Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00030550
Status:
COMPLETED
Last Update Posted:
2013-01-31
First Post:
2002-02-14
Brief Title:
Thalidomide in Treating Anemia in Patients With Myelodysplastic Syndrome
Sponsor:
Roswell Park Cancer Institute
Organization:
Roswell Park Cancer Institute
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?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-G01-2044 | None | None | None |
| RPCI-DS-0116 | None | None | None |
| CELGENE-T-MDS-001 | None | None | None |