A Phase II Study Of CCI-779 In Patients With Relapsed Or Refractory Acute Myeloid Leukemia, Acute Lymphocytic Leukemia, Or Chronic Myeloid Leukemia In Blastic-Phase
I. Determine the activity of CCI-779 in patients with relapsed or refractory acute myeloid
leukemia, acute lymphoblastic leukemia, myelodysplastic syndromes, or chronic myelogenous
leukemia in blastic phase.
II. Correlate the effect of this drug with altered mitochondrial respiration in the leukemia
cells of these patients.
OUTLINE: Patients are stratified according to disease (acute myeloid leukemia,
myelodysplastic syndromes, chronic myelogenous leukemia in blastic phase [CML-BP]
non-lymphoid vs acute lymphoblastic leukemia, CML-BP lymphoid).
Patients receive CCI-779 IV over 30 minutes on days 1, 8, 15, and 22. Courses repeat every
28 days in the absence of disease progression or unacceptable toxicity.
Patients are followed every 2 months.
PROJECTED ACCRUAL: A total of 24-74 patients (12-37 per stratum) will be accrued for this
study within 8-46 months.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Response rate of 20%
The 95% confidence intervals should be provided.
Up to 3 years
M.D. Anderson Cancer Center
United States: Food and Drug Administration
|M D Anderson Cancer Center||Houston, Texas 77030|