A Study of PRO95780 in Combination With Rituximab in Patients With Non-Hodgkin's Lymphoma That Has Progressed Following Previous Rituximab Therapy (APM4083g)

Study Overview
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Brief Summary
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This Phase II, single-arm, open-label, multicenter trial is designed to evaluate the safety, efficacy, and pharmacokinetics of PRO95780 when combined with rituximab in patients with follicular, CD20-positive B-cell NHL that has progressed following previous rituximab therapy.

Official Title
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A Phase II, Single-Arm, Open-Label Study of the Safety, Pharmacokinetics, and Efficacy of Multiple Doses of PRO95780 Administered Intravenously in Combination With Rituximab in Patients With Follicular, CD20-Positive B-Cell Non-Hodgkin's Lymphoma That Has Progressed Following Previous Rituximab Therapy

Conditions
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Non-Hodgkin's Lymphoma

Intervention / Treatment
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* Drug: PRO95780
* Drug: rituximab


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Signed Informed Consent Form Age ≥ 18 years Diagnosis of follicular, CD20-positive B-cell NHL Progression of disease after an objective response or stable disease lasting > 6 months following completion of the most recent rituximab-containing regimen Measurable disease Life expectancy of > 3 months Exclusion Criteria: Grade 3b follicular lymphoma (according to the WHO classification) or histologic transformation from follicular lymphoma to aggressive lymphoma Prior radiotherapy to a lesion(s) that will be used to assess response unless that lesion(s) shows clear evidence of lymphoma progression at baseline Radiotherapy to a peripheral lesion within 14 days prior to Cycle 1, Day 1 or radiotherapy to a thoracic, abdominal, or pelvic field within 28 days prior to Cycle 1, Day 1 Concurrent systemic corticosteroid therapy Other invasive malignancies within 3 years prior to first study drug administration except for adequately treated basal or squamous cell skin cancer, in situ carcinoma of the cervix, in situ breast cancer, in situ prostate cancer, limited-stage bladder cancer, or other cancers from which the patient has been disease-free for at least 3 years. History or evidence on physical examination of central nervous system (CNS) disease Prior treatment with agonistic DR4 or DR5 antibodies or Apo2L/TRAIL

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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: PRO95780<br>* Intravenous repeating dose<br>Drug: rituximab<br>* Intravenous repeating dose<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective response, as determined by independent review facility |  | 8 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free survival, as determined by independent review facility |  | up to 12 months | 
| Duration of objective response, as determined by independent review facility |  | up to 10.3 months | 
| Overall survival |  | Up to 18.5 months | 
| Objective response, as determined by the investigator |  | Up to 8 months | 
| Progression-free survival, as determined by the investigator |  | Up to 18.5 months | 
| Duration of objective response, as determined by the investigator |  | Up to 14.1 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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NHL, Rituxan, Lymphoma, CD20-positive, B-Cell, APM4083g