M13-982: A Phase 2 Open-Label Study of the Efficacy of ABT-199 (GDC-0199) in Subjects with Relapsed or Refractory Chronic Lymphocytic Leukemia Harboring the 17p Deletion

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M13-982: A Phase 2 Open-Label Study of the Efficacy of ABT-199 (GDC-0199) in Subjects with Relapsed or Refractory Chronic Lymphocytic Leukemia Harboring the 17p Deletion

Primary objective: The primary objective of this study is to evaluate the efficacy of ABT-199
monotherapy in subjects with relapsed or refractory chronic lymphocytic leukemia (CLL) harboring the
17p deletion. Efficacy will be measured by overall response rate (ORR).
Secondary objectives: The secondary objectives are to evaluate the duration of response,
progression-free survival (PFS), time to progression (TTP), overall survival (OS) and percent of subjects
who move on to stem cell transplant. The safety and tolerability of ABT-199 in subjects with relapsed
or refractory CLL harboring 17p deletion will also be evaluated.
Exploratory objectives: Time to next anti-CLL treatment (TTNT) will be evaluated. Minimal residual
disease (MRD) will be assessed in the peripheral blood and bone marrow (BM) either by flow cytometry
or real-time PCR. Pharmacokinetics, pharmacogenetics and biomarkers may also be evaluated as
exploratory objectives. Health Economic and Patient-Reported Outcome Measures will include the
MDASI (measure of patient reported symptoms), the EORTC QLQ-C30 and EORTC QLQ CLL16 (a
measure of health related quality of life specific to CLL) and the EQ-5D-5L (measure of general health
status) and EQ-5D-VAS.

Protocol Number021301
Principal InvestigatorRajat Bannerji
PhasePhase II
ScopeNational
Applicable Disease SitesMyeloid and Monocytic Leukemia
Leukemia, other
Therapies InvolvedChemotherapy single agent systemic
Drugs InvolvedABT-199
Participating InstitutionsRutgers Cancer Institute of New Jersey

For further information on this clinical trial, please contact us at 732-235-8675 or cinjclinicaltrials@umdnj.edu.