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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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)

Conditions
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Lymphoma, Follicular

Intervention / Treatment
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* Drug: Obatoclax mesylate
* Drug: Rituximab


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Obatoclax mesylate 40mg<br>40 mg over 3 hrs q/weekly for 12 weeks, 4 weeks combo with rituximab, another 8 weeks single-agent obatoclax | Drug: Obatoclax mesylate<br>* Obatoclax mesylate 40mg, and 60mg<br>* Other names: (GX15-070MS);Drug: Rituximab<br>* Rituximab<br>|
| Experimental: Obatoclax mesylate 60mg<br>60 mg obatoclax mesylate over 24 hours, q/weekly for 12 weeks, 4 weeks combo with rituximab, another 8 weeks single-agent obatoclax | Drug: Obatoclax mesylate<br>* Obatoclax mesylate 40mg, and 60mg<br>* Other names: (GX15-070MS);Drug: Rituximab<br>* Rituximab<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response rate |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to Tumor Progression. |  | 20 weeks |