Overview

Study of Lonafarnib and Gleevec in Chronic Myelogenous Leukemia

Status:
Completed
Trial end date:
2006-04-10
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this study if to investigate the effect of lonafarnib (SCH66336) in combination with Gleevec in the treatment of CML.
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
M.D. Anderson Cancer Center
Treatments:
Imatinib Mesylate
Lonafarnib
Criteria
1. Patients with Philadelphia chromosome (ph) positive CML in any of the following
categories:

1. Chronic phase patients must have failed therapy with Gleevec. Failure will be
defined as: (i) Patients who have not achieved or have lost their hematologic
response at 3 months from the start of therapy with Gleevec, or (ii) Patients who
have not achieved or have lost their cytogenetic response after 6 months of
therapy with Gleevec, or (iii) Patients who have not achieved or have lost their
major cytogenetic response after 12 months of therapy with Gleevec.

2. Patients in accelerated phase, defined as the presence of any of the following
features: (i) blasts in peripheral blood (PB) or bone marrow (BM) >/= 15% (but <
30%), (ii) blasts + promyelocytes in PB or BM >/= 30%, (iii) basophils in PB or
BM >/= 20%, (iv) platelets < 100 x 10e9/L unrelated to therapy, (v) clonal
evolution.

3. Patients in blast phase, defined by the presence of >/= 30% blasts in peripheral
blood and/or bone marrow, or the presence of extramedullary disease.

2) Patients in accelerated or blastic phase are eligible whether they have
received and/or failed Gleevec or not.

3) Age >/= 16 years.

4) Patients must sign an informed consent indicating that they are aware of the
investigational nature of this study in keeping eith the policies of the
hospital. The only acceptable consent form is attached at the end of the
protocol.

5) Performance status
6) Patients must have adequate hepatic functions (bilirubin renal functions (creatinine
7) Exclusion criteria:

1. Patients with QTc > 500 msec.

2. Patients with severe heart disease (cardiac class III and IV) will be excluded.