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| Sponsor: | Roswell Park Cancer Institute |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00030550 |
Purpose
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 | Intervention | Phase |
|---|---|---|
|
Leukemia Myelodysplastic Syndromes Myelodysplastic/Myeloproliferative Diseases |
Drug: thalidomide |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double-Blind, Placebo Control |
| 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 |
OBJECTIVES:
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.
Patients are followed at 4 weeks.
PROJECTED ACCRUAL: A total of 220 patients (110 per treatment arm) will be accrued for this study.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of myelodysplastic syndromes (MDS) of at least 12 weeks duration
No iron deficiency (e.g., absent bone marrow iron store)
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Pulmonary:
Neurologic:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Contacts and Locations| United States, New York | |
| Roswell Park Cancer Institute | |
| Buffalo, New York, United States, 14263-0001 | |
| United States, North Carolina | |
| PPD Development | |
| Wilmington, North Carolina, United States, 28412 | |
| Study Chair: | James L. Slack, MD | Roswell Park Cancer Institute |
More Information
| Study ID Numbers: | CDR0000069176, RPCI-DS-0116, CELGENE-T-MDS-001, NCI-G01-2044 |
| Study First Received: | February 14, 2002 |
| Last Updated: | July 23, 2008 |
| ClinicalTrials.gov Identifier: | NCT00030550 History of Changes |
| Health Authority: | United States: Federal Government |
|
refractory anemia refractory anemia with ringed sideroblasts refractory anemia with excess blasts de novo myelodysplastic syndromes |
chronic myelomonocytic leukemia previously treated myelodysplastic syndromes myelodysplastic/myeloproliferative disease, unclassifiable atypical chronic myeloid leukemia |
|
Anti-Infective Agents Precancerous Conditions Thalidomide Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs Leukemia Anti-Bacterial Agents Preleukemia Pathologic Processes Syndrome Therapeutic Uses Growth Inhibitors Angiogenesis Modulating Agents |
Disease Neoplasms by Histologic Type Hematologic Diseases Growth Substances Myelodysplastic Syndromes Myeloproliferative Disorders Anemia Immunosuppressive Agents Angiogenesis Inhibitors Pharmacologic Actions Neoplasms Bone Marrow Diseases Myelodysplastic-Myeloproliferative Diseases Leprostatic Agents |