Spots Global Cancer Trial Database for Ibrutinib in Treating Patients With Relapsed or Refractory B-cell Acute Lymphoblastic Leukemia
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Trial Identification
Brief Title: Ibrutinib in Treating Patients With Relapsed or Refractory B-cell Acute Lymphoblastic Leukemia
Official Title: 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)
Study ID: NCT02129062
Study Description
Brief 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.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
City of Hope Comprehensive Cancer Center, Duarte, California, United States
USC / Norris Comprehensive Cancer Center, Los Angeles, California, United States
UC Davis Comprehensive Cancer Center LAPS, Sacramento, California, United States
Moffitt Cancer Center, Tampa, Florida, United States
University of Chicago Comprehensive Cancer Center, Chicago, Illinois, United States
Rutgers Cancer Institute of New Jersey, New Brunswick, New Jersey, United States
Penn State Milton S Hershey Medical Center, Hershey, Pennsylvania, United States
M D Anderson Cancer Center, Houston, Texas, United States
Contact Details
Name: Jan Burger
Affiliation: M.D. Anderson Cancer Center
Role: PRINCIPAL_INVESTIGATOR
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