A Phase II Study of Gleevec and Arsenic Trioxide in Patients With CML Who Fail Gleevec
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.
|Study Design:||Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|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|
- To test the activity of arsenic trioxide in combination with imatinib in patients with CML with cytogenetic evidence of residual disease [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
- To determine the toxicity associated with this therapy [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
|Study Start Date:||April 2004|
|Study Completion Date:||March 2006|
|Primary Completion Date:||April 2005 (Final data collection date for primary outcome measure)|
Drug: Gleevec and Arsenic Trioxide
- 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.
|United States, New Mexico|
|University of New Mexico|
|Albuquerque, New Mexico, United States, 87131|
|New Mexico Cancer Care Associates|
|Santa Fe, New Mexico, United States, 87505|
|Principal Investigator:||Ian Rabinowitz, MD||University of New Mexico|