A Study of the Efficacy of ABT-199 in Subjects With Relapsed or Refractory Chronic Lymphocytic Leukemia With the 17p Deletion

Status: Recruiting
Diagnosis: Lymphoma
NCT ID: NCT01889186 (View complete trial on ClinicalTrials.gov)
DFCI Protocol ID: 13-463


This is a Phase 2, open label, multicenter, study evaluating the efficacy of ABT-199 in approximately 100 relapsed or refractory subjects with CLL harboring 17p13 (TP53 locus) deletion.


Conducting Institutions:
Brigham and Women's Hospital, Dana-Farber Cancer Institute

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

Site-responsible Investigators:

Dana-Farber Cancer Institute: Kathleen McDermott, kmcdermott@partners.org

Eligibility Criteria

Inclusion Criteria: - Subject must be greater than or equal to 18 years of age. - Subject must have diagnosis of CLL that meets published 2008 IWCLL NCI-WG (International Workshop for Chronic Lymphocytic Leukemia National Cancer Institute-Working Group) criteria. - Subject has an indication for treatment according to the 2008 IWCLL NCI WG criteria; - Subject has clinically measurable disease; - Subject must have relapsed or be refractory after receiving at least one prior line of therapy (a line of therapy is defined as completing at least 2 cycles of treatment for a given line of therapy); - Subjects must have 17p deletion, assessed by central laboratory, and determined by FISH using the Vysis CLL probe kit. - Subject has an Eastern Cooperative Oncology Group (ECOG) performance score of less than or equal to 2. - Subject must have adequate bone marrow function at Screening as follows: - Absolute Neutrophil Count (ANC) greater than or equal to 1000/μL, or - For subjects with an ANC less than 1000/μL at Screening and bone marrow heavily infiltrated with underlying disease (approximately 80% or more), granulocyte-colony stimulating factor (G-CSF) may be administered after Screening and prior to the first dose of ABT-199 to achieve the ANC eligibility criteria (greater than or equal to 1000/μL); - Platelets greater than 40,000/mm3 (entry platelet count must be independent of transfusion within 14 days of Screening); - Hemoglobin greater than or equal to 8.0 g/dL. - Subject must have adequate coagulation, renal, and hepatic function, per laboratory reference range at Screening as follows: - Activated partial thromboplastin time (aPTT) and prothrombin time (PT) not to exceed 1.5 × the upper limit of normal; - Calculated creatinine clearance greater than 50 mL/min using the Cockcroft-Gault equation or a 24-hour urine collection for Creatinine Clearance; - Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) less than or equal to 3.0 × the upper normal limit of institution's normal range; Bilirubin less than or equal to 1.5 × upper limit of normal. Subjects with Gilbert's Syndrome may have a bilirubin greater 1.5 × upper limit of normal, per discussion between the investigator and AbbVie medical monitor. - For subjects at high risk of tumor lysis syndrome a pre-approval by the AbbVie medical monitor is required prior to enrollment. Exclusion Criteria: - Subject has undergone an allogeneic stem cell transplant. - Subject has developed Richter's transformation. - Subject has active and uncontrolled autoimmune cytopenias (for 2 weeks), including autoimmune hemolytic anemia and idiopathic thrombocytopenic purpura. - Subject has previously received ABT-199. - Subject has received a biologic agent for anti-neoplastic intent within 8 weeks prior to the first dose of study drug. - Subject has received any of the following within 14 days prior to the first dose of study drug, or has not recovered to less than Common Toxicity Criteria (CTC) grade 2 clinically significant adverse effect(s)/toxicity(s) of the previous therapy: - Any anti-cancer therapy including chemotherapy, or radiotherapy; - Investigational therapy, including targeted small molecule agents. - Subject has known allergy to both xanthine oxidase inhibitors and rasburicase.
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