Overview

High-Dose Gleevec Alone or in Combination With Peg-Intron and GM-CSF in Early Phase Chronic Myelogenous Leukemia (CML)

Status:
Completed
Trial end date:
2015-08-01
Target enrollment:
0
Participant gender:
All
Summary
The goal of this clinical research study is to learn if giving PEG-Alpha Interferon (PEG-Intron) and Sargramostim (GM-CSF) to patients receiving treatment with high dose Gleevec (imatinib mesylate) is more effective in treating CML in chronic phase than therapy with imatinib mesylate alone.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
M.D. Anderson Cancer Center
Collaborator:
Novartis
Treatments:
Imatinib Mesylate
Interferon alpha-2
Interferon-alfa-1b
Interferon-alpha
Interferons
Molgramostim
Peginterferon alfa-2b
Sargramostim
Criteria
Inclusion Criteria:

1. Patients with Ph-positive CML in early chronic phase CML who have received no or
minimal prior therapy, (<1 month of prior IFN-alpha (with or without ara-C) and/or
Gleevec).

2. Eastern Cooperative Oncology Group (ECOG) performance of 0-2.

3. Adequate end organ function, defined as the following: total bilirubin < 1.5 x upper
limit of normal (ULN), serum glutamate pyruvate transaminase (SGPT) < 2.5 x ULN,
creatinine < 1.5 x ULN

4. Signed informed consent.

Exclusion Criteria:

1. New York Heart Association (NYHA) cardiac class 3-4 heart disease.

2. Psychiatric disability (psychosis)

3. Pregnant or lactating females

4. Late chronic phase, accelerated or blastic phase