Trials / Terminated
TerminatedNCT02129062
Ibrutinib in Treating Patients With Relapsed or Refractory B-cell Acute Lymphoblastic Leukemia
A Phase 2 Study to Determine the Efficacy of the BTK Inhibitor Ibrutinib (PCI-32765) in Patients With Relapsed or Refractory Precursor-B Lymphoblastic Leukemia (B-ALL)
- Status
- Terminated
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 3 (actual)
- Sponsor
- National Cancer Institute (NCI) · NIH
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This phase II trial studies how well ibrutinib works in treating patients with B-cell acute lymphoblastic leukemia that has come back after treatment or has not responded to other treatment. Ibrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.
Detailed description
PRIMARY OBJECTIVES: I. To evaluate the efficacy of ibrutinib in patients with relapsed or refractory B-cell acute lymphoblastic leukemia (B-ALL) as measured by objective response rate (ORR). SECONDARY OBJECTIVES: I. To evaluate the global safety profile of ibrutinib in patients with relapsed or refractory B-ALL. II. To assess response duration. III. To assess Bruton's tyrosine kinase (BTK) target inhibition, biomarkers, and gene expression profiles in B-ALL patient samples before and during treatment with ibrutinib. OUTLINE: Patients receive ibrutinib orally (PO) once daily (QD) on days 1-28. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up at 30 days.
Conditions
- Adult B Acute Lymphoblastic Leukemia
- Adult B Acute Lymphoblastic Leukemia With t(9;22)(q34;q11.2); BCR-ABL1
- Recurrent Adult Acute Lymphoblastic Leukemia
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Ibrutinib | Given orally 560 mg daily (dispensed as 4 x 140-mg capsules) |
| OTHER | Laboratory Biomarker Analysis | Correlative studies |
Timeline
- Start date
- 2014-04-01
- Primary completion
- 2015-11-01
- Completion
- 2015-11-01
- First posted
- 2014-05-02
- Last updated
- 2017-01-16
- Results posted
- 2017-01-16
Locations
8 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT02129062. Inclusion in this directory is not an endorsement.