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

NCT ID: NCT00427856

Last Updated: 2016-07-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 7 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-03-31
• Study Completion Date: 2009-07-31

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.

Conditions

Lymphoma, Follicular

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Obatoclax mesylate 40mg

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

Group Type: EXPERIMENTAL

Obatoclax mesylate

Intervention Type: DRUG

Obatoclax mesylate 40mg, and 60mg

Rituximab

Intervention Type: DRUG

Rituximab

Obatoclax mesylate 60mg

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

Group Type: EXPERIMENTAL

Obatoclax mesylate

Intervention Type: DRUG

Obatoclax mesylate 40mg, and 60mg

Rituximab

Intervention Type: DRUG

Rituximab

Interventions

Obatoclax mesylate

Obatoclax mesylate 40mg, and 60mg

Intervention Type: DRUG

Rituximab

Rituximab

Intervention Type: DRUG

Other Intervention Names

(GX15-070MS)

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Gemin X

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jean Viallet, MD

Role: STUDY_DIRECTOR

Gemin X, Inc.

Locations

The Cancer Center at Hackensack University Medical Center

Hackensack, New Jersey, United States

Countries

United States

Other Identifiers

GEM014

Identifier Type: -

Identifier Source: org_study_id