A Study of PRO95780 in Combination With Rituximab in Patients With Non-Hodgkin's Lymphoma That Has Progressed Following Previous Rituximab Therapy (APM4083g)
This study has been completed.
Sponsor:
Genentech
Information provided by:
Genentech
ClinicalTrials.gov Identifier:
NCT00517049
First received: August 14, 2007
Last updated: June 18, 2010
Last verified: June 2010
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Non-Hodgkin's Lymphoma |
Drug: PRO95780 Drug: rituximab |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | 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 |
Resource links provided by NLM:
Further study details as provided by Genentech:
Primary Outcome Measures:
- Objective response, as determined by independent review facility [ Time Frame: 8 months ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Progression-free survival, as determined by independent review facility [ Time Frame: Length of study ] [ Designated as safety issue: No ]
- Duration of objective response, as determined by independent review facility [ Time Frame: Length of study ] [ Designated as safety issue: No ]
- Overall survival [ Time Frame: Until death or loss to follow-up ] [ Designated as safety issue: No ]
- Objective response, PFS, and duration of objective response, as determined by the investigator [ Time Frame: Length of study ] [ Designated as safety issue: No ]
| Enrollment: | 49 |
| Study Start Date: | March 2008 |
| Study Completion Date: | December 2009 |
| Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 |
Drug: PRO95780
Intravenous repeating dose
Drug: rituximab
Intravenous repeating dose
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations More Information
No publications provided
| Responsible Party: | Clinical Trials Posting Group, Genentech, Inc. |
| ClinicalTrials.gov Identifier: | NCT00517049 History of Changes |
| Other Study ID Numbers: | APM4083g |
| Study First Received: | August 14, 2007 |
| Last Updated: | June 18, 2010 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Genentech:
|
NHL Rituxan Lymphoma |
CD20-positive B-Cell APM4083g |
Additional relevant MeSH terms:
|
Lymphoma Lymphoma, Non-Hodgkin Lymphoma, B-Cell Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders |
Immune System Diseases Rituximab Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Antirheumatic Agents Therapeutic Uses Antineoplastic Agents |
ClinicalTrials.gov processed this record on May 16, 2013