Late Chronic Phase Chronic Myelogenous Leukemia

Completed · Phase 2

Conditions studied: Leukemia

In brief

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

Key facts

Study ID

NCT01092741

Run by

M.D. Anderson Cancer Center

People needed

47

Starts

2001-07-01

Expected to finish

2013-09-01

Last updated by the study team

2016-05-11

Who can join

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

You may qualify if…

• 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
• ECOG performance of 0-2.
• Serum bilirubin less than 2mg%, serum creatinine less than 2mg%.

You may not qualify if…

• - NYHA Class 3-4 heart disease; Pregnant or lactating females
• Women of pregnancy potential must practice contraception
• 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.
• 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.

Where it is running

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

Full record on ClinicalTrials.gov

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