Ignite Creation Date:
2025-12-24 @ 4:46 PM
Ignite Modification Date:
2025-12-29 @ 9:47 AM
Study NCT ID:
NCT00030550
Status:
COMPLETED
Last Update Posted:
2013-01-31
First Post:
2002-02-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Thalidomide in Treating Anemia in Patients With Myelodysplastic Syndrome
Sponsor:
Roswell Park Cancer Institute
Organization:
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2013-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
* 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 Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: