Overview

Safety and Efficacy of Single Agent Obatoclax Mesylate (GX15-070MS) Followed by a Combination With Rituximab for Previously-untreated Follicular Lymphoma (FL)

Status:
Completed
Trial end date:
2009-07-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Gemin X
Treatments:
Obatoclax
Rituximab
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