Immune Reconstitution After Allo-HSCT and Blinatumomab

NCT ID: NCT06075212

Last Updated: 2023-10-10

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 20 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-10-01
• Study Completion Date: 2024-09-30

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 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.

Conditions

Leukemia, Lymphoid

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Blin-PTCY

Post-transplant cyclophosphamide is used as graft versus host disease (GvHD) prophylaxis. Treatment with blinatumomab was initiated within 60 to 90 days after transplantation and was administered bimonthly until 1 year after transplantation.

blinatumomab

Intervention Type: DRUG

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.

Blin-ATG

Antithymocyte globulin is used as graft versus host disease (GvHD) prophylaxis. Treatment with blinatumomab was initiated within 60 to 90 days after transplantation and was administered bimonthly until 1 year after transplantation.

blinatumomab

Intervention Type: DRUG

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.

Control

Patients don't take blinatumomab treatment after transplantation.

No interventions assigned to this group

Interventions

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. 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.

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sichuan University

OTHER

Sponsor Role: lead

Responsible Party

Jie Ji

Principle Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

Blin-immune 1.0

Identifier Type: -

Identifier Source: org_study_id