Chronic Myelomonocytic Leukemia Clinical Trial
Official title:
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
Drugs used in chemotherapy such as CCI-779 work in different ways to stop cancer cells from dividing so they stop growing or die. This phase II trial is studying how well CCI-779 works in treating patients with relapsed or refractory acute myeloid leukemia, acute lymphoblastic leukemia, myelodysplastic syndrome, or chronic myelogenous leukemia in blastic phase
PRIMARY OBJECTIVES:
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
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