Status:
COMPLETED
Safety and Efficacy of Single Agent Obatoclax Mesylate (GX15-070MS) Followed by a Combination With Rituximab for Previously-untreated Follicular Lymphoma (FL)
Lead Sponsor:
Gemin X
Conditions:
Lymphoma, Follicular
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 ...
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 previo...
Eligibility Criteria
Inclusion
- 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
- No other agents or therapies administered with the intent to treat malignancy
- Uncontrolled, intercurrent illness
- Pregnant women and women who are breast feeding
Key Trial Info
Start Date :
March 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2009
Estimated Enrollment :
7 Patients enrolled
Trial Details
Trial ID
NCT00427856
Start Date
March 1 2007
End Date
July 1 2009
Last Update
July 22 2016
Active Locations (1)
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1
The Cancer Center at Hackensack University Medical Center
Hackensack, New Jersey, United States, 07601