Thalidomide in Treating Patients With Relapsed or Progressive Systemic Mastocytosis

Phase 2

Completed

• Conditions: Non Neoplastic Condition; Precancerous Condition
• Interventions: Drug: thalidomide

• Registration Number: NCT00769587
• Lead Sponsor: Centre Hospitalier Universitaire, Amiens

Brief Summary

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.

Detailed Description

OBJECTIVES:

Primary

* Determine the objective response rate at 6 months in patients with systemic mastocytosis treated with thalidomide.

Secondary

* 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.

Study Timeline

• Study Start: 2007-06
• Study First Submitted: 2008-10-08
• Study First Submitted QC: 2008-10-08
• Study First Posted: 2008-10-09
• Primary Completion: 2011-05
• Study Completion: 2012-10
• Status Verified: 2016-04
• Last Update Submitted: 2016-04-25
• Last Update Posted: 2016-04-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Thalidomide	thalidomide	Use of thalidomide

Primary Outcome Measures

Name	Time	Method
Objective reduction of the infiltration rate at 6 months	6 months

Trial Locations

Locations (1)

Centre Hospitalier Universitaire d'Amiens; 🇫🇷 Amiens, France