Safety of Zileuton (Zyflo) in Combination With Imatinib Mesylate (Gleevec) in CML.

Stopped early · Phase 1

Conditions studied: Chronic Myelogenous Leukemia

In brief

The leukemic stem cells (LSCs) are cells that self- renew and give rise to leukemia. Eradication of LSC is required for cure. In chronic myelogenous leukemia (CML) LSCs are not eradicated by imatinib (Gleevec) alone. Recent discovery by Dr. Shaoguang Li at University of Massachusetts indicates that the LSCs can be targeted by a new drug zileuton (Chen et al. Nature Genetics 2009; 41:783-792). Zileuton (approved for asthma) will be tested in a combination with Gleevec. This combination has not been used previously to treat leukemia. This is a Phase I study. The goal of this research is to evaluate the safety of the standard anti-cancer drug imatinib and experimental drug zileuton.

Key facts

Study ID

NCT01130688

Run by

University of Massachusetts, Worcester

People needed

2

Starts

2010-01-01

Expected to finish

2014-12-01

Last updated by the study team

2015-05-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients with CML in chronic phase (patients already on imatinib)
• Presence of Philadelphia chromosome or bcr-abl rearrangement
• Age ≥ 18 years
• ECOG performance status ≤ 2
• Written informed consent

You may not qualify if…

• Hepatic dysfunction (serum bilirubin ≥ 2 x ULN, and/or ALT ≥ 3 x ULN, and/or AST ≥ 3 x ULN)
• Renal dysfunction (creatinine ≥ 200 μmol/l or 2.3 mg/dl)
• Severe cardiac dysfunction (NYHA classification III-IV)
• Severe pulmonary or neurologic disease
• Pregnant or lactating females
• Patients with a history of active malignancy during the past 5 years with the exception of nonmetastatic skin cancer (e.g. treated squamous or basal cell carcinoma) or stage 0 cervical carcinoma
• Patients known to be HIV-positive
• Patients with active, uncontrolled infections
• Male and female patients of reproductive potential who are not practicing effective means of contraception
• Patients with known allergic reaction or intolerance to either imatinib or zileuton
• Patients requiring anticoagulation therapy with coumadin

Where it is running

• University of Massachusetts Medical School — Worcester, Massachusetts, United States

Full record on ClinicalTrials.gov

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