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Late Chronic Phase Chronic Myelogenous Leukemia

NCT01092741 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 47

Last updated 2016-05-11

No results posted yet for this study

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

Conditions

Interventions

DRUG

Gleevec

400 mg P.O. twice daily (800 mg total daily dose)

Sponsors & Collaborators

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Jorge E Cortes, MD · The University Of MD Anderson Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
15 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2001-07-31
Primary Completion
2006-12-31
Completion
2013-09-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01092741 on ClinicalTrials.gov