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

Gemin X

Status and phase: Completed; Phase 2

Conditions: Lymphoma, Follicular

Treatments: Drug: Obatoclax mesylate; Drug: Rituximab

Study type: Interventional

Funder types: Industry

Identifiers

NCT00427856

GEM014

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 7 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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7 participants in 2 patient groups

Obatoclax mesylate 40mg

Experimental group

Description:

40 mg over 3 hrs q/weekly for 12 weeks, 4 weeks combo with rituximab, another 8 weeks single-agent obatoclax

Treatment:

Drug: Rituximab

Drug: Obatoclax mesylate

Obatoclax mesylate 60mg

Experimental group

Description:

60 mg obatoclax mesylate over 24 hours, q/weekly for 12 weeks, 4 weeks combo with rituximab, another 8 weeks single-agent obatoclax

Treatment:

Drug: Rituximab

Drug: Obatoclax mesylate