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Not yet recruitingNCT06075212Updated Oct 10, 2023

Immune Reconstitution After Allo-HSCT and Blinatumomab

An observational study in Leukemia, Lymphoid, sponsored by Sichuan University. Not yet recruiting. Open to participants aged 16 Years to 65 Years. Per ClinicalTrials.gov, last updated 2023-10-10.

Sponsored by Sichuan University · Observational

From the registry’s dates

  • Primary completion was expected by Sep 2024, 2 years ago, but the record still lists the study as not yet recruiting.
Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
20
Ages
16 Years to 65 Years
Sex
All
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Study 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.

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Conditions studied

  • Leukemia, Lymphoid

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03

In context

Leukemia, Lymphoid

1,780 studies on the registry are indexed under Leukemia, Lymphoid; 176 are open to participants now.

This study's planned enrollment of 20 is below the median of 112 across 227 observational studies indexed under Leukemia, Lymphoid.

Browse Leukemia, Lymphoid studies →

Lead sponsor

Sichuan University is the lead sponsor of 106 studies on the registry; 65 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
16 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No
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).

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

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
05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
20 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • 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

  • Drugblinatumomab

    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.

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What researchers measure

Primary outcomes

  1. T cell receptor expression

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

    Time frame: before blinatumomab treatment , 6 months and 1 year

  2. B cell receptor expression

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

    Time frame: before blinatumomab treatment , 6 months and 1 year

Secondary outcomes

  1. T cell subsets count

    T cell subsets count including CD3+, CD4+, CD8+, CD19+, Treg, memory and cytotoxic T cells

    Time frame: before blinatumomab treatment , 6 months and 1 year

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Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 10, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06075212
Lead sponsor
Sichuan University
Responsible party
Jie Ji (Principle Investigator, Sichuan University) — Principal investigator
First posted
Oct 10, 2023
Start date
Oct 1, 2023 (estimated)
Primary completion
Sep 30, 2024 (estimated)
Completion
Sep 30, 2024 (estimated)
Last update
Oct 10, 2023

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Oct 2023. You cannot join it, but the record below documents what was studied.

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