A Phase II Study of CCI-779 in Patients With Relapsed, Refractory or Transformed Chronic Lymphocytic Leukemia
I. Determine the activity of CCI-779 in patients with relapsed, refractory, or transformed
chronic lymphocytic leukemia.
OUTLINE: Patients are stratified according to disease (relapsed or refractory chronic
lymphocytic leukemia [CLL] vs transformed CLL).
Patients receive CCI-779 IV over 30 minutes on days 1, 8, 15, and 22. Treatment repeats
every 28 days for up to 6 courses in the absence of disease progression or unacceptable
toxicity. Patients achieving an objective response may receive 3 consolidation courses of
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Response (CR or PR)
Defined as the complete disappearance of all known disease, or a 50% decrease in tumor size using the sum of the product (bi-perpendicular dimensions when available).
M.D. Anderson Cancer Center
United States: Food and Drug Administration
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