Immune Reconstitution After Allo-HSCT and Blinatumomab

• Sponsor: Sichuan University (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT06075212
• Collaborator: (none)
• Enrollment: 20
• Anticipated Duration (Months): 12

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Leukemia, Lymphoid	Drug: blinatumomab

Study Design

• Study Type: Observational
• Anticipated Enrollment: 20 participants
• Observational Model: Case-Control
• Time Perspective: Prospective
• Official Title: Immune Reconstitution After Allogeneic Hematopoietic Stem Cell Transplantation With Post-transplant Blinatumomab Maintenance Treatment
• Anticipated Study Start Date: Oct 1, 2023
• Anticipated Primary Completion Date: Sep 30, 2024
• Anticipated Study Completion Date: Sep 30, 2024

Arms and Interventions

Arm	Intervention/Treatment
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.	Drug: 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.
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.	Drug: 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.
Control Patients don't take blinatumomab treatment after transplantation.

Outcome Measures

Primary Outcome Measures

1. T cell receptor expression [before blinatumomab treatment , 6 months and 1 year]

   T cell receptor expression measured by Immune Repertoire sequencing(IR-SEQ)

2. B cell receptor expression [before blinatumomab treatment , 6 months and 1 year]

   B cell receptor expression measured by Immune Repertoire sequencing(IR-SEQ)

Secondary Outcome Measures

1. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 16 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Sichuan University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Jie Ji, Principle Investigator, Sichuan University
• ClinicalTrials.gov Identifier: NCT06075212
• Other Study ID Numbers: Blin-immune 1.0
• First Posted: Oct 10, 2023
• Last Update Posted: Oct 10, 2023
• Last Verified: Oct 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Leukemia, Lymphoid; Blinatumomab

Study Results

No Results Posted as of Oct 10, 2023