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Sponsors and Collaborators: |
M.D. Anderson Cancer Center Novartis |
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Information provided by: | M.D. Anderson Cancer Center |
ClinicalTrials.gov Identifier: | NCT00050531 |
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 |
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Leukemia, Myeloid, Chronic |
Drug: Gleevec Drug: Peg-alpha interferon (Peg-Intron) Drug: sargramostim (GM-CSF) |
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 Sargramostim (GM-CSF) |
Enrollment: | 94 |
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 |
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1: Experimental
Gleevec
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Drug: Gleevec
Gleevec 400 mg orally twice daily.
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2: Experimental
Gleevec + Peg-Intron + GM-CSF
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Drug: Gleevec
Gleevec 400 mg orally twice daily.
Drug: Peg-alpha interferon (Peg-Intron)
PEG-IFN 0.5 mcg/kg/week subcutaneously
Drug: sargramostim (GM-CSF)
GM-CSF 125mcg/m^2 TIW subcutaneously
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Imatinib mesylate is a drug that blocks a protein that is responsible for the development of CML. PEG-Intron is a natural substance made by the cells of the immune system and helps to control CML. GM-CSF is a hormone that helps to stimulate the production of white blood cells.
Before treatment starts, you will have a physical exam, blood tests (around 1-2 tablespoons), and a sample of bone marrow collected. To collect a bone marrow sample, an area of the hip or chest bone is numbed with anaesthetic and a small amount of bone marrow is withdrawn through a large needle. Women who are able to have children must have a negative blood or urine pregnancy test.
During the study you will take 4 tablets of imatinib mesylate by mouth 2 times a day (8 tablets a day total). Imatinib mesylate should be taken each morning and evening with a large glass of water. Bottles containing the tablets will be given to you every month. You will also be given a "pill diary" to write down when (day and time) you take the drug. You will also write in the diary any side effects you may experience. You should bring the diary, any unused tablets, and empty bottles of imatinib mesylate with you to every visit to the study doctor. Any unused supplies must be returned at the end of the study.
After completing 6 months of imatinib mesylate therapy, you will be randomly assigned (as in the toss of a coin) to one of two groups. Patients in the first group will be given PEG-Intron and GM-CSF in addition to imatinib mesylate therapy. Patients in the other group will continue taking only imatinib mesylate.
If you are assigned to the group that will receive PEG-Intron and GM-CSF, you will continue taking imatinib mesylate. In addition, PEG-Intron will be given as an injection under the skin once a week. Sargramostim will be given as an injection under the skin 3 times a week. You and/or your family members can be taught to give these injections.
Every 1-2 weeks during the first 4 weeks of the study, you will have around 2 teaspoons of blood drawn for routine blood tests and to measure the amount of imatinib in your blood. The blood tests will then be repeated every 6 to 8 weeks (or more often if your doctor feels it is necessary) for as long as you are on the study. A bone marrow sample will also be taken every 3 months for the first year and then every 4 to 6 months for as long as you are on the study to check on the status of the disease .
You will be asked to visit the doctor for a physical exam and to have vital signs measured. These visits will be scheduled at least every 3 months while you are on the study. The visits may be scheduled more often depending on the status of the disease.
Treatment in both groups may be continued for up to 7-10 years, or as long as the doctor feels is necessary to control the leukemia.
If the disease gets worse or you experience any intolerable side effects, you will be taken off the study and your doctor will discuss other treatment options with you.
This is an investigational study. All of the drugs used in this study are FDA approved and commercially available. However, their use in this study is investigational. A total of 98 patients will take part in this study. All will be enrolled at M. D. Anderson.
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:
Early chronic phase: time from diagnosis to therapy < 12 months
Late chronic phase: time from diagnosis to therapy > 12 months
Accelerated phase CML: presence of any of the following features:
United States, Texas | |
M.D. Anderson Cancer Center | |
Houston, Texas, United States, 77030 |
Principal Investigator: | Jorge E Cortes, MD | M.D. Anderson Cancer Center |
Responsible Party: | The University of Texas M.D. Anderson Cancer Center ( Jorge Cortes M.D./Professor ) |
Study ID Numbers: | ID02-534 |
Study First Received: | December 12, 2002 |
Last Updated: | November 20, 2008 |
ClinicalTrials.gov Identifier: | NCT00050531 |
Health Authority: | United States: Food and Drug Administration |
Chronic Myelogenous Leukemia CML Early Chronic Phase Chronic Myelogenous Leukemia Imatinib Mesylate Gleevec |
Peg-Alpha Interferon Peg-Intron Sargramostim GM-CSF |
Interferon-alpha Interferon Type I, Recombinant Chronic myelogenous leukemia Hematologic Diseases Interferons Myeloproliferative Disorders Leukemia, Myeloid Leukemia, Myeloid, Chronic-Phase |
Imatinib Leukemia Leukemia, Myelogenous, Chronic, BCR-ABL Positive Peginterferon alfa-2b Bone Marrow Diseases Interferon Alfa-2a Interferon Alfa-2b |
Anti-Infective Agents Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Growth Substances Physiological Effects of Drugs Enzyme Inhibitors |
Protein Kinase Inhibitors Antiviral Agents Angiogenesis Inhibitors Pharmacologic Actions Neoplasms Therapeutic Uses Angiogenesis Modulating Agents Growth Inhibitors |