Ontak (Denileukin Diftitox) in Patients With Systemic Mastocytosis (SM)
NCT00493129 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 8
Last updated 2012-02-08
Summary
Primary Objective:
1\. To assess the response rate of ONTAK in Systemic Mastocytosis (SM) patients.
Secondary Objectives:
1. To assess the safety of ONTAK in SM patients.
2. To evaluate the time to progression and duration of response following treatment with ONTAK.
Conditions
Interventions
- DRUG
-
Ontak (Denileukin Diftitox)
9 µg/kg by vein Days 1-5 of a 21 day cycle.
Sponsors & Collaborators
-
M.D. Anderson Cancer Center
lead OTHER
Principal Investigators
-
Srdan Verstovsek, MD · M.D. Anderson Cancer Center
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2004-07-31
- Primary Completion
- 2007-08-31
- Completion
- 2007-08-31
Countries
- United States
Study Locations
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