A Study to Access the Safety/Efficacy of Thalidomide in the Treatment of Anemia in Patients With Myelodysplastic Syndromes

June 23, 2005 updated by: Celgene Corporation
The primary objective of the study is to determine the efficacy of thalidomide for the treatment of anemia in patients with myelodysplastic syndromes (MDS).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
220

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • La Jolla, California, United States, 93037
        • Scripps Cancer Center
      • Palm Springs, California, United States, 92262
        • Comprehensive Cancer Centers of the Desert
      • Rancho Mirage, California, United States, 92270
        • Desert Hematology Oncology Medical Group Inc
    • Connecticut
      • Norwalk, Connecticut, United States, 06856
        • Whittingham Cancer Center
      • West Haven, Connecticut, United States, 06516
        • VA Connecticut Healthcare System
    • Florida
      • Fort Myers, Florida, United States, 33901
        • Florida Cancer Specialists
      • Ft. Lauderdale, Florida, United States, 33308
        • Southeast Florida Hematology-Oncology
    • Illinois
      • Arlington Heights, Illinois, United States, 60004
        • Northwest Medical Specialists
    • Iowa
      • Cedar Rapids, Iowa, United States, 52403
        • Oncology Associates
    • Michigan
      • Royal Oak, Michigan, United States, 48073
        • Beaumont Cancer Center
    • Minnesota
      • Duluth, Minnesota, United States, 55805
        • SMDC Health Systems
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic
    • Mississippi
      • Jackson, Mississippi, United States, 39202
        • Jackson Oncology Associates PLLC
    • Missouri
      • St. Louis, Missouri, United States, 63136
        • Hematology Oncology Consultants Inc
    • Nevada
      • Las Vegas, Nevada, United States, 89106
        • Southern Nevada Cancer Research Foundation
    • New Jersey
      • Paramus, New Jersey, United States, 07652
        • Hematology Oncology Associates of NJ
      • Summit, New Jersey, United States, 07901
        • Summit Medical Group/Overlook Oncology Center
    • New York
      • Buffalo, New York, United States, 14263
        • Roswell Park Cancer Institute
      • New York, New York, United States, 10021
        • Memorial Sloan Kettering Cancer Ctr
      • Northport, New York, United States, 11768
        • VAMC Northport
      • Rochester, New York, United States, 14642
        • University of Rochester Cancer Center
      • Rockville Centre, New York, United States, 11570
        • South Shore Hem-Onc Assoc. PA
      • Staten Island, New York, United States, 10305
        • Staten Island Unversity Hospital
      • Valhalla, New York, United States, 10595
        • Westchester County Medical Center
      • Williamsville, New York, United States, 14221
        • Buffalo Medical Group PC
    • North Carolina
      • Hickory, North Carolina, United States, 28602
        • Northwestern Carolina Hematology Oncology PA
      • Winston Salem, North Carolina, United States, 27157-1082
        • Wake Forest Univ School of Medicine
    • Ohio
      • Cincinnati, Ohio, United States, 45246
        • Oncology/Hematology Care Inc
    • Oregon
      • Portland, Oregon, United States, 97201
        • Oregon Health & Science University
    • Pennsylvania
      • Kingston, Pennsylvania, United States, 18704
        • Medical Oncology Associates
      • Lancaster, Pennsylvania, United States, 17605
        • Lancaster Cancer Center LTD
      • Philadelphia, Pennsylvania, United States, 19129
        • MCP Hahnemann University
      • Pittsburgh, Pennsylvania, United States, 15224
        • Western Pennsylvania Cancer Institute
    • Texas
      • Dallas, Texas, United States, 75230
        • Texas Oncology PA-BMT Center
    • Utah
      • Provo, Utah, United States, 84604
        • Central Utah Medical Clinic
      • Salt Lake City, Utah, United States, 84122
        • InterMountain Hematology/Oncology
    • Washington
      • Seattle, Washington, United States, 98104
        • Swedish Cancer Institute
      • Yakima, Washington, United States, 98902
        • Yakima Regional CancerCenter

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

  • Eligible patients must have a diagnosis of myelodysplastic syndrome
  • Life expectancy of at least 6 months.
  • Patients must be able to adhere to the study visit schedule and other protocol requirements.
  • Patients must understand and voluntarily sign an informed consent document.
  • Women of childbearing potential (WCBP) must agree to practice abstinence or to use TWO methods of contraception beginning 4 weeks prior to the start of study medication and throughout the course of treatment.
  • Males must use barrier contraception when engaging in reproductive sexual activity with women of childbearing potential.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Celgene Corporation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2001

Study Completion

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2004

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 23, 2002

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 23, 2002

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 24, 2002

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 24, 2005

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 23, 2005

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2004

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • THAL-MDS-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings