Efficacy of Short-course Blinatumomab for MRD Erradication in B-ALL
About this study
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)
- Condition
- Acute Lymphoblastic Leukemia, Measurable Residual Disease (MRD)
- Tested
- Short course of blinatumomab
- Sponsor
- Hospital Universitario Dr. Jose E. Gonzalez
Who can join
- Age
- 16 to 60 years
- Sex
- All sexes
- Healthy volunteers
- Not accepted
Inclusion 8
- Minimum age: 16 years
- Maximum age: 60 years
- Study condition: Acute Lymphoblastic Leukemia, Measurable Residual Disease (MRD)
- 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 7
- 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
1 site, 1 recruiting
Hospital Universitario Dr. Jose E. Gonzalez
Monterrey, Nuevo León, Mexico
Contact
-
Andres Gomez-De Leon, Professor of Hematology
+528116089404 drgomezdeleon@gmail.com
Potential match only. Final eligibility is determined by the study team.