A Multi-Center, Open-Label, Phase II Study of Sequential, Single-Agent Obatoclax Mesylate (GX15-070MS)Followed by a Combination With Rituximab to Patients With Previously-Untreated Follicular Lymphoma (FL)
This is a multi-center, open-label, Phase II study of obatoclax administered alone as a
weekly, 3-hour or 24-hour infusion for 12 weeks followed by a combination with rituximab to
patients with previously-untreated Follicular Lymphoma. For purposes of clinical
evaluations, treatment cycles will occur in 4-week periods. Treatment may be administered on
an outpatient basis. No investigational or commercial agents or therapies other than those
described may be administered with the intent to treat the patient's malignancy.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Determine the response rate to obatoclax in combination with rituximab and characterize the safety profile.
Jean Viallet, MD
Gemin X, Inc.
United States: Food and Drug Administration
|The Cancer Center at Hackensack University Medical Center||Hackensack, New Jersey 07601|