Spots Global Cancer Trial Database for Ibrutinib and Azacitidine for Treatment of Higher Risk Myelodysplastic Syndrome
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Trial Identification
Brief Title: Ibrutinib and Azacitidine for Treatment of Higher Risk Myelodysplastic Syndrome
Official Title: Phase 1b Trial of the Combination of Ibrutinib and Azacitidine for the Treatment of Higher Risk Myelodysplastic Syndromes in Previously Treated Patients or in Untreated Patients Unfit for or Who Refuse Intense Therapy
Study ID: NCT02553941
Study Description
Brief Summary: This phase Ib trial studies the side effects and best dose of ibrutinib when given together with azacitidine in treating patients with myelodysplastic syndrome that is likely to occur or spread (higher risk) and who were previously treated or untreated and unfit for or refused intense therapy. Ibrutinib and azacitidine 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 safety and tolerability of ibrutinib in combination with azacitidine in patients with higher risk myelodysplastic syndrome (MDS) and to determine the maximum tolerated dose (MTD) or recommended Phase 2 dose of ibrutinib combined with azacitidine. SECONDARY OBJECTIVES: I. To do an early assessment of the efficacy of the combination of ibrutinib and azacitidine in higher risk MDS. Specific secondary endpoints include: disease response per modified International Working Group (IWG) 2006 response criteria for MDS, hematologic normalization rate (HNR = complete remission \[CR\] + partial remission \[PR\] + hematologic improvement \[HI\]), overall survival (OS), progression free survival (PFS), disease free survival (DFS), and time to response (TTR). TERTIARY OBJECTIVES: I. To evaluate the pharmacodynamic and biological effects and impact of quality of life (QoL) of the combination of ibrutinib and azacitidine in patients with higher risk MDS is the exploratory objective of this study. Exploratory endpoints include: laboratory biomarker analysis and effect on QoL assessments. OUTLINE: This is a dose-escalation study of ibrutinib. Patients receive azacitidine intravenously (IV) over 10-40 minutes or subcutaneously (SC) once daily (QD) on days 1-7 or 1-5 and 8-9, and ibrutinib orally (PO) QD on days 1-28. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 3 months for 6 months.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
UCLA / Jonsson Comprehensive Cancer Center, Los Angeles, California, United States
UC Irvine Health/Chao Family Comprehensive Cancer Center, Orange, California, United States
University of California Davis Comprehensive Cancer Center, Sacramento, California, United States
University of California San Diego, San Diego, California, United States
University of California, San Francisco, San Francisco, California, United States
Contact Details
Name: Brian Jonas
Affiliation: University of California, Davis
Role: PRINCIPAL_INVESTIGATOR
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