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OpenTrials
Completed

NCT Number: NCT00044382

Study of the Safety and Efficacy of CC-5013 Treatment For Patients With Myelodysplastic Syndrome

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 .

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Key information

Conditions

Myelodysplastic Syndrome Bone Marrow Diseases Hematologic Diseases Hemic and Lymphatic Diseases Myelodysplastic Syndromes

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Arizona Cancer Center

Tucson, Arizona, 85724, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

  • 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.

Treatment and study plan

CC-5013

Drug

Sponsors and collaborators

Lead sponsor

Celgene

Industry

Registry information

Official study title

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

Important dates

Study start
2002
Primary completion
2007
Study completion
2007
First posted
Aug 29, 2002
Registry last updated
Nov 8, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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