophil count ≥ 1.5×10^9/L, platelet count ≥ 50×10^9/L within 45 days after transplantation;
Exclusion criteria
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. Dexamethasone 20mg was administered 1 hour before administration on days 1 and 3 to prevent adverse events.
Time frame: 2 years
Progression free survival of this group of patients at the end of 2 year
Time frame: Day +100
non-hematologic adverse events
Time frame: 6 months
Non-relapse mortality of this group of patients at the end of 6 month
Time frame: 2 years
Relapse rate of this group of patients at the end of 2 year
Time frame: 2 years
Overall survival of this group of patients at the end of 2 year
Time frame: Day +100
Cumulative incidence of acute graft versus host disease (aGVHD) of this group of patients at day+100
Time frame: 2 years
Cumulative incidence of chronic graft versus host disease (cGVHD) of this group of patients at the end of 2 year
Contact information is provided by the study sponsor or research team.
Sichuan University
Other
Blinatumomab Prevents the Recurrence of Relapsed or Refractory Acute Lymphoblastic Leukemia After Allogeneic Hematopoietic Stem-cell Transplantation: A Prospective, Singlecentered, Single-arm, Phase II Clinical Study
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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