Using blinatumomab to prepare patients for stem cell transplants in low-burden B-ALL
Short-term Blinatumomab as a Bridge Therapy for Hematopoietic Stem Cell Transplantation in B-cell Acute Lymphoblastic Leukemia With Low Leukemia Burden
This study is testing if a short-term treatment with blinatumomab can help people with low-burden B-cell leukemia get ready for a stem cell transplant.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 16 Years to 65 Years |
| Sex | All |
| Sponsor | Sichuan University Academic / other |
| Drugs / interventions | blinatumomab |
| Locations | 1 site (Chengdu, Sichuan) |
| Trial ID | NCT06111625 on ClinicalTrials.gov |
What this trial studies
This study evaluates the safety and efficacy of short-term blinatumomab as a bridging therapy for patients with low-burden B-cell lymphoblastic leukemia (B-ALL) who are undergoing allogeneic hemopoietic stem-cell transplantation (allo-HSCT). Participants aged 16 and older will receive intravenous blinatumomab, starting at a dose of 8 μg/day and escalating to 28 μg/day over 5 to 10 days. The study aims to determine how well this treatment can manage the disease before the transplant procedure.
Who should consider this trial
Good fit: Ideal candidates are patients aged 16 and older diagnosed with low-burden B-ALL who have complete disease status records.
Not a fit: Patients with a leukemia burden of 10% or more, severe organ dysfunctions, or central nervous system leukemia may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could improve outcomes for patients with low-burden B-ALL undergoing stem cell transplants.
How similar studies have performed: While there is limited data on this specific approach, similar therapies have shown promise in managing B-ALL in other contexts.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. patients diagnosed with B-ALL; 2. patients with age ≥ 16 years; 3. Availability of both pre- and post-transplantation disease status records. Exclusion Criteria: 1. administration of blinatumomab therapy for more than 14 days; 2. patients with leukemia burden ≥ 10% before initiation of treatment; 3. patients with severe organ dysfunctions before treatment, including myocardial infarction, chronic heart failure, decompensated liver dysfunction, renal dysfunction, or gastrointestinal dysfunction; 4. patients with central nervous system leukemia.
Where this trial is running
Chengdu, Sichuan
- West China Hospital of Sichuan University — Chengdu, Sichuan, China (Recruiting)
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.