A Phase II Study of Gleevec and Arsenic Trioxide in Patients With CML Who Fail Gleevec
- Conditions
- Leukemia, OtherCancer
- Registration Number
- NCT00250042
- Lead Sponsor
- New Mexico Cancer Care Alliance
- Brief Summary
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.
- Detailed Description
* 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 6
Not provided
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method To test the activity of arsenic trioxide in combination with imatinib in patients with CML with cytogenetic evidence of residual disease 2 years
- Secondary Outcome Measures
Name Time Method To determine the toxicity associated with this therapy 2 years
Trial Locations
- Locations (2)
New Mexico Cancer Care Associates
🇺🇸Santa Fe, New Mexico, United States
University of New Mexico
🇺🇸Albuquerque, New Mexico, United States