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

This study has been completed.
Sponsor:
Information provided by:
Groupe Francophone des Myelodysplasies
ClinicalTrials.gov Identifier:
NCT00455910
First received: April 3, 2007
Last updated: NA
Last verified: April 2007
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Myelodysplastic Syndromes
Drug: Thalidomide
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Thalidomide for the Treatment of Cytopenias of Patients With Low Risk Myelodysplastic Syndromes

Resource links provided by NLM:


Further study details as provided by Groupe Francophone des Myelodysplasies:

Primary Outcome Measures:
  • Efficacy evaluated at week 12 according to the IWG criterias

Secondary Outcome Measures:
  • Safety

Estimated Enrollment: 112
Study Start Date: January 2003
Study Completion Date: March 2007
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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00455910

Locations
France
CHU d'Angers
Angers, France, 49 033
CH d'Avignon
Avignon, France, 84 000
CH de la Cote Basque
Bayonne, France, 64 100
Hopital Avicenne
Bobigny, France, 93009
CHU de Brest - Hopital Morvan
Brest, France, 29 609
CHU Dijon
Dijon, France, 21 000
CHU Albert Michallon
Grenoble, France, 38 043
CHRU de Lille - Hopital C. Huriez
Lille, France, 59037
CHU de Limoges
Limoges, France, 87 042
Institut Paoli Calmette
Marseille, France, 13009
CHU de Nantes
Nantes, France, 44 093
CHU de Nice - Hopital de l'Archet 1
Nice, France, 06 202
Hopital Necker
Paris, France, 75015
Hopital Cochin
Paris, France, 75014
Hopital Saint Antoine
Paris, France, 75 012
Hotel Dieu
Paris, France, 75 004
CH Joffre
Perpignan, France, 66 046
Centre Henry Becquerel
Rouen, France, 76 038
CHU Purpan
Toulouse, France, 31059
CHU Nancy-Brabois
Vandoeuvre les Nancy, France, 54511
Sponsors and Collaborators
Groupe Francophone des Myelodysplasies
Investigators
Principal Investigator: Didier Bouscary, MD, Ph-D Groupe Francophone des Myelodysplasies
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00455910     History of Changes
Other Study ID Numbers: 020895, CCPPRB Cochin 2402-1-1928
Study First Received: April 3, 2007
Last Updated: April 3, 2007
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Groupe Francophone des Myelodysplasies:
Low risk myelodysplastic syndromes
MDS
Bone marrow diseases
Thalidomide
Cytopenias
Anemia

Additional relevant MeSH terms:
Myelodysplastic Syndromes
Preleukemia
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions
Neoplasms
Thalidomide
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Leprostatic Agents
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents

ClinicalTrials.gov processed this record on July 22, 2014