Immune Reconstitution After Allo-HSCT and Blinatumomab

NCT06075212 | Unknown

• 1 other identifier: Blin-immune 1.0
• Study Type: observational
• Target: 20
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (2)

• T cell receptor expression

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

  before blinatumomab treatment , 6 months and 1 year

• B cell receptor expression

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

  before blinatumomab treatment , 6 months and 1 year

Secondary Outcomes (1)

• T cell subsets count

  before blinatumomab treatment , 6 months and 1 year

Study Arms (3)

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

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

Control

Patients don't take blinatumomab treatment after transplantation.

Interventions

blinatumomab 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; Blin-PTCY

Eligibility Criteria

• Age: 16 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Relapsed or refractory acute lymphoblastic leukemia (R/R ALL) patients undergoing allogeneic hemopoietic stem-cell transplantation (allo-HSCT).

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Sichuan University: lead

Biospecimen

Retention: SAMPLES WITH DNA

peripheral blood

MeSH Terms

Conditions

Leukemia, Lymphoid

Interventions

blinatumomab

Condition Hierarchy (Ancestors)

Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: October 3, 2023
• First Posted: October 10, 2023
• Study Start: October 1, 2023
• Primary Completion: September 30, 2024
• Study Completion: September 30, 2024
• Last Updated: October 10, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share