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A Phase II Open Label Study of the Safety and Efficacy of CC-5013 Treatment For Patients With Myelodysplastic Syndrome


Phase 2
18 Years
N/A
Not Enrolling
Both
Myelodysplastic Syndrome

Thank you

Trial Information

A Phase II Open Label Study of the Safety and Efficacy of CC-5013 Treatment For Patients With Myelodysplastic Syndrome

Inclusion 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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Authority:

United States: Food and Drug Administration

Study ID:

CC-5013-MDS-501-001

NCT ID:

NCT00044382

Start Date:

February 2002

Completion Date:

Related Keywords:

  • Myelodysplastic Syndrome
  • Revimid
  • CC5013
  • CC-5013
  • Myelodysplastic Syndromes
  • Preleukemia

Name

Location

Arizona Cancer CenterTucson, Arizona  85724