Ibrutinib and Blinatumomab in Treating Patients With Relapsed or Refractory B Acute Lymphoblastic Leukemia

Part of paid clinical trials in Los Angeles, California.

Sponsor
University of California, Davis
Study ID
NCT02997761
Phase
PHASE2
Status
Completed

Conditions

  • Adult B Acute Lymphoblastic Leukemia
  • Philadelphia Chromosome Positive

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Blinatumomab — BIOLOGICAL
    Given IV
  • Ibrutinib — DRUG
    Given PO

Study Details

This phase II trial studies how well ibrutinib and blinatumomab work in treating patients with B acute lymphoblastic leukemia that has come back or is not responding to treatment. Ibrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as blinatumomab, may interfere with the ability of cancer cells to grow and spread. Giving ibrutinib and blinatumomab may work better in treating patients with relapsed or refractory B acute lymphoblastic leukemia.

Key Dates

Start date
Jun 27, 2017
Status verified
Jun 2026
Primary completion
Jul 17, 2025
Completion
Jul 17, 2025

Study Design

Enrollment
19 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (ibrutinib, blinatumomab)
    INDUCTION THERAPY: Patients receive ibrutinib PO QD on days 1-49 of course 1 and days 1-42 of course 2, and blinatumomab IV on days 8-35 of course 1 and days 1-28 of course 2 in the absence of disease progression or unacceptable toxicity. CONSOLIDATION THERAPY: Patients with CR/CRi after Induction Therapy receive ibrutinib PO QD on days 1-42 and blinatumomab IV on days 1-28. Treatment repeats every 42 days for up to 3 courses in the absence of disease progression or unacceptable toxicity. MAINTENANCE THERAPY: Patients receive ibrutinib PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Rate of Complete Remission (CR). [ Time Frame: Up to about 3 months from start of study treatment. ]

Locations (2)

FacilityCityStateZIPSite coordinators
USC/Norris Comprehensive Cancer CenterLos AngelesCalifornia90033-
University of California Davis Comprehensive Cancer CenterSacramentoCalifornia95817-

Find similar trials in Los Angeles, CA

By research site
USC/Norris Comprehensive Cancer Center· Los Angeles, CAUniversity of California Davis Comprehensive Cancer Center· Sacramento, CA

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