Trials / Completed
CompletedNCT02997761
Ibrutinib and Blinatumomab in Treating Patients With Relapsed or Refractory B Acute Lymphoblastic Leukemia
A Phase 2 Study of Ibrutinib and Blinatumomab in Relapsed and Refractory B-Cell Acute Lymphoblastic Leukemia
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 19 (actual)
- Sponsor
- University of California, Davis · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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.
Detailed description
PRIMARY OBJECTIVES: I. To evaluate the efficacy of ibrutinib and blinatumomab in patients with relapsed or refractory B acute lymphoblastic leukemia (B-ALL) as measured by complete response (CR) rate. SECONDARY OBJECTIVES: I. To further examine the efficacy and safety of ibrutinib and blinatumomab in patients with relapsed or refractory B-ALL as measured by overall response rate (ORR, defined as CR plus CR with incomplete count recovery \[CRi\]), relapse free survival (RFS), overall survival (OS), minimal residual disease (MRD) response, proportion of patients bridged to allogeneic hematopoietic cell transplant (allo-HCT), and toxicity.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Blinatumomab | Given IV |
| DRUG | Ibrutinib | Given PO |
Timeline
- Start date
- 2017-06-27
- Primary completion
- 2025-07-17
- Completion
- 2025-07-17
- First posted
- 2016-12-20
- Last updated
- 2026-04-07
Locations
2 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT02997761. Inclusion in this directory is not an endorsement.