Leukemia Clinical Trial
Official title:
A Phase I/II Study of Revlimid (Lenalidomide) in Combination With Vidaza (Azacitidine) in Patients With Advanced Myelodysplastic Syndrome (MDS)
RATIONALE: Lenalidomide may stop the growth of cancer cells by blocking blood flow to the
cancer. Lenalidomide may also stimulate the immune system in different ways and stop cancer
cells from growing. Drugs used in chemotherapy, such as azacitidine, work in different ways
to stop the growth of cancer cells, either by killing the cells or by stopping them from
dividing. Azacitidine may also cause cancer cells to look more like normal cells, and to grow
and spread more slowly. Giving lenalidomide together with azacitidine may kill more cancer
cells.
PURPOSE: This phase I trial is studying the side effects and best dose of lenalidomide and
azacitidine in treating patients with advanced myelodysplastic syndromes.
OBJECTIVES:
Primary
- Determine the maximum tolerated dose and dose-limiting toxicity of lenalidomide and
azacitidine in patients with advanced myelodysplastic syndromes (MDS).
Secondary
- Review clinical outcomes, as defined by the International Working Group criteria, in
patients treated with this regimen.
- Determine time to transformation to acute myeloid leukemia or death in patients treated
with this regimen.
- Determine time to relapse after achieving complete or partial remission in patients
treated with this regimen.
- Determine time to disease progression in patients treated with this regimen.
- Determine the effect of this regimen on hematologic status (including peripheral blood
counts and the need for platelet and/or red blood cell transfusions) in these patients.
OUTLINE: This is an open-label, multicenter, dose-escalation study.
Patients receive oral lenalidomide once daily on days 1-14 or days 1-21 and azacitidine
subcutaneously once daily on days 1-5 or days 1-5 and 8-12. Treatment repeats every 28 days
for up to 7 courses in the absence of relapse (after achieving complete or partial
remission), disease progression, or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses and/or increasing dosing frequencies of
lenalidomide and azacitidine until the maximum tolerated dose (MTD) is determined or the
sixth dose level is reached, whichever occurs first. The MTD is defined as the dose preceding
that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity during the first
course of therapy.
After completion of study treatment, patients are followed annually.
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