Efficacy of Short-course Blinatumomab in Patients With Detectable Measurable Residual Disease With Philadelphia Chromosome-negative B-cell Acute Lymphoblastyc Leukemia

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

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)

Eligibility
Participation Requirements
Sex: All
Minimum Age: 16
Maximum Age: 60
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Mexico
Hospital Universitario Dr. Jose E. Gonzalez
RECRUITING
Monterrey
Contact Information
Primary
Andres Gomez-De Leon, Professor of Hematology
drgomezdeleon@gmail.com
+528116089404
Time Frame
Start Date: 2025-01-02
Estimated Completion Date: 2027-06
Participants
Target number of participants: 30
Treatments
Experimental: Blinatumomab arm
Patients will receive 7 days of blinatumomab with a fixed dose of 175 mcg through out 7 days
Sponsors
Leads: Hospital Universitario Dr. Jose E. Gonzalez

This content was sourced from clinicaltrials.gov

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