Marfan Syndrome |
Arachnodactyly; MFS |
Clinical Trial: Study of the Safety and Efficacy of CC-5013 Treatment For Patients with Myelodysplastic Syndrome
This study is no longer recruiting patients.
|
Purpose
To estimate the percent of patients with myelodysplastic syndromes (MDS) who experience erythroid response and the interval to response with daily treatment of 25 mg of CC-5013 .
| Condition | Treatment or Intervention | Phase |
|---|---|---|
| Myelodysplastic Syndrome | Drug: CC-5013 | Phase II |
MedlinePlus related topics: Blood and Blood Disorders; Bone Marrow Diseases; Cancer; Cancer Alternative Therapy
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study
Official Title: A Phase II Open Label Study of the Safety and Efficacy of CC-5013 Treatment For Patients with Myelodysplastic Syndrome
Expected Total Enrollment: 25
Study start: February 2002; Study completion: August 2005
Eligibility
Ages Eligible for Study: 18 Years and above, Genders Eligible for Study: Both
Criteria
- Diagnosis of de novo myelodysplastic syndrome of at least 12 weeks duration.
- Baseline mean hemoglobin < 10.0 g/dL (untransfused) and/or be transfusion dependent defined by requiring at least 4 units of RBC in the 8 weeks prior to baseline.
- More than 30 days must have elapsed since any previous treatment for MDS, other than transfusion.
- Women must not be pregnant or lactating
- No use of another experimental study drug within 30 dy\ays of baseline
- Understand and sign written informed consent
- Able to adhere to study visit schedule, understand and comply with other protocol requirements.
Location Information
More Information
Record last reviewed: May 2004
Last Updated: October 13, 2004
Record first received: August 27, 2002
ClinicalTrials.gov Identifier: NCT00044382
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08
Source: ClinicalTrials.gov
Cache Date: April 9, 2005
Resources
- About Marfan Syndrome: Diagnosis (National Marfan Foundation)
- Cardiac Concerns (National Marfan Foundation)

Not Signed In -

