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
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Ages | Any age to 65 Years |
| Sex | All |
| Enrollment | 60 (estimated) |
| Sponsor | The First Affiliated Hospital of Zhengzhou University Academic / other |
| Drugs / interventions | Blinatumomab |
| Locations | 1 site (Zhenzhou, Henan) |
| Status | Recruiting |
| Started | September 1, 2023 |
| Main results expected | December 31, 2026 |
| Study ends | June 30, 2027 |
| Registry record updated | April 1, 2024 |
| Trial ID | NCT06339775 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
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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.
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Blinatumomab plus low-dose donor cells after transplant for high-risk B-ALL
This small, early-phase study tests whether giving blinatumomab with low-dose donor lymphocytes after allogeneic transplant is safe and helps long-term survival for people with high-risk B-ALL.
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LP-118 in combination with standard therapy for newly diagnosed Ph+ ALL
This study tests whether adding LP-118 to the standard therapy for adults with Philadelphia chromosome–positive ALL is safe and useful.
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MK-1045 versus blinatumomab for relapsed or refractory CD19-positive B-cell acute lymphoblastic leukemia
This trial will test whether MK-1045 helps people with relapsed or refractory CD19-positive B-cell acute lymphoblastic leukemia more than the standard immunotherapy blinatumomab.
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Vaccine protection after blinatumomab in children with B-ALL
This project will see if children and young adults (ages 1–21) with B-cell acute lymphoblastic leukemia who received blinatumomab keep protective immunity from routine childhood vaccines and whether revaccination restores immunity when levels are low.
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Asciminib in children and young adults with relapsed or refractory Ph+ or ABL-class Ph-like ALL
This study tests asciminib in kids and young adults with relapsed or refractory Philadelphia-positive or ABL-class Ph-like ALL to see if it is safe and helps treat the leukemia.
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Subcutaneous blinatumomab treatment for adults with CD19-positive mixed phenotype acute leukemia
This trial tests whether giving blinatumomab under the skin can help adults with CD19-positive mixed phenotype acute leukemia, including older or unfit newly diagnosed patients, those with measurable residual disease after remission, and those with relapsed or refractory disease.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.