Lymphoma, Follicular
Conditions
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.
Interventions
Obatoclax mesylate 40mg, and 60mg
DRUGRituximab
Rituximab
Sponsors
Gemin X
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response rate | 12 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Time to Tumor Progression. | 20 weeks |
Countries
United States
Outcome results
None listed