NCT00493129

Brief Summary

Primary Objective: 1\. To assess the response rate of ONTAK in Systemic Mastocytosis (SM) patients. Secondary Objectives:

  1. 1.To assess the safety of ONTAK in SM patients.
  2. 2.To evaluate the time to progression and duration of response following treatment with ONTAK.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for phase_2 leukemia

Timeline
Completed

Started Jul 2004

Shorter than P25 for phase_2 leukemia

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2004

Completed
3 years until next milestone

First Submitted

Initial submission to the registry

June 26, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 28, 2007

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2007

Completed
Last Updated

February 8, 2012

Status Verified

February 1, 2012

Enrollment Period

3.1 years

First QC Date

June 26, 2007

Last Update Submit

February 7, 2012

Conditions

LeukemiaSystemic 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
  • Adequate renal function (indicated by serum creatinine \</= 2.5 mg/dL); adequate hepatic function (indicated by ALT \</= 3 \* upper limit of normal; total bilirubin \</= 3 \* upper limit of normal; and albumin \>/= 2.8 g/dL).
  • Provide written informed consent.
  • Female patients of childbearing potential must have a negative pregnancy test within 14 days prior to first dose of study drug, and must agree to use an effective means of contraception following the pregnancy test, throughout the study and for at least three weeks after their last treatment on protocol.

You may not qualify if:

  • History of hypersensitivity to diphtheria toxin.
  • Active cardiovascular disease as defined by New York Heart Association (NYHA) Class III-IV categorization.
  • Serious intercurrent medical illnesses or active infections requiring parenteral antibiotics that would interfere with the ability of the patient to carry out the treatment program.
  • Concurrent malignancy (other than resected basal or squamous cell skin cancers or in-situ cervical cancer). Unless, patient has SM-associated clonal hematologic disease that does not require therapy, as judged by treating physician and approved by principal investigator.
  • Female patients who are pregnant or breastfeeding.
  • No chemotherapy, radiotherapy, immunotherapy, hormonal anticancer therapy, or experimental medications (including approved drugs tested in an investigational setting) may be administered while a patient is a participant in this protocol.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of Texas M.D. Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

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, AcuteLeukemia, Myeloid

Study Officials

  • Srdan Verstovsek, MD

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

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 1, 2004

Primary Completion

August 1, 2007

Study Completion

August 1, 2007

Last Updated

February 8, 2012

Record last verified: 2012-02

Locations

US(1)