Late Chronic Phase Chronic Myelogenous Leukemia

• Status: Completed
• Trial end date: 2013-09-01
• Target enrollment: 0
• Participant gender: All

Summary

Objectives:

Primary endpoints:

To achieve low levels of Polymerase Chain Reaction (PCR) ratios of B-cell antigen receptor (Bcr-Abl)/Bcr (molecular CR) in a significant proportion of patients after 12 months of higher doses (800 mg daily) of Gleevec therapy To increase the proportion of patients achieving a complete cytogenetic response in patients with Ph-positive chronic phase CML using initial higher dose Gleevec therapy.

Secondary endpoints:

To evaluate the durations of PCR negativity, cytogenetic response, hematologic control, and survival.

To analyze differences in response rates and in prognosis within different risk groups and patient characteristics

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: M.D. Anderson Cancer Center
• Treatments: Imatinib Mesylate

Criteria

Inclusion Criteria:

1. Patients age 15 years or older with a diagnosis of Ph-positive or Bcr-positive CML in chronic phase CML. They should be in at least one of the categories below: A. Patients must have received interferon alpha and: - Failed to achieve or lost a hematologic complete remission(after 3 months of therapy with interferon), or - Failed to achieve or lost a major cytogenetic remission, or - Failed to achieve or lost a complete molecular remission (competitive quantitative PCR <0.05%), or - Were intolerant to interferon B. Patients in late chronic phase (i.e., >/= 12 months from diagnosis) who have not received treatment with interferon and: - Have high risk for toxicity with IFN-A (e.g., age >/= 60 years), or - Refuse to use IFN-A

2. ECOG performance of 0-2.

3. Serum bilirubin less than 2mg%, serum creatinine less than 2mg%.

Exclusion Criteria:

1. - NYHA Class 3-4 heart disease; Pregnant or lactating females

2. Women of pregnancy potential must practice contraception

3. Patients in accelerated phase (except clonal evolution) or blastic phase are excluded.

• Patients with clonal evolution as their only criterion for accelerated phase are eligible.

4. Inclusion of women and minorities: As per NIH policy, women and members of minorities will be included in this protocol as they are referred in the CML population.