Skip to main content
OpenTrials
Completed

NCT Number: NCT01099267

Multi-center, Survival Data Collection in Subjects Previously Enrolled in Celgene Protocol CC-5013-MDS-003

Multi-center, survival data collection in subjects previously enrolled in study NCT00065156 (Celgene Protocol CC-5013-MDS-003).

Completed

Looking for future studies?

Notify Me

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

Observational

Primary location

St. Johannes Hospital, Duisburg, Germany

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Must have been enrolled in the Celgene protocol CC-5013-MDS-003 study.
  • Must understand and be able to give informed consent (if a subject is deceased, proper legal consent (i.e. next of kin, legal representative) will be obtained prior to collection of data).

Exclusion criteria

  • Consent refused for any reason at current or long-term follow up completed in 2007 (long-term follow up: survival data collection completed to obtain further safety information on CC-5013-MDS-003 discontinued subjects from May - October 2007).

Treatment and study plan

Primary outcomes

  1. Participants Survival Status as of the Time of the Extension Study Follow-up

    Time frame: up to 7 years

    Count of participants who were alive or deceased at the time of the extension study follow-up.

  2. Kaplan Meier Estimate for Overall Survival

    Time frame: up to 7 years

    Overall survival was measured from the start of therapy in CC-5013-MDS-003 to the date of death from any cause. Results include data collected during the extension follow-up.

  3. Participants Status Regarding Progression to Acute Myeloid Leukemia (AML) as of the Time of the Extension Study Follow-up

    Time frame: up to 7 years

    Count of participants who progressed to AML at the time of the extension study follow-up.

  4. Kaplan Meier Estimate for Progression to Acute Myeloid Leukemia (AML)

    Time frame: up to 7 years

    Progression to AML was measured from the start of therapy in CC-5013-MDS-003 to the date AML was diagnosed. Results include data collected during the extension follow-up.

  5. Cause of Death for Participants Who Died

    Time frame: up to 7 years

    Summary of the cause of death for participants from MDS-003 who died as of the time of the extension study follow-up.

Sponsors and collaborators

Lead sponsor

Celgene

Industry

Registry information

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Apr 6, 2010
Registry last updated
Nov 19, 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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.