Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsors and Collaborators: |
M.D. Anderson Cancer Center Novartis Pharmaceuticals |
---|---|
Information provided by: | M.D. Anderson Cancer Center |
ClinicalTrials.gov Identifier: | NCT00038675 |
The goal of this clinical research study is to see if Gleevec, known as imatinib mesylate (STI571), can improve the disease condition in patients with hypereosinophilic syndrome, polycythemia vera, atypical CML or CMML with PDGF-R fusion genes, or mastocytosis.
Optional Procedures: Patients will be asked to have some extra blood and/or bone marrow samples taken. These samples will be used to evaluate the effect of the treatment on leukemic cells.
Condition | Intervention |
---|---|
Chronic Myelomonocytic Leukemia Chronic Myeloid Leukemia Polycythemia Vera Hypereosinophilic Syndrome Mastocytosis |
Drug: Imatinib Mesylate (Gleevec) |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Therapy of Hypereosinophilic Syndrome, Polycythemia Vera, Atypical CML or CMML With PDGF-R Fusion Genes, or Mastocytosis With Imatinib Mesylate (STI571) |
Estimated Enrollment: | 145 |
Study Start Date: | June 2001 |
Estimated Study Completion Date: | June 2011 |
Estimated Primary Completion Date: | June 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental
Imatinib
|
Drug: Imatinib Mesylate (Gleevec)
Imatinib mesylate 400 mg orally daily. In HES start with imatinib mesylate 100mg orally daily
|
Imatinib mesylate is a chemical compound that blocks a protein that is responsible for a certain form of leukemia. However, imatinib mesylate also blocks other important proteins that may be responsible for other blood diseases such as myeloproliferative disorders.
Before treatment starts, patients will have a physical exam, including medical history and documentation of disease, blood tests, and a bone marrow study. The bone marrow will be removed with a large needle. Women able to have children will have a screening blood or urine test for pregnancy.
Patients in this study will take 4 tablets of imatinib mesylate by mouth every day. Patients with HES will take 1 tablet daily to begin, and may go up to 4 tablets daily depending on response. Imatinib mesylate should be taken each morning at breakfast with a large glass of water. Bottles containing the tablets will be given to the patient every month. Unused supplies must be returned at the end of the study. Patients taking oral hydroxyurea to control their blood counts, can continue it during the first month of imatinib mesylate treatment, but must stop taking it from then on.
After completing 2 months of therapy, response to imatinib mesylate will be evaluated. If the response is good, treatment with imatinib mesylate alone will be continued. If the response is not good, the dose of imatinib mesylate will be increased to 8 tablets daily (4 in the morning and 4 in the evening) or may be decreased to 3 tablets daily. This will be based on how the drug is tolerated. Treatment may be continued for up to one year, or as long as it is judged best to control the leukemia.
Patients will be asked to visit their doctor for a physical exam and vital signs. The frequency of doctor visits will vary depending on physical condition. Continued monitoring of blood tests will be required every week during the first month then every 2 to 4 weeks from then on.
Blood tests (about 2 teaspoons) will be done every 2-6 weeks for the first 6 months on study, then every 3-4 months. The blood samples will be used for routine lab tests. A bone marrow sample will also be taken to check and measure cells related to the disease after 3 - 4 months, then every 3-6 months in the first year. If the initial bone marrow sample does not show disease, repeated bone marrows will not be done.
This is an investigational study. Imatinib mesylate has been approved in CML for patients whose disease has not responded to interferon. However, this is an investigational study in patients with myeloproliferative diseases.
The FDA has authorized the use of imatinib mesylate in research. A total of 145 patients will take part in this study. All will be enrolled at M. D. Anderson.
Optional Procedures: Patients who agree will have about 2 teaspoons of blood and/or bone marrow taken before therapy and every 3 months during therapy. To collect a bone marrow biopsy, an area of the hip or chest bone is numbed with anesthetic and a small amount of bone marrow is withdrawn through a needle.
You do not have to agree to take part in the optional procedures in order to receive treatment on this study.
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria: None
United States, Texas | |
U.T.M.D. Anderson Cancer Center | |
Houston, Texas, United States, 77030 |
Principal Investigator: | Jorge Cortes, MD | U.T.M.D. Anderson Cancer Center |
Responsible Party: | The University of Texas M. D. Anderson Cancer Center ( Jorge Cortes, M.D./ Professor ) |
Study ID Numbers: | ID01-167 |
Study First Received: | June 4, 2002 |
Last Updated: | April 21, 2009 |
ClinicalTrials.gov Identifier: | NCT00038675 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Leukemia Chronic Myelomonocytic Leukemia Chronic Myeloid Leukemia Polycythemia Vera |
Hypereosinophilic Syndrome Mastocytosis Imatinib Mesylate Gleevec |
Polycythemia Chronic Myelomonocytic Leukemia Mast Cell Disease Leukocyte Disorders Protein Kinase Inhibitors Leukemia Neoplasms, Connective and Soft Tissue Hypereosinophilic Syndrome Idiopathic Hypereosinophilic Syndrome Myelodysplastic Myeloproliferative Disease Polycythemia Vera Skin Diseases Hematologic Diseases |
Leukemia, Myelomonocytic, Chronic Myeloproliferative Disorders Leukemia, Myeloid Eosinophilia Leukemia, Myelomonocytic, Acute Imatinib Leukemia, Myelogenous, Chronic, BCR-ABL Positive Mastocytoma Mastocytosis Chronic Myelogenous Leukemia Bone Marrow Diseases Myelodysplastic-Myeloproliferative Diseases |
Polycythemia Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Leukocyte Disorders Protein Kinase Inhibitors Leukemia Neoplasms, Connective and Soft Tissue Pathologic Processes Therapeutic Uses Hypereosinophilic Syndrome Syndrome Polycythemia Vera Neoplasms by Histologic Type Disease Skin Diseases |
Hematologic Diseases Leukemia, Myelomonocytic, Chronic Myeloproliferative Disorders Enzyme Inhibitors Leukemia, Myeloid Eosinophilia Pharmacologic Actions Leukemia, Myelomonocytic, Acute Imatinib Neoplasms Leukemia, Myelogenous, Chronic, BCR-ABL Positive Mastocytoma Mastocytosis Neoplasms, Connective Tissue Bone Marrow Diseases |