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Phase II trial of decitabine in patients with chronic myelogenous leukemia accelerated phase who are refractory to imatinib mesylate (Gleevec) Clinical Trials Facts presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, travels to or professional assistance by using a genuine doctor. We aren't mDs. Always consult your physician about Phase II trial of decitabine in patients with chronic myelogenous leukemia accelerated phase who are refractory to imatinib mesylate (Gleevec) conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Phase II trial of decitabine in patients with chronic myelogenous leukemia accelerated phase who are refractory to imatinib mesylate (Gleevec) Clinical research trials and Phase II trial of decitabine in patients with chronic myelogenous leukemia accelerated phase who are refractory to imatinib mesylate (Gleevec) health trials occur in a lot of of cities throughout the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the potency of new does drugs. The role of the studies / undertakings is to figure out specific human healthcare questions. Clinical trials are a popular manner for mDs, government agencies, and private sector companies to locate treatments for all sorts of conditions, including Phase II trial of decitabine in patients with chronic myelogenous leukemia accelerated phase who are refractory to imatinib mesylate (Gleevec). Phase II trial of decitabine in patients with chronic myelogenous leukemia accelerated phase who are refractory to imatinib mesylate (Gleevec) Clinical Trials and other clinical trials permit volunteers to get medical treatment choices before they are available to the general public. Many times the test subjects get professional assistance for free of charge, and occasionally they are compensated for their time. Sometimes there is a cost for a Phase II trial of decitabine in patients with chronic myelogenous leukemia accelerated phase who are refractory to imatinib mesylate (Gleevec) clinical trial. Human subjects often get the best healthcare possible for their Phase II trial of decitabine in patients with chronic myelogenous leukemia accelerated phase who are refractory to imatinib mesylate (Gleevec) condition. Risks are a reality, nevertheless, and could include additional or frequent dr. calls, medical hazards (perhaps life-threatening), and/or the treatment being ineffectual. Trials are federally governed with exacting guidelines to protect clinical trials patients.
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Home > "P" Clinical Trials Conditions > Phase II trial of decitabine in patients with chronic myelogenous leukemia accelerated phase who are refractory to imatinib mesylate (Gleevec) Phase II trial of decitabine in patients with chronic myelogenous leukemia accelerated phase who are refractory to imatinib mesylate (Gleevec)
Phase II trial of decitabine in patients with chronic myelogenous leukemia accelerated phase who are refractory to imatinib mesylate (Gleevec)
For Condition: Chronic Myelogenous Leukemia
Status: Recruiting
Sponsor(s): SuperGen ,
Synopsis: To determine the safety and efficacy of decitabine in patients with Philadelphia chromosome-positive chronic myelogenous leukemia accelerated phase that were previously treated with imatinib mesylate (STI 571) and became resistant/refractory or were found to be intolerant to the drug.
Details:
Eligibility:
Study Type: Interventional, Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 2 Years/
Genders: Both
Protocol Entry Criteria: Inclusion: - Histologically confirmed diagnosis of CML accelerated phase - Ph chromosome-positive - Previous treatment with imatinib mesylate resulting in: i) Hematologic Resistance / Hematologic Refractory: Based on a physician’s (documented) decision to discontinue imatinib mesylate treatment due to failure of continued benefit or no benefit to the patient, ii) Imatinib Mesylate Intolerance: any toxicity resulting in a physician’s (documented) decision to discontinue imatinib mesylate treatment. - Patients must have recovered from the side effects of previous CML therapy for accelerated phase with the exception of hydroxyurea - Age >/= 2 years - Bilirubin = 3 x the upper limit of normal (ULN), SGOT and SGPT = 3 x ULN, except = 5 x ULN in leukemic involvement of the liver, serum creatinine = 2 x ULN - WHO performance status 0-3 - A negative serum hCG pregnancy test in patients of childbearing potential - Able to give signed informed consent directly or through a parent or guardian for minors Exclusion: - Leukemic involvement of the central nervous system - Active malignancy other than CML or non-melanoma cancer of the skin - Previous treatment for CML with another investigational agent within 28 days of study entry - At study entry, patients who were treated with: imatinib mesylate within the past 48 hours; interferon-alpha within the past 48 hours; homoharringtonine within the past 14 days; low-dose cytosine arabinoside within 7 days, moderate dose within 14 days, or high dose within 28 days; etoposide, anthracyclines, or mitoxantrone within 21 days; busulfan within the past six weeks - Patients who had received hematopoietic stem cell transplantation within 6 weeks of Day 1 decitabine therapy - Patients with Grade 3/4 cardiac disease or any other serious concurrent medical condition. - Patients who are pregnant or nursing. All patients of childbearing potential must practice effective methods of contraception while on study. - Patients with mental illness or other condition precluding their ability to give informed consent or to comply with study requirements - Patients with systemic, uncontrolled infections
Total Enrollment: 40
Location and Contact Information:
University of Texas MD Anderson Cancer Center *Recruiting*
Houston, Texas, 77030
United States
Recruiting Jean-Pierre Issa
Additional Information:
Study ID Numbers: SGI-DAC-013; DAC-013
Study Start Date: July 2002
Record last reviewed: July 2002
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00041990
Other Chronic Myelogenous Leukemia Studies:
1. Combination Chemotherapy and Thalidomide in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia, Chronic Myelogenous Leukemia, or Advanced Myelodysplastic Syndromes
2. Dose-Determining Study of R115777 for Childhood Leukemia
3. CD8 DLI for Patients With Relapse or Residual Disease Following Allogeneic Stem Cell Transplantation
4. Bone Marrow Transplantation in Treating Patients With Multiple Myeloma, Chronic Phase Chronic Myelogenous Leukemia, or Agnogenic Myeloid Metaplasia
5. Chemotherapy Plus Sargramostim in Treating Patients With Refractory Myeloid Cancer
Related Studies:
Other Chronic Myelogenous Leukemia Clinical Trials
Other Texas Clinical Trials
Other Houston Clinical Trials
Phase II trial of decitabine in patients with chronic myelogenous leukemia accelerated phase who are refractory to imatinib mesylate (Gleevec)
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