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

NCT00050531 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 94

Last updated 2016-05-11

No results posted yet for this study

Summary

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.

Conditions

  • Leukemia, Myeloid, Chronic

Interventions

DRUG

Gleevec

400 mg orally twice daily.

DRUG

Peg-alpha interferon (Peg-Intron)

PEG-IFN 0.5 mcg/kg each week subcutaneously.

DRUG

Sargramostim (GM-CSF)

125 mcg/m\^2 three times per week subcutaneously.

Sponsors & Collaborators

  • Novartis

    collaborator INDUSTRY

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Jorge E Cortes, MD · M.D. Anderson Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-04-30
Primary Completion
2007-04-30
Completion
2015-08-31

Countries

  • United States

Study Locations

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Entities

Companies

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 NCT00050531 on ClinicalTrials.gov