Short-course blinatumomab for residual leukemia before stem cell transplant
Tests a short course of blinatumomab in adults with leukemia and detectable residual disease.
Plain-language title generated from the registry record
Registry title: Efficacy of Short-course Blinatumomab for MRD Erradication in B-ALL
Key facts
- Where
- Monterrey, MexicoSee the site
- Phase
- Phase 2
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 16 and 60 years old?
Source: NCT06886074, who can take part
Where in Mexico
- Hospital Universitario Dr. Jose E. GonzalezMonterrey, MexicoTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Hospital Universitario Dr. Jose E. Gonzalez
- Trial code
- NCT06886074
- Record updated
- 20 March 2025
- Original description
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 HSCTRead full original descriptionShow less
Efficacy of Short-course Blinatumomab in Patients With Detectable Measurable Residual Disease With Philadelphia Chromosome-negative B-cell Acute Lymphoblastyc Leukemia
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)
Inclusion: 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: Having previously received blinatumomab; Active extramedullary disease; 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.