|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | June 4, 2002 | ||||
| Last Updated Date | April 21, 2009 | ||||
| Start Date ICMJE | June 2001 | ||||
| Estimated Primary Completion Date | June 2010 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
To determine the objective response rate in patients with Hypereosinophilic syndrome (HES), polycythemia vera (PV), atypical CML or CMML with PDGF-R fusion genes, and mastocytosis. [ Time Frame: June 2010 ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE |
To determine the objective response rate in patients with Hypereosinophilic syndrome (HES), polycythemia vera (PV), atypical CML or CMML with PDGF-R fusion genes, and mastocytosis. [ Time Frame: June 2009 ] [ Designated as safety issue: No ] | ||||
| Change History | Complete list of historical versions of study NCT00038675 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
To evaluate duration of response and survival. To investigate evidence of clonality in patients with PV and correlation with any possible response to imatinib in this subgroup of patients. [ Time Frame: June 2011 ] [ Designated as safety issue: No ] | ||||
| Original Secondary Outcome Measures ICMJE |
To evaluate duration of response and survival. To investigate evidence of clonality in patients with PV and correlation with any possible response to imatinib in this subgroup of patients. [ Time Frame: June 2009 ] [ Designated as safety issue: No ] | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Therapy of HES, PV, Atypical CML or CMML, and Mastocytosis With Imatinib Mesylate | ||||
| Official Title ICMJE | Therapy of Hypereosinophilic Syndrome, Polycythemia Vera, Atypical CML or CMML With PDGF-R Fusion Genes, or Mastocytosis With Imatinib Mesylate (STI571) | ||||
| Brief Summary | 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. |
||||
| Detailed Description | 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. |
||||
| Study Phase | |||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study | ||||
| Condition ICMJE |
|
||||
| Intervention ICMJE | Drug: Imatinib Mesylate (Gleevec) | ||||
| Study Arms / Comparison Groups | Experimental: Imatinib | ||||
| Publications * | |||||
|
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
|||||
| Recruitment Information | |||||
| Recruitment Status ICMJE | Active, not recruiting | ||||
| Estimated Enrollment ICMJE | 145 | ||||
| Estimated Completion Date | June 2011 | ||||
| Estimated Primary Completion Date | June 2010 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria: None |
||||
| Gender | Both | ||||
| Ages | |||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00038675 | ||||
| Responsible Party | Jorge Cortes, M.D./ Professor, The University of Texas M. D. Anderson Cancer Center | ||||
| Study ID Numbers ICMJE | ID01-167 | ||||
| Study Sponsor ICMJE | M.D. Anderson Cancer Center | ||||
| Collaborators ICMJE | Novartis Pharmaceuticals | ||||
| Investigators ICMJE |
|
||||
| Information Provided By | M.D. Anderson Cancer Center | ||||
| Verification Date | April 2009 | ||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||