Back to resultsSafety and Efficacy of Single Agent Obatoclax Mesylate (GX15-070MS) Followed by a Combination With Rituximab for Previously-untreated Follicular Lymphoma (FL)
Primary Purpose
Lymphoma, Follicular
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Obatoclax mesylate
Rituximab
Sponsored by
About this trial
This is an interventional treatment trial for Lymphoma, Follicular
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
Sites / Locations
- The Cancer Center at Hackensack University Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Obatoclax mesylate 40mg
Obatoclax mesylate 60mg
Arm Description
40 mg over 3 hrs q/weekly for 12 weeks, 4 weeks combo with rituximab, another 8 weeks single-agent obatoclax
60 mg obatoclax mesylate over 24 hours, q/weekly for 12 weeks, 4 weeks combo with rituximab, another 8 weeks single-agent obatoclax
Outcomes
Primary Outcome Measures
Response rate
Secondary Outcome Measures
Time to Tumor Progression.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00427856
Brief Title
Safety and Efficacy of Single Agent Obatoclax Mesylate (GX15-070MS) Followed by a Combination With Rituximab for Previously-untreated Follicular Lymphoma (FL)
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 Type
Interventional
2. Study Status
Record Verification Date
July 2016
Overall Recruitment Status
Completed
Study Start Date
March 2007 (undefined)
Primary Completion Date
February 2009 (Actual)
Study Completion Date
July 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Gemin X
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphoma, Follicular
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
7 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Obatoclax mesylate 40mg
Arm Type
Experimental
Arm Description
40 mg over 3 hrs q/weekly for 12 weeks, 4 weeks combo with rituximab, another 8 weeks single-agent obatoclax
Arm Title
Obatoclax mesylate 60mg
Arm Type
Experimental
Arm Description
60 mg obatoclax mesylate over 24 hours, q/weekly for 12 weeks, 4 weeks combo with rituximab, another 8 weeks single-agent obatoclax
Intervention Type
Drug
Intervention Name(s)
Obatoclax mesylate
Other Intervention Name(s)
(GX15-070MS)
Intervention Description
Obatoclax mesylate 40mg, and 60mg
Intervention Type
Drug
Intervention Name(s)
Rituximab
Intervention Description
Rituximab
Primary Outcome Measure Information:
Title
Response rate
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Time to Tumor Progression.
Time Frame
20 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean Viallet, MD
Organizational Affiliation
Gemin X, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
The Cancer Center at Hackensack University Medical Center
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
12. IPD Sharing Statement
Learn more about this trial
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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