Clinical trial Recruiting at 1 site Phase 4 Interventional Ages Any age to 65

Using Blinatumomab for treating relapsed Acute B-cell Lymphoblastic Leukemia after transplantation

Official title: Blinatumomab Sequential Donor Lymphocyte Infusion in Acute B Lymphocytic Leukemia Observation of Therapeutic Effect in Patients With Recurrence After Allogeneic Hematopoietic Stem Cell Transplantation

Run by The First Affiliated Hospital of Zhengzhou University · NCT06339775 · Data updated 2026-11-12

This study is testing if a new treatment called Blinatumomab can help younger patients with relapsed Acute B-cell Lymphoblastic Leukemia feel better after a stem cell transplant.

Quick facts

PhasePhase 4
Study typeInterventional
AgesAny age to 65 Years
SexAll
Enrollment60 (estimated)
SponsorThe First Affiliated Hospital of Zhengzhou University
Academic / other
Drugs / interventionsBlinatumomab
Locations1 site (Zhenzhou, Henan)
StatusRecruiting
StartedSeptember 1, 2023
Main results expectedDecember 31, 2026
Study endsJune 30, 2027
Registry record updatedApril 1, 2024
Trial IDNCT06339775 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are patients aged 65 years or younger with stable vital signs and no severe infections or organ failures.

Probably not a fit

Patients over 65 years old or those with severe infections, organ failures, or central nervous system leukemia may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the efficacy and safety of Blinatumomab in patients with relapsed Acute B-cell Lymphoblastic Leukemia (B-ALL) following allogeneic hematopoietic stem cell transplantation. Patients who experience a relapse will receive Blinatumomab treatment, followed by donor lymphocyte infusion (DLI) to enhance the anti-leukemic effect. The study aims to analyze the outcomes and side effects associated with this sequential treatment approach. Enrollment is open for patients aged 65 and younger who meet specific health criteria.

Why it matters

Potential benefit: If successful, this treatment could improve survival rates and outcomes for patients with relapsed B-ALL after transplantation.

How similar studies have gone: Similar studies have shown promise in using Blinatumomab for treating relapsed B-ALL, indicating potential for success in this approach.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

1. Age ≤65 years old
2. Stable vital signs
3. No severe infection
4. There was no grade II-IV graft-versus-host disease
5. No organ failure

Exclusion Criteria:

1. Age \> 65 years old
2. Unstable vital signs
3. Complicated with severe infection
4. Combined with grade Ⅱ-Ⅳ graft-versus-host disease
5. Heart, liver, kidney and other organ failure
6. Complicated with central nervous system leukemia
7. Allergies to medications in the treatment regimen

Where it's running

  • The First Affiliated Hospital of Zhengzhou University
    Zhenzhou, Henan, China
    Recruiting

Study contacts

  • Principal investigator: Zhilei BIAN — The First Affiliated Hospital of Zhengzhou University
  • Study coordinator: Suping ZHANG
  • Email: zsp198612@163.com
  • Phone: +8613523510641

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.