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Phase II Study of Hyper-CVAD plus Imatinib Mesylate for Philadelphia-Positive Acute Lymphocytic Leukemia Clinical Trials Data presented on Clinical Trials Search isn't meant to be a substitute for qualified health advice, calls or treatment using a genuine doctor. We are not docs. Always consult your dr. on Phase II Study of Hyper-CVAD plus Imatinib Mesylate for Philadelphia-Positive Acute Lymphocytic Leukemia conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. Phase II Study of Hyper-CVAD plus Imatinib Mesylate for Philadelphia-Positive Acute Lymphocytic Leukemia Clinical research trials and Phase II Study of Hyper-CVAD plus Imatinib Mesylate for Philadelphia-Positive Acute Lymphocytic Leukemia healthcare trials occur in a lot of of places throughout the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the potency of new drugs. The intent of the studies / undertakings is to figure out certain human medical questions. Clinical trials are a popular means for mDs, government agencies, and private sector corporations to locate remedies for all kinds of circumstances, including Phase II Study of Hyper-CVAD plus Imatinib Mesylate for Philadelphia-Positive Acute Lymphocytic Leukemia. Phase II Study of Hyper-CVAD plus Imatinib Mesylate for Philadelphia-Positive Acute Lymphocytic Leukemia Clinical Trials and other clinical trials allow volunteers to obtain health treatment alternatives before they are available to the masses. Many times the participants undergo treatment for free, and sometimes they are paid for their time. Occasionally there is a cost for a Phase II Study of Hyper-CVAD plus Imatinib Mesylate for Philadelphia-Positive Acute Lymphocytic Leukemia clinical trial. Participants typically obtain the most effective healthcare available for their Phase II Study of Hyper-CVAD plus Imatinib Mesylate for Philadelphia-Positive Acute Lymphocytic Leukemia condition. Dangers are a reality, nonetheless, and can include extra or frequent mD trips, medical hazards (potentially life-endangering), and/or the treatment being uneffective. Trials are federally regulated with rigid guidelines to protect clinical trials patients.
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Home > "P" Clinical Trials Conditions > Phase II Study of Hyper-CVAD plus Imatinib Mesylate for Philadelphia-Positive Acute Lymphocytic Leukemia  Phase II Study of Hyper-CVAD plus Imatinib Mesylate for Philadelphia-Positive Acute Lymphocytic Leukemia
Phase II Study of Hyper-CVAD plus Imatinib Mesylate for Philadelphia-Positive Acute Lymphocytic Leukemia
For Condition: Leukemia, Lymphocytic, Acute, L2
Status: Recruiting
Sponsor(s): M.D. Anderson Cancer Center ,
Synopsis: The goal of this clinical research study if to learn if intensive chemotherapy, combined with imatinib mesylate (Gleevec) given for 8 courses over 6 months, followed by maintenance imatinib mesylate plus chemotherapy for 1 year can improve Philadelphia-positive acute lymphoblastic leukemia. The safety of this treatment will also be studied.
Details: Long-term disease-free survival continues to be poor for the Philadelphia-positive ALL group with 2-year rates less than 10%. Imatinib mesylate is a oral tyrosine kinase inhibitor targeting the bcr-abl fusion gene protein, and has demonstrated anti-leukemia activity as a single agent in CML and Philadelphia-positive ALL. Therefore,the combination of imatinib mesylate with the active hyper-CVAD program will be studied. The objective of the clinical trial is to determine the clinical efficacy (overall response rate, even-free survival, and survival) and safety of the intensive short-term chemotherapy regimen (hyper-CVAD program) given in combination with imatinib mesylate for Philadelphia-positive ALL.
Eligibility:
Study Type: Interventional, Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 15 Years/
Genders: Both
Protocol Entry Criteria: Inclusion: - Diagnosis of one of the following: (1) Previously untreated Ph-positive ALL [either t(9;22) or bcr-abl positive] (includes patients initiated on first course of hyper-CVAD before cytogenetics known), or (2) Previously treated Ph-ALL (a) Failure to one course of chemotherapy (b) In CR after 1-2 courses of chemotherapy without imatinib mesylate (Gleevec); (i) If they achieved CR, they are assessable only for event-free and overall survival, or (ii) If they failed to achieve CR, they are assessable for CR, event-free, and overall survival. These groups will be analyzed separately. - Age >/= 15 years; Those < 15 years of age will be treated under compassionate IND; - Zubrod performance status
Total Enrollment: 40
Location and Contact Information:
MD Anderson Cancer Center *Recruiting*
Houston, Texas, 77030
United States
Recruiting Deborah Thomas 713-745-4616
Additional Information:
Study ID Numbers: ID01-006;
Study Start Date: March 2001
Record last reviewed: January 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00038610
Other Leukemia, Lymphocytic, Acute, L2 Studies:
1. Phase II Study of Hyper-CVAD plus Imatinib Mesylate for Philadelphia-Positive Acute Lymphocytic Leukemia
Related Studies:
Other Leukemia, Lymphocytic, Acute, L2 Clinical Trials
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Phase II Study of Hyper-CVAD plus Imatinib Mesylate for Philadelphia-Positive Acute Lymphocytic Leukemia
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