Blinatumomab Prevents Recurrence of R/R ALL After Allo-HSCT
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 2 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: blinatumomab 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. |
Drug: blinatumomab
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.
|
Outcome Measures
Primary Outcome Measures
- Progression free survival (PFS) [2 years]
Progression free survival of this group of patients at the end of 2 year
- 100 day adverse events (AE) [Day +100]
non-hematologic adverse events
Secondary Outcome Measures
- Non-relapse mortality (NRM) [6 months]
Non-relapse mortality of this group of patients at the end of 6 month
- Relapse rate [2 years]
Relapse rate of this group of patients at the end of 2 year
- Overall survival (OS) [2 years]
Overall survival of this group of patients at the end of 2 year
- Cumulative incidence of acute graft versus host disease (aGVHD) [Day +100]
Cumulative incidence of acute graft versus host disease (aGVHD) of this group of patients at day+100
- Cumulative incidence of chronic graft versus host disease (cGVHD) [2 years]
Cumulative incidence of chronic graft versus host disease (cGVHD) of this group of patients at the end of 2 year
Eligibility Criteria
Criteria
Inclusion Criteria:
-
B-ALL patients with history of relapse, or MRD positive in the last bone marrow examination before allo-HSCT;
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Age ≥16 years old and ≤ 65 years old when signing informed consent Form (ICF);
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KPS > 60 or ECOG 0-2;
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The expected survival time is more than 3 months;
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Complete remission (CR) after allo-HSCT with either myeloablative or non-myeloablative conditioning regimen determined by the investigator;
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Reach the standard of hematopoietic reconstitution (neutrophil count
≥ 0.5×109/L for 3 consecutive days without G-CSF application, platelet count ≥ 20×109/L for 7 consecutive days without platelet transfusion, Hb ≥ 80 g /L without red blood cell transfusion); and neutrophil count ≥ 1.5×109/L, platelet count ≥ 50×109/L within 45 days after transplantation;
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No central nervous system involvement or clinical symptoms after transplantation;
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Those who have no serious functional damage to important organs of the body;
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Fully understand and be informed of this study and sign the ICF; willing to follow and have the ability to complete all test procedures;
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Females of childbearing age must afford a serum pregnancy test within 7 days before the first dose, and the result should be negative; female participants and their partners should agree to use effective contraception from signing the ICF until 6 months after the last dose.
Exclusion Criteria:
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Serious basic diseases of important organs: such as myocardial infarction, chronic cardiac insufficiency, decompensated hepatic insufficiency, renal function, gastrointestinal insufficiency, etc.;
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Uncontrolled active infection (including bacterial, fungal, or viral infection), and drug treatment is ineffective;
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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;
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Poor graft function (PGF) occurred after allo-HSCT;
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Combined with other malignant tumors and require treatment;
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Active GVHD;
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Have a history of allergy to Chidamide;
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Pregnant or lactating females;
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Patients with known history of human immunodeficiency virus (HIV) virus infection and/or acquired immunodeficiency syndrome;
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Patients with active chronic hepatitis B or active hepatitis C;
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History of prolonged QT syndrome;
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Patients considered by other researchers to be unsuitable for this study
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | West China Hospital of Sichuan University | Chengdu | Sichuan | China | 610044 |
Sponsors and Collaborators
- Sichuan University
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- PT-Blin 1.0