Leukemia Clinical Trial
Official title:
A Randomized, Multi-Center, Double-Blind, Placebo-Controlled Trial Assessing The Safety And Efficacy Of Thalidomide (THALOMID) For The Treatment Of Anemia In Red Blood Cell Transfusion-Dependent Patients With Myelodysplastic Syndromes
RATIONALE: Thalidomide may be an effective treatment for anemia caused by myelodysplastic
syndrome.
PURPOSE: Randomized phase II trial to study the effectiveness of thalidomide in treating
anemia in patients who have myelodysplastic syndrome.
OBJECTIVES:
- Determine the efficacy of thalidomide for the treatment of anemia in patients with
myelodysplastic syndromes.
- Determine whether this drug reduces the frequency of leukemia transformation and
decreases bone marrow blast percentage in these patients.
- Determine the effect of this drug on neutrophil and platelet production and the number
of episodes of febrile neutropenia in these patients.
- Determine the safety of this drug in these patients.
OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients
are stratified according to International Prognostic Scoring System score (low and
intermediate-1 vs intermediate-2 and high) and transfusion dependence (yes vs no). Patients
are randomized to one of two treatment arms.
- Arm I: Patients receive oral thalidomide once daily on weeks 1-24.
- Arm II: Patients receive oral placebo once daily on weeks 1-24. In both arms, patients
who have not progressed to leukemia after 24 weeks of therapy may receive open-label
thalidomide for an additional 24 weeks in the absence of disease progression or
unacceptable toxicity.
Patients are followed at 4 weeks.
PROJECTED ACCRUAL: A total of 220 patients (110 per treatment arm) will be accrued for this
study.
;
Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Treatment
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