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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
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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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