A PHASE II STUDY OF G3139 (GENASENSE™, NSC # 683428 IND # 58842) + IMATINIB MESYLATE (GLEEVEC®, STI571) IN PATIENTS WITH IMATINIB-RESISTANT CHRONIC MYELOID LEUKEMIA
I. To estimate the cytogenetic response rate of patients with CML who have had less than a
complete hematologic response or less than major cytogenetic response to imatinib mesylate
and who have been treated after two cycles of imatinib mesylate + G3139.
I. To estimate the hematologic, cytogenetic and molecular response rate and duration in
patients diagnosed with CML who have been treated after two and four cycles of imatinib
mesylate + G3139.
II. To estimate the toxicity of these two drugs given in combination in a cooperative group
Patients receive oblimersen IV continuously on days 1-10 and oral imatinib mesylate once or
twice daily. Treatment repeats every 21 days for up to 4 courses in the absence of disease
progression or unacceptable toxicity. Patients without a hematologic response after 2
courses go off study. Patients with complete or partial response after 4 courses may
continue to receive oral imatinib mesylate daily.
Patients in cohort 2 receive an escalated dose of oblimersen; if well tolerated, subsequent
cohorts receive oblimersen at the higher dose with the original dose of imatinib mesylate.
If oblimersen is not well tolerated in cohort 2, subsequent cohorts receive the original
dose of oblimersen with an escalated dose of imatinib mesylate. The first 6 patients accrued
continue to receive the original dose (dose taken prior to study) of imatinib mesylate
throughout the study.
Patients are followed monthly for 3 months and then every 3 months for 5 years.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Cytogenetic response rate in bone marrow
Cancer and Leukemia Group B
United States: Food and Drug Administration
|Cancer and Leukemia Group B||Chicago, Illinois 60606|