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

Phase 2

Completed

• Conditions: Lymphoma, Follicular
• Interventions: Drug: Obatoclax mesylate; Drug: Rituximab

• Registration Number: NCT00427856
• Lead Sponsor: Gemin X

Brief Summary

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2007-01-25
• Study First Submitted QC: 2007-01-26
• Study First Posted: 2007-01-29
• Study Start: 2007-03
• Primary Completion: 2009-02
• Study Completion: 2009-07
• Disposition First Submitted: 2013-08-16
• Disposition First Submitted QC: 2013-08-16
• Disposition First Posted: 2013-08-26
• Status Verified: 2016-07
• Last Update Submitted: 2016-07-20
• Last Update Posted: 2016-07-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 7

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Obatoclax mesylate 40mg	Obatoclax mesylate	40 mg over 3 hrs q/weekly for 12 weeks, 4 weeks combo with rituximab, another 8 weeks single-agent obatoclax
Obatoclax mesylate 60mg	Obatoclax mesylate	60 mg obatoclax mesylate over 24 hours, q/weekly for 12 weeks, 4 weeks combo with rituximab, another 8 weeks single-agent obatoclax
Obatoclax mesylate 60mg	Rituximab	60 mg obatoclax mesylate over 24 hours, q/weekly for 12 weeks, 4 weeks combo with rituximab, another 8 weeks single-agent obatoclax
Obatoclax mesylate 40mg	Rituximab	40 mg over 3 hrs q/weekly for 12 weeks, 4 weeks combo with rituximab, another 8 weeks single-agent obatoclax

Primary Outcome Measures

Name	Time	Method
Response rate	12 weeks

Secondary Outcome Measures

Name	Time	Method
Time to Tumor Progression.	20 weeks

Trial Locations

Locations (1)

The Cancer Center at Hackensack University Medical Center; 🇺🇸 Hackensack, New Jersey, United States