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Therapy of Hypereosinophilic Syndrome, Polycythemia Vera, Atypical CML or CMML with PDGF-R Fusion Genes, or Mastocytosis with Gleevec Clinical Trials Info presented on Clinical Trials Search is not intended to be a substitute for certified medical advice, visits or professional assistance using a real physician. We are not physicians. Always consult your dr. about Therapy of Hypereosinophilic Syndrome, Polycythemia Vera, Atypical CML or CMML with PDGF-R Fusion Genes, or Mastocytosis with Gleevec conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. Therapy of Hypereosinophilic Syndrome, Polycythemia Vera, Atypical CML or CMML with PDGF-R Fusion Genes, or Mastocytosis with Gleevec Clinical research trials and Therapy of Hypereosinophilic Syndrome, Polycythemia Vera, Atypical CML or CMML with PDGF-R Fusion Genes, or Mastocytosis with Gleevec health trials happen in many of localities throughout the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically measure the effectualness of new drugs. The function of the studies / projects is to resolve particular human medical questions. Clinical trials are a popular manner for mDs, government agencies, and private sector corporations to discover remedies for all varieties of circumstances, like Therapy of Hypereosinophilic Syndrome, Polycythemia Vera, Atypical CML or CMML with PDGF-R Fusion Genes, or Mastocytosis with Gleevec. Therapy of Hypereosinophilic Syndrome, Polycythemia Vera, Atypical CML or CMML with PDGF-R Fusion Genes, or Mastocytosis with Gleevec Clinical Trials and other clinical trials allow volunteers to obtain healthcare treatment options before they are available to the masses. Some times the participants undergo professional assistance for free of charge, and occasionally they are paid for their time. Sometimes there is a cost for a Therapy of Hypereosinophilic Syndrome, Polycythemia Vera, Atypical CML or CMML with PDGF-R Fusion Genes, or Mastocytosis with Gleevec clinical trial. Human subjects often get the best healthcare available for their Therapy of Hypereosinophilic Syndrome, Polycythemia Vera, Atypical CML or CMML with PDGF-R Fusion Genes, or Mastocytosis with Gleevec condition. Dangers are a reality, however, and may include additional or frequent mD visits, healthcare dangers (potentially life-jeopardising), and/or the treatment being ineffectual. Trials are federally governed with rigorous guidelines to protect clinical trials patients.
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Home > "T" Clinical Trials Conditions > Therapy of Hypereosinophilic Syndrome, Polycythemia Vera, Atypical CML or CMML with PDGF-R Fusion Genes, or Mastocytosis with Gleevec  Therapy of Hypereosinophilic Syndrome, Polycythemia Vera, Atypical CML or CMML with PDGF-R Fusion Genes, or Mastocytosis with Gleevec
Therapy of Hypereosinophilic Syndrome, Polycythemia Vera, Atypical CML or CMML with PDGF-R Fusion Genes, or Mastocytosis with Gleevec
For Condition: Chronic Myeloid Leukemia,Polycythemia Vera,Hypereosinophilic Syndrome,Mastocytosis,Chronic Myelomonocytic Leukemia
Status: Recruiting
Sponsor(s): M.D. Anderson Cancer Center ,
Synopsis: 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.
Details: To date, 25 patients with myeloproliferative syndromes have been included in this study. Five of 9 patients with HES have responded. The efficacy of Gleevec in HES has been confirmed in at least one other study. We have also treated 5 patients with PV and two of them have experienced a reduction in the need for transfusions and at least two others have reported symptomatic improvement. A beneficial effect from Gleevec has been observed also by other investigators. Responses in mastocytosis have been reported recently in 4 of 9 patients treated. In addition, patients with atypical CML or CMML with PDGF-R fusion genes have been reported to have significant activity with imatinib. We have not identified any clinical activity in other disease categories originally included on this study. Thus, we plan to continue accrual only in the following groups:  HES  Atypical CML or CMML with PDGF-R fusion genes  PV  Mastocytosis
Eligibility:
Study Type: Interventional, Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: Patients must meet the following eligibility criteria: - Patients must have one of the following hematopoietic malignancies: a. Hypereosinophilic syndrome (HES) b. Polycythemia vera (PV) c. Atypical CML or CMML with PDGF-R fusion genes d. Mastocytosis - Serum bilirubin less than 2mg%, serum creatinine less than 2mg% unless abnormality is considered due to hematologic malignancy by investigator. - ECOG Performance Status < 3. Life expectancy > 12 weeks. - Patients must sign an informed consent indicating they are aware of the investigational nature of this study, in keeping with the policies of the hospital. - Women of pregnancy potential must practice birth control. Women and men must continue birth control for the duration of the trial and at least 3 months after the last dose of study drug. - Inclusion of women and minorities: As per NIH policy, women and members of minorities will be included in this protocol as they are referred in the relevant populations. There are no exclusions of women or minorities based on the study objectives. - NYHA Class < 3.
Total Enrollment: 100
Location and Contact Information:
M.D. Anderson Cancer Center *Recruiting*
Houston, Texas, 77030
United States
Recruiting Jorge Cortes 713-794-5783
Additional Information:
Study ID Numbers: ID01-167;
Study Start Date: June 2001
Record last reviewed: March 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00038675
Other Chronic Myeloid Leukemia Studies:
1. Idarubicin, Cytarabine, and Gemtuzumab Ozogamicin in Treating Patients With Previously Untreated High-Risk Myelodysplastic Syndrome or Acute Myeloid Leukemia Secondary to Myelodysplastic Syndrome
2. Chemotherapy in Treating Patients With Newly Diagnosed Acute or Chronic Myelogenous Leukemia or Myelodysplastic Syndrome
3. Decitabine in Treating Patients With Myelodysplastic Syndrome
4. PTK787/ZK 222584 in Treating Patients With Primary or Secondary Myelodysplastic Syndromes
5. Decitabine Compared With Supportive Care in Treating Patients With Advanced Myelodysplastic Syndromes
Related Studies:
Other Chronic Myeloid Leukemia Clinical Trials
Other Texas Clinical Trials
Other Houston Clinical Trials
Therapy of Hypereosinophilic Syndrome, Polycythemia Vera, Atypical CML or CMML with PDGF-R Fusion Genes, or Mastocytosis with Gleevec
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