A Phase I/II Study of Obatoclax Mesylate (GX15-070MS) Administered in Combination With Bortezomib to Patients With Relapsed or Refractory Mantle Cell Lymphoma (MCL)
18 Years
N/A
Both
Mantle-Cell Lymphoma
Trial Information
A Phase I/II Study of Obatoclax Mesylate (GX15-070MS) Administered in Combination With Bortezomib to Patients With Relapsed or Refractory Mantle Cell Lymphoma (MCL)
This is a multi-center, open-label, Phase I study of Obatoclax administered in combination
with bortezomib in 3-week cycles to patients with relapsed or refractory Mantle Cell
Lymphoma. Treatment may be administered on an outpatient basis. No investigational or
commercial agents or therapies other than those described herein may be administered with
the intent to treat the patients's malignancy. Supportive care measures including those
directed at controlling symptoms resulting from Mantle Cell Lymphoma are allowed.
Inclusion Criteria:
- Pathological confirmation of Mantle Cell Lymphoma (ML)
- Must have documented relapse or progression following 1 or 2 prior lines of
antineoplastic therapy
- Must have normal 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
- Patients with prior exposure to obatoclax
- 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: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Determine the response rate to obatoclax in combination with Bortezomib and characterize the safety profile
Outcome Time Frame:
4 weeks to 2 years
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:
GEM012
NCT ID:
NCT00407303
Start Date:
October 2006
Completion Date:
November 2009
Related Keywords:
- Mantle-Cell Lymphoma
- Lymphoma
- Lymphoma, Mantle-Cell
Name | Location |
|---|---|
| Hackensack University Medical Center | Hackensack, New Jersey 07601 |
| Northwestern University Feinberg School of Medicine | Chicago, Illinois 60611 |
| University of Wisconsin | Madison,, Wisconsin 53792-5666 |
| NW Georgia Oncology Centers | Marietta, Georgia 30060 |
| Roswell Park Medical Center | Buffalo, New York 14263 |
