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A Phase 1 Study Evaluating the Safety and Pharmacokinetics of ABT-199 in Subjects With Relapsed or Refractory Chronic Lymphocytic Leukemia and Non-Hodgkin's Lymphoma

Complete title: A Phase 1 Study Evaluating the Safety, Pharmacokinetics of ABT-199 in Subjects with Relapsed or Refractory Chronic Lymphocytic Leukemia and Non-Hodgkin's Lymphoma

Research Study Number       2515.00
    
Principal Investigator       John Pagel, MD, PhD
    
Phase       I

Look up trial at NIH

Research Study Description

This is a Phase 1, open-label, multicenter study evaluating the safety and PK profile of ABT-199 under a once daily dosing schedule. Two arms will be implemented for dose escalation: Arm A, CLL/SLL subjects and Arm B, NHL subjects. Arm A is designed to enroll approximately 78 subjects with relapsed or refractory CLL or SLL and Arm B is designed to enroll approximately 52 subjects with relapsed or refractory NHL. Approximately 42 subjects will be enrolled in Arm A and approximately 28 subjects will be enrolled in Arm B during the dose escalation portion of the study, with the objective of defining dose limiting toxicities (DLTs) and the MTD. Once the MTD is declared for the arm, approximately 36 additional CLL/SLL subjects and approximately 24 additional NHL subjects (with a potential to enroll a sub-set of 12 subjects with mantle cell lymphoma) will be enrolled in an expanded safety portion of the study at the recommended phase 2 dose (RPTD) and schedule.

Eligibility Criteria (must meet the following to participate in this study)

** For Eligibility information, please click on the "Look up trial at NIH" link above. **

Other eligibility criteria may apply.



Research Study Number       2515.00
    
Contact       Seattle Cancer Care Alliance Intake Office
    
Telephone       800-804-8824 / 206-288-1024
    
   

Keywords
Chronic Lymphoid Leukemia (CLL); Hematologic Malignancies; Leukemia; Lymphoma; Non-Hodgkin's Lymphoma (NHL)

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