NCT06886074RecruitingPhase 2
Efficacy of Short-course Blinatumomab for MRD Erradication in B-ALL
Efficacy of Short-course Blinatumomab in Patients With Detectable Measurable Residual Disease With Philadelphia Chromosome-negative B-cell Acute Lymphoblastyc Leukemia
Source: ClinicalTrials.gov · Last updated 20 Mar 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
Detectable measurable residual disease (MRD) is the most important prognostic factor for B-cell acute lymphoblastic leukemia (B-ALL) for overall survival (OS) and disease-free survival (DFS). Patients who are MRD positive and have no access to novel immunotherapies should receive an allogeneic hematopoietic stem cell transplantation (HSCT). Blinatumomab is considered a standard of care (SOC) for this group of patients, however, the ideal treatment dose for MRD is unknown as doses were adjusted from the relapsed/refractory setting. Preliminary data suggest short cycles of blinatumomab can also be effective in states of lower disease burden prior to transplant. Thus, the investigators are performing a phase 2 trial assessing 7 days of blinatumomab as a bridge to HSCT Primary endpoint is assessing the MRD response following a short-course blinatumomab infusion in patients with B-ALL with complete response (CR) and have detectable MRD disease who are candidates for HSCT. Secondary endpoints include incidence of adverse events, OS, DFS, percentage of patients who receive HSCT, incidence of cytokine release syndrome (CRS) and immune effector cell associated neurotoxicity syndrome (ICANS)
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- First submitted
- 3 Mar 2025
- Start date
- 2 Jan 2025
- Primary completion date
- Jan 2027
- Lead sponsor
- Hospital Universitario Dr. Jose E. Gonzalez
- NCT number
- NCT06886074
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 30
- From 2 Jan 2025 to the primary completion date, Jan 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Having previously received blinatumomab
Other illness
- Active extramedullary disease
Other
- 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)
- Absence of related or unrelated donors
Who the study is looking for
- 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
Age in the registry: 16 years to 60 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hospital Universitario Dr. Jose E. Gonzalez Coordinator of this site? Confirm its status | Monterrey | Mexico | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.