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


Phase 2
18 Years
N/A
Not Enrolling
Both
Myelodysplastic Syndromes

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Trial Information

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


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.


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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Efficacy evaluated at week 12 according to the IWG criterias

Principal Investigator

Didier Bouscary, MD, Ph-D

Investigator Role:

Principal Investigator

Investigator Affiliation:

Groupe Francophone des Myelodysplasies

Authority:

France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:

020895

NCT ID:

NCT00455910

Start Date:

January 2003

Completion Date:

March 2007

Related Keywords:

  • Myelodysplastic Syndromes
  • Low risk myelodysplastic syndromes
  • MDS
  • Bone marrow diseases
  • Thalidomide
  • Cytopenias
  • Anemia
  • Myelodysplastic Syndromes
  • Preleukemia

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