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)
18 Years
N/A
Both
Lymphoma, Follicular
Trial Information
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)
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.
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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Determine the response rate to obatoclax in combination with rituximab and characterize the safety profile.
Safety Issue:
Yes
Principal Investigator
Jean Viallet, MD
Investigator Role:
Study Director
Investigator Affiliation:
Gemin X, Inc.
Authority:
United States: Food and Drug Administration
Study ID:
GEM014
NCT ID:
NCT00427856
Start Date:
March 2007
Completion Date:
July 2009
Related Keywords:
- Lymphoma, Follicular
- Lymphoma
- Lymphoma, Follicular
Name | Location |
|---|---|
| The Cancer Center at Hackensack University Medical Center | Hackensack, New Jersey 07601 |
