Blinatumomab Prevents Recurrence of R/R ALL After Allo-HSCT
ConditionLeukemia, Lymphoid
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age16-65
SponsorSichuan University
About this trial
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.
Eligibility criteria
Qualifiers
B-ALL patients with history of relapse, or MRD positive in the last bone marrow examination before allo-HSCT;
Age ≥16 years old and ≤ 65 years old when signing informed consent Form (ICF);
KPS > 60 or ECOG 0-2;
The expected survival time is more than 3 months;
Disqualifiers
Serious basic diseases of important organs: such as myocardial infarction, chronic cardiac insufficiency, decompensated hepatic insufficiency, renal function, gastrointestinal insufficiency, etc.;
Uncontrolled active infection (including bacterial, fungal, or viral infection), and drug treatment is ineffective;
Participating in other clinical studies, or planning to start treatment in this study and less than 4 weeks before the end of treatment in the previous clinical study;
Poor graft function (PGF) occurred after allo-HSCT;
Trial design
Treatments tested in this trial
- blinatumomab
Treatment groups
68 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov