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

Sponsor:	M.D. Anderson Cancer Center
Collaborator:	Novartis
Information provided by:	M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT00050531

Purpose

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.

Condition	Intervention
Leukemia, Myeloid, Chronic	Drug: Gleevec Drug: Peg-alpha interferon (Peg-Intron) Drug: Sargramostim (GM-CSF)

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Randomized Trial of Therapy of Early Phase Chronic Myelogenous Leukemia With High-Dose Imatinib Mesylate (Gleevec) Alone or in Combination With Peg-Alpha Interferon (PEG-Intron) and Sargramostim (GM-CSF)

Resource links provided by NLM:

MedlinePlus related topics: Cancer Chronic Myeloid Leukemia Leukemia

Drug Information available for: Interferon alfa-2a Granulocyte-macrophage colony-stimulating factor Interferon alfa-2b Sargramostim Imatinib Peginterferon Alfa-2b Imatinib mesylate Interferon alfa-n1 Interferons

U.S. FDA Resources

Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:

Durations of PCR negativity, cytogenetic response, hematologic control, and survival. [ Time Frame: November 2012 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Response Rates [ Time Frame: November 2012 ] [ Designated as safety issue: No ]

Estimated Enrollment:	98
Study Start Date:	April 2003
Estimated Study Completion Date:	November 2012
Estimated Primary Completion Date:	November 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Gleevec	Drug: Gleevec 400 mg orally twice daily. Other Names: Imatinib Mesylate STI-571 Drug: Peg-alpha interferon (Peg-Intron) PEG-IFN 0.5 mcg/kg each week subcutaneously. Other Names: PEG Interferon Interferon Alfa-2b (PEG conjugate)
Experimental: Gleevec + Peg-Intron + GM-CSF	Drug: Gleevec 400 mg orally twice daily. Other Names: Imatinib Mesylate STI-571 Drug: Peg-alpha interferon (Peg-Intron) PEG-IFN 0.5 mcg/kg each week subcutaneously. Other Names: PEG Interferon Interferon Alfa-2b (PEG conjugate) Drug: Sargramostim (GM-CSF) 125 mcg/m^2 three times per week subcutaneously. Other Names: LeukineTM Granulocyte-Macrophage Colony Stimulating Factor

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Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients with Ph-positive CML in early chronic phase CML who have received no or minimal prior therapy, (<1 month of prior IFN-alpha (with or without ara-C) and/or Gleevec).
ECOG performance of 0-2.
Adequate end organ function, defined as the following: total bilirubin < 1.5 x ULN, SGPT < 2.5 x ULN, creatinine < 1.5 x ULN
Signed informed consent.

Exclusion Criteria:

NYHA cardiac class 3-4 heart disease.
Psychiatric disability (psychosis)
Pregnant or lactating females
Late chronic phase, accelerated or blastic phase

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00050531

Locations

United States, Texas
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030

Sponsors and Collaborators

M.D. Anderson Cancer Center

Novartis

Investigators

Principal Investigator:

Jorge E Cortes, MD

M.D. Anderson Cancer Center

More Information

Additional Information:

M.D. Anderson Cancer Center's website This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Jorge Cortes M.D./Professor, The University of Texas M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT00050531 History of Changes
Other Study ID Numbers:	ID02-534
Study First Received:	December 12, 2002
Last Updated:	May 6, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by M.D. Anderson Cancer Center:

Chronic Myelogenous Leukemia
CML
Early Chronic Phase Chronic Myelogenous Leukemia
Imatinib Mesylate
Gleevec

Peg-Alpha Interferon
Peg-Intron
Sargramostim
GM-CSF

Additional relevant MeSH terms:

Leukemia
Leukemia, Myeloid
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Neoplasms by Histologic Type
Neoplasms
Myeloproliferative Disorders
Bone Marrow Diseases
Hematologic Diseases
Interferon-alpha
Interferon Alfa-2b
Interferons
Peginterferon alfa-2b
Imatinib
Antiviral Agents

Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on February 09, 2012