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

This study has been completed.
Information provided by (Responsible Party):
Teva Pharmaceutical Industries ( Gemin X ) Identifier:
First received: January 25, 2007
Last updated: July 20, 2016
Last verified: July 2016
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.

Condition Intervention Phase
Lymphoma, Follicular
Drug: Obatoclax mesylate
Drug: Rituximab
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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)

Resource links provided by NLM:

Further study details as provided by Teva Pharmaceutical Industries ( Gemin X ):

Primary Outcome Measures:
  • Response rate [ Time Frame: 12 weeks ]

Secondary Outcome Measures:
  • Time to Tumor Progression. [ Time Frame: 20 weeks ]

Enrollment: 7
Study Start Date: March 2007
Study Completion Date: July 2009
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Obatoclax mesylate 40mg
40 mg over 3 hrs q/weekly for 12 weeks, 4 weeks combo with rituximab, another 8 weeks single-agent obatoclax
Drug: Obatoclax mesylate
Obatoclax mesylate 40mg, and 60mg
Other Name: (GX15-070MS)
Drug: Rituximab
Experimental: 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
Drug: Obatoclax mesylate
Obatoclax mesylate 40mg, and 60mg
Other Name: (GX15-070MS)
Drug: Rituximab

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.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00427856

United States, New Jersey
The Cancer Center at Hackensack University Medical Center
Hackensack, New Jersey, United States, 07601
Sponsors and Collaborators
Gemin X
Study Director: Jean Viallet, MD Gemin X, Inc.
  More Information

Responsible Party: Gemin X Identifier: NCT00427856     History of Changes
Other Study ID Numbers: GEM014
Study First Received: January 25, 2007
Last Updated: July 20, 2016

Additional relevant MeSH terms:
Lymphoma, Follicular
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents processed this record on May 25, 2017