Using Blinatumomab for treating relapsed Acute B-cell Lymphoblastic Leukemia after transplantation
Blinatumomab Sequential Donor Lymphocyte Infusion in Acute B Lymphocytic Leukemia Observation of Therapeutic Effect in Patients With Recurrence After Allogeneic Hematopoietic Stem Cell Transplantation
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 |
| Enrollment | 60 (estimated) |
| Ages | N/A to 65 Years |
| Sex | All |
| Sponsor | The First Affiliated Hospital of Zhengzhou University Academic / other |
| Drugs / interventions | Blinatumomab |
| Locations | 1 site (Zhenzhou, Henan) |
| Trial ID | NCT06339775 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are patients aged 65 years or younger with stable vital signs and no severe infections or organ failures.
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.
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 performed: Similar studies have shown promise in using Blinatumomab for treating relapsed B-ALL, indicating potential for success in this approach.
Eligibility criteria
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 this trial is running
Zhenzhou, Henan
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.