Cancer Clinical Trial
Official title:
A Phase II Study of Gleevec and Arsenic Trioxide in Patients With CML Who Fail to Achieve a Complete Response to Initial Gleevec Treatment
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.
- Chronic myelogenous leukemia (CML) results from the clonal expansion of immature
myeloid cells with the t (9,22) (Ph) translocation, that encodes the constitutively
active tyrosine kinase oncogene, bcr/abl. Patients with chronic phase CML are currently
being treated with either hemopoetic stem cell transplantation (HSCT), or with the
recently approved tyrosine kinase inhibitor, imatinib. Previous data, using interferon
in patients with CML, has shown that patients who do not achieve a major cytogenetic
response (defined as >35% Ph+) have a shortened survival. These patients are often
considered for HSCT. However, due to constraints of age, suitable donor, and patient
choice, only a minority of patients will undergo this potentially curative procedure.
- The aim of this study is to create a uniform approach to the treatment of CML in New
Mexico, with an aim of achieving complete cytogenetic response as the primary goal. A
graded approach will be taken, starting out with the standard treatment (imatinib 400
mg per day), and then in patients identified as poor responders an imatinib, and
arsenic combination will be offered to patients. It is hoped to find a complete
cytogenetic response that exceeds the ~20% response with gleevec 800mg per day.
;
Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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