Short-course blinatumomab treatment for B-ALL patients with measurable residual disease
Efficacy of Short-course Blinatumomab in Patients With Detectable Measurable Residual Disease With Philadelphia Chromosome-negative B-cell Acute Lymphoblastyc Leukemia
This study tests whether a short treatment with blinatumomab can help people with B-cell acute lymphoblastic leukemia who still have some cancer cells left after their initial treatment, before they get a stem cell transplant.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 16 Years to 60 Years |
| Sex | All |
| Sponsor | Hospital Universitario Dr. Jose E. Gonzalez Academic / other |
| Drugs / interventions | blinatumomab, immunotherapy |
| Locations | 1 site (Monterrey, Nuevo León) |
| Trial ID | NCT06886074 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the efficacy of a short course of blinatumomab in patients with B-cell acute lymphoblastic leukemia (B-ALL) who have detectable measurable residual disease (MRD) after achieving a complete response. The treatment involves administering blinatumomab over a 7-day period as a bridge to allogeneic hematopoietic stem cell transplantation (HSCT). The primary goal is to assess the MRD response following this short-course therapy, with evaluations conducted through bone marrow aspiration and next-generation flow cytometry. The study aims to determine the optimal dosing regimen for blinatumomab in this specific patient population.
Who should consider this trial
Good fit: Ideal candidates for this study are patients with Philadelphia chromosome-negative B-ALL who have detectable MRD after achieving a complete response and are candidates for HSCT.
Not a fit: Patients with performance status greater than 2, active central nervous system infiltration, or those who have previously received blinatumomab may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could improve MRD eradication rates in B-ALL patients, potentially leading to better overall survival and disease-free survival outcomes.
How similar studies have performed: While blinatumomab has been established as a standard of care in relapsed/refractory settings, this specific short-course approach is novel and has not been extensively tested in this context.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Philadelphia chromosome-negative B-cell acute lymphoblastic leukemia * MRD detectable in complete response (above the limit of quantification according to FCM) * Performance status 0-2 on the ECOG scale * No prior organ damage * Having a potential related or unrelated donor Exclusion Criteria: * Performance status on the ECOG scale \>2 * HCT-CI \>3 points * Patients who do not wish to participate in clinical study. * Active central nervous system infiltration (CNS3) * Active extramedullary disease * Having previously received blinatumomab * Absence of related or unrelated donors
Where this trial is running
Monterrey, Nuevo León
- Hospital Universitario Dr. Jose E. Gonzalez — Monterrey, Nuevo León, Mexico (Recruiting)
Study contacts
- Study coordinator: Andres Gomez-De Leon, Professor of Hematology
- Email: drgomezdeleon@gmail.com
- Phone: +528116089404
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.