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

Status: Recruiting
Phase:
Diagnosis: Leukemia/MDS, Non-Hodgkin's Lymphoma
NCT ID: NCT01328626 (View complete trial on ClinicalTrials.gov)
DFCI Protocol ID: 11-169

 

This is a Phase 1, open-label, multicenter study evaluating the safety and pharmacokinetics profile of ABT-199 under a once daily dosing schedule in approximately 72 subjects with relapsed or refractory chronic lymphocytic leukemia (CLL) and non-Hodgkin's Lymphoma (NHL). Two arms will be implemented for dose escalation: Arm A, CLL/small lymphocytic lymphoma (SLL) subjects, and Arm B, NHL subjects. The dose escalation phase for each arm will include approximately 24 subjects, with the objective of defining dose limiting toxicities (DLTs) and the maximum tolerated dose (MTD). Once the MTD is declared for an arm, approximately 12 additional subjects will be enrolled into the arm in an expanded safety cohort. In addition, subjects in the Arm B (NHL) dose escalation of the study will be evaluated for the food effect of ABT-199.

 

Conducting Institutions:
Dana-Farber Cancer Institute

Overall PI:
Matthew Davids, MD, Dana Farber Cancer Institute

Site-responsible Investigators:

Contacts:
Dana-Farber Cancer Institute: Ilene Galinsky, 617-632-3902, igalinsky@partners.org

Eligibility Criteria

Inclusion Criteria - Subject must be at least 18 years of age. - Subject must have either: - (Arm A) relapsed or refractory CLL/SLL and require treatment in the opinion of the Investigator. Subject must have relapsed following or be refractory to standard treatments such as fludarabine based regimens (F, FC, FR, FCR) or alkylator (chlorambucil, bendamustine) based regimens. In addition, the subject is unable to tolerate other available therapies or no other therapies are available. or - (Arm B) relapsed or refractory NHL and require treatment in the opinion of the Investigator. Subject must have histologically documented diagnosis of NHL as defined in the World Health Organization classification scheme, except as noted in the exclusion criteria. Subject must have relapsed following or be refractory to standard treatments such as R-CHOP, R-CVP, or fludarabine based regimens. In addition, the subject is unable to tolerate other available therapies or no other therapies are available. Subjects with other lymphoproliferative diseases can be considered in consultation with the Abbott medical monitor. - Subject has an Eastern Cooperative Oncology Group (ECOG) performance score less than or equal to 1. - Subject must have adequate bone marrow independent of growth factor support per local laboratory reference range at Screening. - Subject must have adequate coagulation, renal, and hepatic function, per laboratory reference range at Screening. Exclusion Criteria - CLL subject has undergone an allogeneic or autologous stem cell transplant or NHL subject has undergone an allogeneic stem cell transplant or has been diagnosed with Post-Transplant Lymphoproliferative Disease, Burkitt's lymphoma, Burkitt-like lymphoma, or lymphoblastic lymphoma/leukemia. - Subject has tested positive for HIV (due to potential drug-drug interactions between anti-retroviral medications and ABT-199, as well as anticipated ABT-199 mechanism based lymphopenia that may potentially increase the risk of opportunistic infections and potential drug-drug interactions with certain anti infective agents). - Subject has a cardiovascular disability status of New York Heart Association Class greater or equal to 2. Class 2 is defined as cardiac disease in which patients are comfortable at rest but ordinary physical activity, results in fatigue, palpitations, dyspnea or anginal pain. - Subject has a significant history of renal, neurologic, psychiatric, endocrinologic, metabolic, immunologic, or hepatic disease that in the opinion of the Investigator would adversely affect his/her participating in this study.
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