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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)

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ClinicalTrials.gov Identifier: NCT00427856
Recruitment Status : Completed
First Posted : January 29, 2007
Last Update Posted : July 22, 2016
Sponsor:
Information provided by (Responsible Party):
Teva Pharmaceutical Industries ( 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.

Condition or disease Intervention/treatment Phase
Lymphoma, Follicular Drug: Obatoclax mesylate Drug: Rituximab Phase 2

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 7 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (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)
Study Start Date : March 2007
Actual Primary Completion Date : February 2009
Actual Study Completion Date : July 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma
Drug Information available for: Rituximab
U.S. FDA Resources

Arm Intervention/treatment
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
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
Rituximab



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

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


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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00427856


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

Responsible Party: Gemin X
ClinicalTrials.gov Identifier: NCT00427856     History of Changes
Other Study ID Numbers: GEM014
First Posted: January 29, 2007    Key Record Dates
Last Update Posted: July 22, 2016
Last Verified: July 2016

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Follicular
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Rituximab
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents