Ontak (Denileukin Diftitox) in Patients With Systemic Mastocytosis (SM)
Completed · Phase 2
Conditions studied: Leukemia, Systemic Mastocytosis
In brief
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.
Key facts
- Study ID
- NCT00493129
- Run by
- M.D. Anderson Cancer Center
- People needed
- 8
- Starts
- 2004-07-01
- Expected to finish
- 2007-08-01
- Last updated by the study team
- 2012-02-08
Who can join
Age: any. Sex: any. Healthy volunteers: not accepted.
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.
Where it is running
- The University of Texas M.D. Anderson Cancer Center — Houston, Texas, United States
Full record on ClinicalTrials.gov
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