A Phase II Study of Gleevec and Arsenic Trioxide in Patients With CML Who Fail Gleevec

Completed · Phase 2

Conditions studied: Leukemia, Other, Cancer

In brief

1.0 OBJECTIVES 1.1 To test the activity of arsenic trioxide in combination with imatinib in patients with CML with cytogenetic evidence of residual disease. 1.2 To determine the toxicity associated with this therapy.

Key facts

Study ID

NCT00250042

Run by

New Mexico Cancer Research Alliance

People needed

6

Starts

2004-04-01

Expected to finish

2006-03-01

Last updated by the study team

2011-09-20

Who can join

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

You may qualify if…

• All patients, 18 years of age or older, with a diagnosis of CML.
• Patients must have a life expectancy of at least 12 weeks.
• Patients must have an ECOG performance status of 0-2.
• Patients must sign an informed consent.
• Patients should have adequate hepatic function with a total bilirubin < 2 mg/dl and SGOT or SGPT < two times the upper limit of normal, and adequate renal function as defined by a serum creatinine < 1.5 x upper limit of normal.
• Patients with CML in chronic phase on gleevec as first line therapy who fulfill the following criteria:
• Failure to achieve a complete hematologic response (CHR) after 3 months of therapy (hematologic resistance)
• Failure to achieve a complete cytogenetic response (CGCR) after > 9 months of therapy.
• Cytogenetic relapse, defined as an increase in the Ph+ cells by at least 30%.
• Hematologic relapse defined as the appearance of any of the following, confirmed by a second determination > 1 month later:
• WBC count >20, 000,
• Platelet count >600,000,
• Progressive splenomegaly > 5 cm below the left intercostals margin,
• >5% myelocytes and/or metamyelocytes in the peripheral blood,
• Blasts or promyelocytes in the peripheral blood

You may not qualify if…

• Pregnant women or nursing mothers are not eligible for this trial. Patients of child bearing potential must use adequate contraception.
• Patients may receive no other concurrent chemotherapy or radiation therapy during this trial.
• Patients with severe medical problems such as uncontrolled diabetes mellitus or cardiovascular disease or active infections are not eligible for this trial.

Where it is running

• University of New Mexico — Albuquerque, New Mexico, United States
• New Mexico Cancer Care Associates — Santa Fe, New Mexico, United States

Full record on ClinicalTrials.gov

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