ASH News Daily 2013 - Day 3 - (Page B-17)
Now enrolling
Investigating ABT-199 (GDC-0199)
in Chronic Lymphocytic Leukemia
Phase II Open-Label Study of the Efficacy and Safety of
ABT-199 in Patients With Relapsed or Refractory Chronic
Lymphocytic Leukemia Harboring the 17p Deletion
N=100
ABT-199 is an investigational agent that has not been approved by regulatory agencies for the use
under investigation in this trial.
Primary Endpoint
Secondary Endpoints
* Overall response rate
*
*
*
*
*
*
*
*
Complete remission rate
Partial remission rate
Duration of response
Progression-free survival
Time to progression
Overall survival
Percentage of patients who move on to stem-cell transplant
Safety and tolerability of ABT-199
Key Inclusion Criteria
* Adult patients ≥18 years of age
* Diagnosis of CLL that meets 2008 IWCLL NCI-WG criteria
(relapsed/refractory after receiving ≥1 prior line of therapy
and 17p deletion)
* ECOG performance score of ≤2
* Adequate bone marrow function
* Adequate coagulation, renal, and hepatic function, per laboratory
reference range
To learn more about this study,
please visit www.ClinicalTrials.gov.
NCT#01889186
Reference: ClinicalTrials.gov.
@ 2013 Genentech USA, Inc. All rights reserved. BIO0001961500 Printed in USA.
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ASH News Daily 2013 - Day 3
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