Leukemia, Myeloid, Chronic Clinical Trial
Official title:
Phase II Exploratory Study Of AG-858 Plus Gleevec™ In Patients With Chronic Myelogenous Leukemia (CML) In Chronic Phase Who Are Cytogenetically Positive After Treatment With Gleevec™
This is a Phase II, exploratory, open-label study of the investigational product AG-858, in
patients who are cytogenetically positive after treatment with Gleevec.
The trial will consist of three independent Phase II evaluations of patient groups according
to their cytogenetic status as defined in the eligibility criteria (Eligibility Criteria 4a,
4b, and 4c).
The goals of this study are to determine the following:
- To estimate the proportion of patients with a complete cytogenetic response (CCR)
within each patient group
- To estimate the proportion of patients with a substantial molecular response (SMR)
within each patient group
- To evaluate the frequency and severity of adverse events.
- To assess the feasibility of AG-858 production.
;
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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