|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Sponsor: | Memorial Sloan-Kettering Cancer Center |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00077506 |
Purpose
RATIONALE: CC-5013 may stop the growth of myelodysplastic syndrome by stopping blood flow to the tumor.
PURPOSE: Phase II trial to study the effectiveness of CC-5013 in treating patients who have transfusion-dependent low-risk or intermediate-risk myelodysplastic syndrome.
| Condition | Intervention | Phase |
|---|---|---|
|
Leukemia Myelodysplastic Syndromes Myelodysplastic/Myeloproliferative Diseases |
Drug: lenalidomide |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Open Label |
| Official Title: | A Multicenter, Single-Arm, Open-Label Study Of The Efficacy And Safety Of CC-5013 Monotherapy In RBC Transfusion-Dependent Subjects With Myelodysplastic Syndromes |
| Study Start Date: | September 2003 |
| Primary Completion Date: | August 2005 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is an open-label, multicenter study.
Patients receive oral CC-5013 once daily on days 1-28. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.
PROJECTED ACCRUAL: A total of 136 patients 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 low- or intermediate-1-risk myelodysplastic syndromes (MDS)
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
Contacts and Locations| United States, New York | |
| Memorial Sloan-Kettering Cancer Center | |
| New York, New York, United States, 10021 | |
| Study Chair: | Virginia Klimek, MD | Memorial Sloan-Kettering Cancer Center |
More Information
| Study ID Numbers: | CDR0000352173, MSKCC-03109, CELGENE-CC-5013-MDS-002 |
| Study First Received: | February 10, 2004 |
| Last Updated: | August 6, 2009 |
| ClinicalTrials.gov Identifier: | NCT00077506 History of Changes |
| Health Authority: | United States: Federal Government |
|
chronic myelomonocytic leukemia previously treated myelodysplastic syndromes de novo myelodysplastic syndromes |
myelodysplastic/myeloproliferative disease, unclassifiable secondary myelodysplastic syndromes atypical chronic myeloid leukemia |
|
Neoplasms by Histologic Type Disease Precancerous Conditions Antineoplastic Agents Hematologic Diseases Myelodysplastic Syndromes Lenalidomide Myeloproliferative Disorders Pharmacologic Actions |
Leukemia Preleukemia Neoplasms Pathologic Processes Therapeutic Uses Syndrome Myelodysplastic-Myeloproliferative Diseases Bone Marrow Diseases |