Ontak (Denileukin Diftitox) in Patients With Systemic Mastocytosis (SM)

NCT00493129 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2012-02-08

No results posted yet for this study

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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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00493129 on ClinicalTrials.gov