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Trial Title:
Immune Reconstitution After Allo-HSCT and Blinatumomab
NCT ID:
NCT06075212
Condition:
Leukemia, Lymphoid
Conditions: Official terms:
Leukemia, Lymphoid
Blinatumomab
Study type:
Observational
Overall status:
Not yet recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Drug
Intervention name:
blinatumomab
Description:
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.
Arm group label:
Blin-ATG
Arm group label:
Blin-PTCY
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 main question it aims to answer is:
• Effect of post-transplant blinatumomab treatment on immune reconstitution after
transplantation.
Participants will undergo immune repertoire sequencing(IR-SEQ) before blinatumomab
treatment, 6 months and 1 year after transplantation.
Researchers will compare patients who don't receive blinatumomab treatment after
transplantation to see if TCR or BCR expression differs.
Criteria for eligibility:
Study pop:
Relapsed or refractory acute lymphoblastic leukemia (R/R ALL) patients undergoing
allogeneic hemopoietic stem-cell transplantation (allo-HSCT).
Sampling method:
Non-Probability Sample
Criteria:
Inclusion Criteria:
1. Aged 16-65 years old
2. KPS score > 60 or ECOG score 0-2
3. 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
4. neutrophil count ≥0.5×10^9/L and platelet count ≥20×10^9/L
5. creatinine clearance ≥30ml/min; Alanine aminotransferase/aspartate aminotransferase
≤5 times the upper detection limit; Total bilirubin ≤3 times the upper limit of
detection
6. The first initiation of berintuzumab therapy was within 60-100 days after
transplantation
7. without evidence of active acute graft-versus-host disease (aGvHD)
Exclusion Criteria:
1. With serious basic diseases of important organs, such as myocardial infarction,
chronic cardiac insufficiency, decompensated liver dysfunction, renal dysfunction,
gastrointestinal dysfunction, etc
2. With clinically uncontrolled active infection
3. Patients with central nervous system involvement before transplantation
4. Poor graft function (PGF) occurred after allo-HSCT
5. Patients with second allogeneic transplantation
Gender:
All
Minimum age:
16 Years
Maximum age:
65 Years
Healthy volunteers:
No
Start date:
October 1, 2023
Completion date:
September 30, 2024
Lead sponsor:
Agency:
Sichuan University
Agency class:
Other
Source:
Sichuan University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06075212
