Thalidomide in Treating Anemia in Patients With Myelodysplastic Syndrome
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|ClinicalTrials.gov Identifier: NCT00030550|
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : January 31, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Leukemia Myelodysplastic Syndromes Myelodysplastic/Myeloproliferative Neoplasms||Drug: thalidomide||Phase 2|
- 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 Type :||Interventional (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|
|Study Start Date :||September 2001|
|Actual Primary Completion Date :||June 2003|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00030550
|United States, North Carolina|
|Wilmington, North Carolina, United States, 28412|
|Study Chair:||James L. Slack, MD||Roswell Park Cancer Institute|