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Randomized Trial of High-Dose Gleevec Alone or in Combination with Peg-Alpha Interferon and GM-CSF in Early Phase CML 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 Randomized Trial of High-Dose Gleevec Alone or in Combination with Peg-Alpha Interferon and GM-CSF in Early Phase CML conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. Randomized Trial of High-Dose Gleevec Alone or in Combination with Peg-Alpha Interferon and GM-CSF in Early Phase CML Clinical research trials and Randomized Trial of High-Dose Gleevec Alone or in Combination with Peg-Alpha Interferon and GM-CSF in Early Phase CML 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 Randomized Trial of High-Dose Gleevec Alone or in Combination with Peg-Alpha Interferon and GM-CSF in Early Phase CML. Randomized Trial of High-Dose Gleevec Alone or in Combination with Peg-Alpha Interferon and GM-CSF in Early Phase CML 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 Randomized Trial of High-Dose Gleevec Alone or in Combination with Peg-Alpha Interferon and GM-CSF in Early Phase CML clinical trial. Human subjects often get the best healthcare available for their Randomized Trial of High-Dose Gleevec Alone or in Combination with Peg-Alpha Interferon and GM-CSF in Early Phase CML 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 > "R" Clinical Trials Conditions > Randomized Trial of High-Dose Gleevec Alone or in Combination with Peg-Alpha Interferon and GM-CSF in Early Phase CML  Randomized Trial of High-Dose Gleevec Alone or in Combination with Peg-Alpha Interferon and GM-CSF in Early Phase CML
Randomized Trial of High-Dose Gleevec Alone or in Combination with Peg-Alpha Interferon and GM-CSF in Early Phase CML
For Condition: Leukemia, Myeloid, Chronic
Status: Recruiting
Sponsor(s): M.D. Anderson Cancer Center ,
Synopsis: 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.
Details: Objectives: 1. To determine whether the combination of High-dose Imatinib Mesylate (Gleevec, formerly known as STI571), PEG-Interferon alpha (PEG-IFN) and GM-CSF can increase the percentage of patients who achieve low levels of PCR ratios of Bcr-Abl/Bcr (molecular CR) after 12 months of therapy. 2. To increase the proportion of patients achieving a complete cytogenetic response in patients with Ph-positive early chronic phase CML using the combination of Imatinib Mesylate (Gleevec, STI571), PEG-Interferon alpha (PEG-IFN) and GM-CSF. 3. Secondary end-points: · To evaluate the durations of PCR negativity, cytogenetic response, hematologic control, and survival. · To analyze differences in response rates and in prognosis within different risk groups and patient characteristics.
Eligibility:
Study Type: Interventional, Treatment, Randomized, Open Label, Historical Control, Crossover Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: INCLUSION: - Patients with a diagnosis of Ph-positive or Bcr-positive CML in early chronic phase CML (i.e., time from diagnosis 12 months). Except for hydroxyurea, patients must have received no or minimal prior therapy, defined as <1 month of prior IFN-a (with or without ara-C) and/or Gleevec. - Age => 18 years - ECOG performance of 0-2. - Adequate end organ function, defined as the following: total bilirubin <1.5x ULN, SGPT <2.5x ULN, creatinine <1.5x ULN. - 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. EXCLUSION: - NYHA cardiac class 3-4 heart disease - Patients with active, uncontrolled psychiatric disorders including: psychosis, major depression, and bipolar disorders. - Female patients of childbearing potential must have negative pregnancy test within 7 days before initiation of study drug dosing. Postmenopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential. Male and female patients of reproductive potential must agree to employ an effective method of birth control throughout the study and for up to 3 months following discontinuation of study drug. - Patients in late chronic phase (i.e., time from diagnosis to treatment >12 months), accelerated phase or blastic phase are excluded. The definitions of CML phases are as follows: a. Early chronic phase: time from diagnosis to therapy < 12 months Late chronic phase: time from diagnosis to therapy > 12 months b. Blastic phase: presence of 30% blasts or more in the peripheral blood or bone marrow. c. Accelerated phase CML: presence of any of the following features: * Peripheral or marrow blasts 15% or more * Peripheral or marrow basophils 20% or more * Thrombocytopenia < 100 x 109/L unrelated to therapy * Documented extramedullary blastic disease outside liver or spleen due to past causes - Clonal evolution defined as the presence of additional chromosomal abnormalities other than the Ph chromosome is part of accelerated phase CML. Ph chromosome variants or complex Ph chromosome translocations are not considered to indicate disease acceleration. We have recently found clonal evolution to have a variable prognostic impact and may be suppressed with IFN-a therapy. Hence these patients will be eligible if no other signs of accelerated phase are present, and analyzed separately.
Total Enrollment: 98
Location and Contact Information:
Overall Study Official:
JorgeCortes, Principal Investigator, M.D. Anderson Cancer Center
M.D. Anderson Cancer Center *Recruiting*
Houston, Texas, 77030
United States
Recruiting Jorge Cortes 713-794-5783
Additional Information:
Study ID Numbers: ID02-534;
Study Start Date: April 2003
Record last reviewed: May 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00050531
Other Leukemia, Myeloid, Chronic Studies:
1. Safety and Tolerability Study of FPTI in Patients With Leukemia
2. A exploratory, open-label study of the investigational product, AG-858, in patients who are cytogenetically positive after treatment with Gleevecâ„¢.
3. Randomized Trial of High-Dose Gleevec Alone or in Combination with Peg-Alpha Interferon and GM-CSF in Early Phase CML
4. Phase I Study of Zarnestra and Gleevec in Chronic Phase Chronic Myelogenous Leukemia
5. Randomized double cord blood transplant study
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Randomized Trial of High-Dose Gleevec Alone or in Combination with Peg-Alpha Interferon and GM-CSF in Early Phase CML
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