A Phase 1 Study Evaluating the Safety and Pharmacokinetics of Venetoclax (ABT-199) in Subjects with Relapsed or Refractory Chronic Lymphocytic Leukemia and Non-Hodgkin Lymphoma
William G. Wierda
The goal of this clinical research study is to find the highest tolerable dose of ABT-199 that can be given patients with relapsed or refractory CLL, NHL, or SLL. The safety of this drug will also be studied. ABT-199 is designed to block a critical protein that the leukemia cells need to survive, which may kill cancer cells and shrink tumors. This is the first study using ABT-199 in humans.
Treatment Location: N/A
The primary objectives of this study are to assess the safety profile, characterize pharmacokinetics (PK), determine the maximum tolerated dose (MTD), determine the recommended phase 2 dose (RPTD), and determine the lead-in period regimen of ABT-199 in subjects with relapsed or refractory chronic lymphocytic leukemia (CLL) and non-Hodgkin lymphoma (NHL). Food effect will be studied in the NHL dose escalation portion of the study in Cohorts 1 - 6. The secondary objectives are to evaluatae preliminary efficacy data regarding the effect of ABT-199 on progression-free survival (PFS), objective response rate (ORR), time to tumor progression (TTP), overall survival (OS), and duration of response. Biomarkers and pharmacogenetics will also be evaluated as secondary objectives. Minimal residual disease (MRD), assessed in the peripheral blood and/or bone marrow (BM) either by flow cytometry or real-time PCR, will be measured in CLL subjects.
IRB Review and Approval Date: 04/05/2012
Recruitment Status: Closed
Projected Accrual: N/A
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William G. Wierda
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