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

PHASE2CompletedINTERVENTIONAL
Enrollment

6

Participants

Timeline

Start Date

April 30, 2004

Primary Completion Date

April 30, 2005

Study Completion Date

March 31, 2006

Conditions
Leukemia, OtherCancer
Interventions
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.

Trial Locations (2)

87131

University of New Mexico, Albuquerque

87505

New Mexico Cancer Care Associates, Santa Fe

All Listed Sponsors
lead

New Mexico Cancer Research Alliance

OTHER

NCT00250042 - A Phase II Study of Gleevec and Arsenic Trioxide in Patients With CML Who Fail Gleevec | Biotech Hunter | Biotech Hunter