Status:
NOT_YET_RECRUITING
Blinatumomab Prevents Recurrence of R/R ALL After Allo-HSCT
Lead Sponsor:
Sichuan University
Conditions:
Leukemia, Lymphoid
Eligibility:
All Genders
16-65 years
Phase:
PHASE2
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)....
Eligibility Criteria
Inclusion
- 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;
- Complete remission (CR) after allo-HSCT with either myeloablative or non-myeloablative conditioning regimen determined by the investigator;
- Reach the standard of hematopoietic reconstitution (neutrophil count
- ≥ 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;
- No central nervous system involvement or clinical symptoms after transplantation;
- Those who have no serious functional damage to important organs of the body;
- Fully understand and be informed of this study and sign the ICF; willing to follow and have the ability to complete all test procedures;
- 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
- 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;
- Combined with other malignant tumors and require treatment;
- Active GVHD;
- Have a history of allergy to Chidamide;
- Pregnant or lactating females;
- Patients with known history of human immunodeficiency virus (HIV) virus infection and/or acquired immunodeficiency syndrome;
- Patients with active chronic hepatitis B or active hepatitis C;
- History of prolonged QT syndrome;
- Patients considered by other researchers to be unsuitable for this study
Key Trial Info
Start Date :
October 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 30 2026
Estimated Enrollment :
68 Patients enrolled
Trial Details
Trial ID
NCT06075238
Start Date
October 1 2023
End Date
September 30 2026
Last Update
October 10 2023
Active Locations (1)
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1
West China Hospital of Sichuan University
Chengdu, Sichuan, China, 610044