A Pilot Study of Imatinib Mesylate in Steroid Refractory Chronic Graft Versus Host Disease

Phase 1

Completed

• Conditions: Graft vs Host Disease
• Interventions: Drug: Imatinib

• Registration Number: NCT00760981
• Lead Sponsor: David Miklos

Brief Summary

To determine if subjects with steroid refractory cGVHD can tolerate imatinib mesylate and whether their cGVHD responds to imatinib mesylate.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-09
• Study First Submitted: 2008-09-25
• Study First Submitted QC: 2008-09-25
• Study First Posted: 2008-09-26
• Primary Completion: 2012-04
• Study Completion: 2012-04
• Status Verified: 2020-04
• Last Update Submitted: 2020-04-13
• Last Update Posted: 2020-04-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Imatinib	Imatinib	200 mg orally daily and 400 mg orally daily for 4 weeks.

Primary Outcome Measures

Name	Time	Method
The frequency of adverse events graded according to the CTCAE will be the primary endpoint	Subjects will be monitored at 1, 4, 8, 16, and 24 weeks.

Trial Locations

Locations (2)

Stanford University School of Medicine; 🇺🇸 Stanford, California, United States

Fred Hutchinson Cancer Research Center (FHCRC); 🇺🇸 Seattle, Washington, United States