NCT00517049CompletedPhase 2
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
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Genentech, Inc.
- Enrollment
- 49
- Primary Endpoint
- Objective response, as determined by independent review facility
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
1
Experimental
Intervention: PRO95780 (Drug)
1
Experimental
Intervention: rituximab (Drug)
Outcomes
Primary Outcomes
Objective response, as determined by independent review facility
Time Frame: 8 months
Secondary Outcomes
- Duration of objective response, as determined by independent review facility(up to 10.3 months)
- Duration of objective response, as determined by the investigator(Up to 14.1 months)
- Overall survival(Up to 18.5 months)
- Progression-free survival, as determined by independent review facility(up to 12 months)
- Progression-free survival, as determined by the investigator(Up to 18.5 months)
- Objective response, as determined by the investigator(Up to 8 months)
Investigators
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