Skip to main content
OpenTrials
Completed

NCT Number: NCT00455910

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Myelodysplastic Syndromes Anemia Bone Marrow Diseases Cytopenia Hematologic Diseases Hemic and Lymphatic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

CHU d'Angers, Angers, France

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

thalidomide

Drug

Primary outcomes

  1. Efficacy evaluated at week 12 according to the IWG criterias

Secondary outcomes

  1. Safety

Sponsors and collaborators

Lead sponsor

Groupe Francophone des Myelodysplasies

Other

Registry information

Official study title

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

Important dates

Study start
2003
Study completion
2007
First posted
Apr 4, 2007
Registry last updated
Apr 4, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.