Safety and Efficacy of Single Agent Obatoclax Mesylate (GX15-070MS) Followed by a Combination With Rituximab for Previously-untreated Follicular Lymphoma (FL)

Defects in the apoptotic process can lead to the onset of cancer by allowing cells to grow unchecked when an oncogenic signal is present. Obatoclax is designed to restore apoptosis through inhibition of the Bcl-2 family of proteins, thereby reinstating the natural process of cell death that is often inhibited in cancer cells.

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.

• Experimental: 1
  40 mg obatoclax over 3 hrs q/weekly
  Intervention: Drug: Obatoclax mesylate (GX15-070MS)
• Experimental: 2
  60 mg obatoclax over 24 hours, q/weekly
  Intervention: Drug: Obatoclax mesylate (GX15-070MS)

Inclusion Criteria:

• Pathological confirmation of Follicular Lymphoma (FL)
• Must have advanced stage disease
• Must not have received any prior chemotherapy or immunotherapy for lymphoma, including steroids
• Must have adequate organ function
• Must have the ability to understand and willingness to sign a written informed consent form

Exclusion Criteria:

• No other agents or therapies administered with the intent to treat malignancy
• Uncontrolled, intercurrent illness
• Pregnant women and women who are breast feeding