Immune Reconstitution After Allo-HSCT and Blinatumomab

Not yet recruiting

• Conditions: Leukemia, Lymphoid
• Interventions: Drug: blinatumomab

• Registration Number: NCT06075212
• Lead Sponsor: Sichuan University

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-10
• Study Start: 2023-10-01
• Study First Submitted: 2023-10-03
• Study First Submitted QC: 2023-10-03
• Last Update Submitted: 2023-10-03
• Study First Posted: 2023-10-10
• Last Update Posted: 2023-10-10
• Primary Completion: 2024-09-30
• Study Completion: 2024-09-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Blin-PTCY	blinatumomab	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.
Blin-ATG	blinatumomab	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.

Primary Outcome Measures

Name	Time	Method
B cell receptor expression	before blinatumomab treatment , 6 months and 1 year	B cell receptor expression measured by Immune Repertoire sequencing(IR-SEQ)
T cell receptor expression	before blinatumomab treatment , 6 months and 1 year	T cell receptor expression measured by Immune Repertoire sequencing(IR-SEQ)

Secondary Outcome Measures

Name	Time	Method
T cell subsets count	before blinatumomab treatment , 6 months and 1 year	T cell subsets count including CD3+, CD4+, CD8+, CD19+, Treg, memory and cytotoxic T cells