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| Sponsors and Collaborators: |
M.D. Anderson Cancer Center 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: imatinib mesylate (Gleevec) Drug: Peg-alpha interferon (Peg-Intron) Drug: sargramostin (GM-CSF) |
| MedlinePlus related topics: | Cancer Leukemia, Adult Acute Leukemia, Adult Chronic |
| ChemIDplus related topics: | Imatinib Imatinib mesylate Sargramostim Granulocyte-macrophage colony-stimulating factor Interferon alfa-2b Interferons Peginterferon Alfa-2b |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Historical Control, Crossover Assignment, Safety/Efficacy Study |
| 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 Sargramostin (GM-CSF) |
| Estimated Enrollment: | 98 |
| Study Start Date: | April 2003 |
| Estimated Study Completion Date: | August 2005 |
Objectives:
Eligibility
| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
The definitions of CML phases are as follows:
Accelerated phase CML: presence of any of the following features:
Contacts and Locations| United States, Texas | |||||
| M.D. Anderson Cancer Center | |||||
| Houston, Texas, United States, 77030 | |||||
| M.D. Anderson Cancer Center |
| Novartis |
| Principal Investigator: | Jorge E Cortes, MD | M.D. Anderson Cancer Center |
More Information
M.D. Anderson Cancer Center's website 
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| Study ID Numbers: | ID02-534 |
| First Received: | December 12, 2002 |
| Last Updated: | September 19, 2007 |
| ClinicalTrials.gov Identifier: | NCT00050531 |
| Health Authority: | United States: Food and Drug Administration |
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