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

Completed · Phase 3

Conditions studied: Leukemia, Myeloid, Chronic

In brief

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.

Key facts

Study ID

NCT00050531

Run by

M.D. Anderson Cancer Center

People needed

94

Starts

2003-04-01

Expected to finish

2015-08-01

Last updated by the study team

2016-05-11

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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).
• Eastern Cooperative Oncology Group (ECOG) performance of 0-2.
• 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
• Signed informed consent.

You may not qualify if…

• New York Heart Association (NYHA) cardiac class 3-4 heart disease.
• Psychiatric disability (psychosis)
• Pregnant or lactating females
• Late chronic phase, accelerated or blastic phase

Where it is running

• University of Texas MD Anderson Cancer Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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