Therapy of Early Chronic Phase CML With Gleevec

Completed · Phase 2

Conditions studied: Leukemia, Myeloid, Chronic-Phase

In brief

The goal of this clinical research study is to see if imatinib mesylate (Gleevec, STI571) can improve CML in chronic phase. Objectives: Primary Objective: To increase the proportion of patients achieving a complete cytogenetic response in patients with Ph-positive early chronic phase CML using initial Gleevec therapy. Secondary Objective: To evaluate the duration of cytogenetic response, duration of hematologic response and survival.

Key facts

Study ID

NCT00048672

Run by

M.D. Anderson Cancer Center

People needed

50

Starts

2001-03-01

Expected to finish

2013-08-01

Last updated by the study team

2016-01-20

Who can join

Age: 15 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosis of Philadelphia chromosome (Ph)- positive or breakpoint cluster region (bcr)-positive CML in early chronic (diagnosis < 12 months).
• Age 15 years or above
• Adequate renal, hepatic, cardiac and performance status (ECOG 0-2) - no psychiatric disability (psychosis)
• Signed informed consent

You may not qualify if…

• Grade 3-4 cardiac
• Psychiatric problem
• Pregnant or lactating

Where it is running

• UT MD Anderson Cancer Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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