Thalidomide at Low Dose for the Treatment of Patient With Myelodysplastic Syndromes - THAL-SMD-200

April 3, 2007 updated by: Groupe Francophone des Myelodysplasies

Thalidomide for the Treatment of Cytopenias of Patients With Low Risk Myelodysplastic Syndromes

The GFM previously conducted a dose-escalating phase II trial of thalidomide in MDS with a minimum dose of 200mg/d and a maximum dose 800mg/d. Responses were evaluated according to IWG criteria at week 16 and thalidomide continued up to week 56 in responders. 82% patients received at least 8 weeks of treatment and were evaluable. 59% had hematological improvement, mainly on the erythroid lineage (Increase of Hemoglobin). Most responses were observed at low doses and between 4 and 8 weeks.

The objectives of this trial (Thal-SMD-20) are to evaluate the efficacy and tolerance of lower doses thalidomide in low risk MDS patients with transfusion-dependant anemia.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Thalidomide:

First part of the trial: 82 patients at 200mg/day given at bedtime x 12 weeks, decreased to 100mg/day if grade 1 or 2 side. Stopped temporally for 1 week if grade 3 or 4 side effects. Then reintroduced at the same dose. If side effects again, definitively stopped.

Responses evaluated at 12 weeks according to IWG criteria for the erythroid lineage

At week 12:

  • If no Hematological improvement (HI): increased to 300mg/day for 8 weeks and then eventually to 400mg/day for 8 weeks more, if no HI.
  • If Hematological improvement (HI): continued at the same dose.

Second part of the trial: 30 patients treated at 50mg/day x 12 weeks. Responses evaluated at 12 weeks according to IWG criteria for the erythroid lineage

At week 12:

  • If no Hematological improvement (HI): increased to 100mg/day for 8 weeks and then eventually to 200mg/day for 8 weeks more, if no HI.
  • If Hematological improvement (HI): continued at the same dose.

Study Type

Interventional

Enrollment

112

Phase

  • Phase 2

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

  • France
      • Angers, France, 49 033
        • CHU d'Angers
      • Avignon, France, 84 000
        • CH d'Avignon
      • Bayonne, France, 64 100
        • CH de la Cote Basque
      • Bobigny, France, 93009
        • Hôpital Avicenne
      • Brest, France, 29 609
        • Chu de Brest - Hôpital Morvan
      • Dijon, France, 21 000
        • CHU Dijon
      • Grenoble, France, 38 043
        • CHU Albert Michallon
      • Lille, France, 59037
        • CHRU de Lille - Hôpital C. Huriez
      • Limoges, France, 87 042
        • CHU de Limoges
      • Marseille, France, 13009
        • Institut Paoli Calmette
      • Nantes, France, 44 093
        • CHU de Nantes
      • Nice, France, 06 202
        • CHU de Nice - Hôpital de l'Archet 1
      • Paris, France, 75014
        • Hôpital COCHIN
      • Paris, France, 75015
        • Hôpital Necker
      • Paris, France, 75 004
        • Hotel Dieu
      • Paris, France, 75 012
        • Hopital Saint Antoine
      • Perpignan, France, 66 046
        • CH Joffre
      • Rouen, France, 76 038
        • Centre Henry Becquerel
      • Toulouse, France, 31059
        • CHU Purpan
      • Vandoeuvre les Nancy, France, 54511
        • CHU Nancy-Brabois

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

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients ≥18 years, with IPSS Low or Int-1 MDS
  • Transfusion dependant anemia above 2 packed red blood cells (PRBC)/month
  • ECOG index = 0, 1, 2
  • No peripheral neurological disease

Exclusion Criteria:

  • MDS patients with IPSS Int-2 or High
  • Patients with less than 2 packed red blood cells (PRBC)/month
  • Patients with previous history of venous thrombosis
  • Patient treated with EPO +/- G-CSF in the 2 months before inclusion in the protocol
  • Patient having received intensive chemotherapy in the 3 months before inclusion in the protocol
  • Patient having received Thalidomide in a previous protocol
  • Patient presenting an iron, B12 vitamin or folic acid uncorrected deficiency
  • Patient with peripheral neurological disease
  • Patient not being able to subject itself to a regular clinical and biological follow-up
  • Pregnant patient or patient in a period of lactation
  • Patient refusing to take a contraceptive treatment through out all the study
  • Patient receiving drugs able to interfere with the mechanism of action of Thalidomide
  • Patient refusing to sign the informed consent.

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: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Efficacy evaluated at week 12 according to the IWG criterias

Secondary Outcome Measures

Outcome Measure
Safety

Collaborators and Investigators

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

Sponsor

Groupe Francophone des Myelodysplasies

Investigators

  • Principal Investigator: Didier Bouscary, MD, Ph-D, Groupe Francophone des Myelodysplasies

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

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

January 1, 2003

Study Completion (Actual)

March 1, 2007

Study Registration Dates

First Submitted

April 3, 2007

First Submitted That Met QC Criteria

April 3, 2007

First Posted (Estimate)

April 4, 2007

Study Record Updates

Last Update Posted (Estimate)

April 4, 2007

Last Update Submitted That Met QC Criteria

April 3, 2007

Last Verified

April 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 020895
  • CCPPRB Cochin 2402-1-1928

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.

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