Efficacy of Short-course Blinatumomab for MRD Erradication in B-ALL

Sponsor
Hospital Universitario Dr. Jose E. Gonzalez
Study ID
NCT06886074
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
16 Years - 60 Years
Healthy Volunteers
Not accepted

Interventions

  • Short course of blinatumomab — DRUG
    Patients will receive 175 mcg of blinatumomab trough out seven days in a 24-hours infusion. Blinatumomab therapy will be assigned 17.5 mcg per day for the first 2 days. Then blinatumomab 28 mcg per day for 5 days (completing 7 days). A single intravenous 20 mg dose of dexamethasone will be applied one hour before starting dose.

Study Details

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)

Key Dates

First listed
Mar 20, 2025
Start date
Jan 2, 2025
Status verified
Mar 2025
Primary completion
Jan 31, 2027
Completion
Jun 30, 2027

Study Design

Enrollment
30 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Blinatumomab arm
    Patients will receive 7 days of blinatumomab with a fixed dose of 175 mcg through out 7 days

Primary Outcome Measure

Efficacy to eradicate MRD in negative Philadelphia-chromosome B-cell acute lymphoblastic leukemia [ Time Frame: 24 months ]

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