Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 4:46 PM
Ignite Modification Date:
2025-12-24 @ 4:46 PM
NCT ID:
NCT00030550
Brief Summary:
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.
Detailed Description:
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.
Study:
NCT00030550
Study Brief:
Protocol Section:
NCT00030550