Thalidomide in Treating Patients With Relapsed or Progressive Systemic Mastocytosis
RATIONALE: Thalidomide may stop the growth of systemic mastocytosis by blocking blood flow to the disease.
PURPOSE: This phase II trial is studying how well thalidomide works in treating patients with relapsed or progressive systemic mastocytosis.
Non Neoplastic Condition
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Study of Thalidomide in Mastocytosis|
- Objective reduction of the infiltration rate at 6 months [ Time Frame: 6 months ] [ Designated as safety issue: No ]
|Study Start Date:||June 2007|
|Study Completion Date:||October 2012|
|Primary Completion Date:||May 2011 (Final data collection date for primary outcome measure)|
- Determine the objective response rate at 6 months in patients with systemic mastocytosis treated with thalidomide.
- Determine the tolerability of this drug in these patients.
OUTLINE: This is a multicenter study.
Patients receive oral thalidomide once daily for 6 months in the absence of disease progression.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00769587
|Centre Hospitalier Universitaire d'Amiens|
|Amiens, France, 80054|
|Study Chair:||Gandhi Damaj||Centre Hospitalier Universitaire, Amiens|