NCT00455910

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
112

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jan 2003

Typical duration for phase_2

Geographic Reach
1 country

20 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2003

Completed
4.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2007

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 3, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 4, 2007

Completed
Last Updated

April 4, 2007

Status Verified

April 1, 2007

First QC Date

April 3, 2007

Last Update Submit

April 3, 2007

Conditions

Myelodysplastic Syndromes

Keywords

Low risk myelodysplastic syndromesMDSBone marrow diseasesThalidomideCytopeniasAnemia

Outcome Measures

Primary Outcomes (1)

  • Efficacy evaluated at week 12 according to the IWG criterias

Secondary Outcomes (1)

  • Safety

Interventions

ThalidomideDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (20)

CHU d'Angers

Angers, 49 033, France

Location

CH d'Avignon

Avignon, 84 000, France

Location

CH de la Cote Basque

Bayonne, 64 100, France

Location

Hopital Avicenne

Bobigny, 93009, France

Location

CHU de Brest - Hopital Morvan

Brest, 29 609, France

Location

CHU Dijon

Dijon, 21 000, France

Location

CHU Albert Michallon

Grenoble, 38 043, France

Location

CHRU de Lille - Hopital C. Huriez

Lille, 59037, France

Location

CHU de Limoges

Limoges, 87 042, France

Location

Institut Paoli Calmette

Marseille, 13009, France

Location

CHU de Nantes

Nantes, 44 093, France

Location

CHU de Nice - Hopital de l'Archet 1

Nice, 06 202, France

Location

Hotel Dieu

Paris, 75 004, France

Location

Hopital Saint Antoine

Paris, 75 012, France

Location

Hopital Cochin

Paris, 75014, France

Location

Hopital Necker

Paris, 75015, France

Location

CH Joffre

Perpignan, 66 046, France

Location

Centre Henry Becquerel

Rouen, 76 038, France

Location

CHU Purpan

Toulouse, 31059, France

Location

CHU Nancy-Brabois

Vandœuvre-lès-Nancy, 54511, France

Location

Related Publications (1)

  • Bouscary D, Legros L, Tulliez M, Dubois S, Mahe B, Beyne-Rauzy O, Quarre MC, Vassilief D, Varet B, Aouba A, Gardembas M, Giraudier S, Guerci A, Rousselot P, Gaillard F, Moreau A, Rousselet MC, Ifrah N, Fenaux P, Dreyfus F; Groupe Francais des Myelodysplasies (GFM). A non-randomised dose-escalating phase II study of thalidomide for the treatment of patients with low-risk myelodysplastic syndromes: the Thal-SMD-2000 trial of the Groupe Francais des Myelodysplasies. Br J Haematol. 2005 Dec;131(5):609-18. doi: 10.1111/j.1365-2141.2005.05817.x.

    PMID: 16351636BACKGROUND

Related Links

MeSH Terms

Conditions

Myelodysplastic SyndromesBone Marrow DiseasesCytopeniaAnemia

Interventions

Thalidomide

Condition Hierarchy (Ancestors)

Hematologic DiseasesHemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

PhthalimidesPhthalic AcidsAcids, CarbocyclicCarboxylic AcidsOrganic ChemicalsPiperidonesPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsIsoindolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Didier Bouscary, MD, Ph-D

    Groupe Francophone des Myelodysplasies

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 3, 2007

First Posted

April 4, 2007

Study Start

January 1, 2003

Study Completion

March 1, 2007

Last Updated

April 4, 2007

Record last verified: 2007-04

Locations

FR(20)