Status:
UNKNOWN
Immune Reconstitution After Allo-HSCT and Blinatumomab
Lead Sponsor:
Sichuan University
Conditions:
Leukemia, Lymphoid
Eligibility:
All Genders
16-65 years
Brief Summary
The goal of this observation study is to test in relapsed or refractory acute lymphoblastic leukemia (R/R ALL) patients undergoing allogeneic hemopoietic stem-cell transplantation (allo-HSCT). The mai...
Eligibility Criteria
Inclusion
- Aged 16-65 years old
- KPS score \> 60 or ECOG score 0-2
- diagnosed as B-ALL, a) disease status \> CR1 at the time of transplantation; Patients beyond CR1 or induction failure could be free of minimal residual disease (MRD). b) any residual disease, defined as \>0.01% leukemic cells by flow cytometry, BCR-ABL transcript ≥ 1 in 10000 by PCR, or high-risk genetic abnormality
- neutrophil count ≥0.5×10\^9/L and platelet count ≥20×10\^9/L
- creatinine clearance ≥30ml/min; Alanine aminotransferase/aspartate aminotransferase ≤5 times the upper detection limit; Total bilirubin ≤3 times the upper limit of detection
- The first initiation of berintuzumab therapy was within 60-100 days after transplantation
- without evidence of active acute graft-versus-host disease (aGvHD)
Exclusion
- With serious basic diseases of important organs, such as myocardial infarction, chronic cardiac insufficiency, decompensated liver dysfunction, renal dysfunction, gastrointestinal dysfunction, etc
- With clinically uncontrolled active infection
- Patients with central nervous system involvement before transplantation
- Poor graft function (PGF) occurred after allo-HSCT
- Patients with second allogeneic transplantation
Key Trial Info
Start Date :
October 1 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
September 30 2024
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT06075212
Start Date
October 1 2023
End Date
September 30 2024
Last Update
October 10 2023
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