NCT00250042

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

A Phase II Study of Gleevec and Arsenic Trioxide in Patients With CML Who Fail to Achieve a Complete Response to Initial Gleevec Treatment

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: New Mexico Cancer Research Alliance · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Leukemia, Other
• Cancer

Interventions

Type	Name	Description
DRUG	Gleevec and Arsenic Trioxide	Pts. who fit the inclusion criteria, \& were on imatinib, 400 mg/day, will be treated with a month of imatinib at 800 mg/d in divided doses (400mg bid) \& then started on arsenic trioxide. Pts. already on imatinib 800 mg/day may be started on arsenic trioxide. Pts. unable to tolerate 800 mg/d should be treated at the max. dose tolerated above 400 mg/d. A total of 16 weeks of arsenic trioxide treatment will be administered (15 weeks of maintenance). Pts. are to continue on imatinib 800 mg/day,(or the max. tolerated dose) while receiving the arsenic trioxide. If a pt. has been taken off the arsenic trioxide, they should be continued on gleevec 800 mg per day (or the maximum tolerated dose) until there is evidence of progression of disease.

Timeline

• Start date: 2004-04-01
• Primary completion: 2005-04-01
• Completion: 2006-03-01
• First posted: 2005-11-07
• Last updated: 2011-09-20

Locations

2 sites across 1 country: United States