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

Primary Purpose

Myelodysplastic Syndromes

Status
Completed
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
Thalidomide
Sponsored by
Groupe Francophone des Myelodysplasies
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myelodysplastic Syndromes focused on measuring Low risk myelodysplastic syndromes, MDS, Bone marrow diseases, Thalidomide, Cytopenias, Anemia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • CHU d'Angers
  • CH d'Avignon
  • CH de la Cote Basque
  • Hopital Avicenne
  • CHU de Brest - Hopital Morvan
  • CHU Dijon
  • CHU Albert Michallon
  • CHRU de Lille - Hopital C. Huriez
  • CHU de Limoges
  • Institut Paoli Calmette
  • CHU de Nantes
  • CHU de Nice - Hopital de l'Archet 1
  • Hotel Dieu
  • Hopital Saint Antoine
  • Hopital Cochin
  • Hopital Necker
  • CH Joffre
  • Centre Henry Becquerel
  • CHU Purpan
  • CHU Nancy-Brabois

Outcomes

Primary Outcome Measures

Efficacy evaluated at week 12 according to the IWG criterias

Secondary Outcome Measures

Safety

Full Information

First Posted
April 3, 2007
Last Updated
April 3, 2007
Sponsor
Groupe Francophone des Myelodysplasies
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1. Study Identification

Unique Protocol Identification Number
NCT00455910
Brief Title
Thalidomide at Low Dose for the Treatment of Patient With Myelodysplastic Syndromes - THAL-SMD-200
Official Title
Thalidomide for the Treatment of Cytopenias of Patients With Low Risk Myelodysplastic Syndromes
Study Type
Interventional

2. Study Status

Record Verification Date
April 2007
Overall Recruitment Status
Completed
Study Start Date
January 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
March 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Groupe Francophone des Myelodysplasies

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myelodysplastic Syndromes
Keywords
Low risk myelodysplastic syndromes, MDS, Bone marrow diseases, Thalidomide, Cytopenias, Anemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
112 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Thalidomide
Primary Outcome Measure Information:
Title
Efficacy evaluated at week 12 according to the IWG criterias
Secondary Outcome Measure Information:
Title
Safety

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Didier Bouscary, MD, Ph-D
Organizational Affiliation
Groupe Francophone des Myelodysplasies
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU d'Angers
City
Angers
ZIP/Postal Code
49 033
Country
France
Facility Name
CH d'Avignon
City
Avignon
ZIP/Postal Code
84 000
Country
France
Facility Name
CH de la Cote Basque
City
Bayonne
ZIP/Postal Code
64 100
Country
France
Facility Name
Hopital Avicenne
City
Bobigny
ZIP/Postal Code
93009
Country
France
Facility Name
CHU de Brest - Hopital Morvan
City
Brest
ZIP/Postal Code
29 609
Country
France
Facility Name
CHU Dijon
City
Dijon
ZIP/Postal Code
21 000
Country
France
Facility Name
CHU Albert Michallon
City
Grenoble
ZIP/Postal Code
38 043
Country
France
Facility Name
CHRU de Lille - Hopital C. Huriez
City
Lille
ZIP/Postal Code
59037
Country
France
Facility Name
CHU de Limoges
City
Limoges
ZIP/Postal Code
87 042
Country
France
Facility Name
Institut Paoli Calmette
City
Marseille
ZIP/Postal Code
13009
Country
France
Facility Name
CHU de Nantes
City
Nantes
ZIP/Postal Code
44 093
Country
France
Facility Name
CHU de Nice - Hopital de l'Archet 1
City
Nice
ZIP/Postal Code
06 202
Country
France
Facility Name
Hotel Dieu
City
Paris
ZIP/Postal Code
75 004
Country
France
Facility Name
Hopital Saint Antoine
City
Paris
ZIP/Postal Code
75 012
Country
France
Facility Name
Hopital Cochin
City
Paris
ZIP/Postal Code
75014
Country
France
Facility Name
Hopital Necker
City
Paris
ZIP/Postal Code
75015
Country
France
Facility Name
CH Joffre
City
Perpignan
ZIP/Postal Code
66 046
Country
France
Facility Name
Centre Henry Becquerel
City
Rouen
ZIP/Postal Code
76 038
Country
France
Facility Name
CHU Purpan
City
Toulouse
ZIP/Postal Code
31059
Country
France
Facility Name
CHU Nancy-Brabois
City
Vandoeuvre les Nancy
ZIP/Postal Code
54511
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
16351636
Citation
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.
Results Reference
background
Links:
URL
http://www.gfmgroup.org
Description
website of French Group of Myelodysplasia

Learn more about this trial

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

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