Trials Sponsors Conditions Drugs Pricing

Conditions

Leukemia Systemic Mastocytosis

Keywords

Systemic MastocytosisSMMast Cell LeukemiaLeukemiaDenileukin DiftitoxOntak

Outcome Measures

Primary Outcomes (1)

Objective Response Rate
Bone marrow samples used to look at response to therapy collected every 3 months until disease progression or different therapy started. Clinical efficacy assessed as objective response (major and partial response) for responding patients analyzed by the Kaplan-Meier method.
3 months

Study Arms (1)

Ontak

EXPERIMENTAL

Ontak administered intravenously on Days 1-5 at the dose of 9 µg/kg/day, with a rest period from Days 6-21.

Drug: Ontak (Denileukin Diftitox)

Interventions

Ontak (Denileukin Diftitox)Drug

9 µg/kg by vein Days 1-5 of a 21 day cycle.

Also known as: Denileukin Diftitox

Ontak

Eligibility Criteria

Sexall

Healthy VolunteersNo

Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

Patients with SM, including mast cell leukemia (MCL).
ECOG Performance Status (PS) 0-3

Sponsors & Collaborators

M.D. Anderson Cancer Center
Otherlead

Study Sites (1)

The University of Texas M.D. Anderson Cancer Center

Houston, Texas, 77030, United States

MeSH Terms

Conditions

LeukemiaMastocytosis, SystemicLeukemia, Mast-Cell

Interventions

denileukin diftitox

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesMastocytosisNeoplasms, Connective TissueNeoplasms, Connective and Soft TissueMast Cell Activation DisordersImmune System DiseasesLeukemia, Myeloid, Acute

Study Officials

Srdan Verstovsek, MD
M.D. Anderson Cancer Center
PRINCIPAL INVESTIGATOR

Enrollment

8 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 2
Allocation: NA
Masking: NONE
Purpose: TREATMENT
Intervention Model: SINGLE GROUP
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

June 26, 2007

First Posted

June 28, 2007

Study Start

July 2004

Date type not reported

This date has not been verified as actual or estimated.

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Study Arms (1)

Ontak

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Links

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Study Arms (1)

Ontak

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Links

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations