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.
Information provided by:
Genentech, Inc.
ClinicalTrials.gov Identifier:
First received: August 14, 2007
Last updated: June 18, 2010
Last verified: June 2010
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, Inc.:

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


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00517049

Sponsors and Collaborators
Genentech, Inc.
Study Director: Gordon Bray, M.D. Genentech, Inc.
  More Information

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, Inc.:

Additional relevant MeSH terms:
Lymphoma, Non-Hodgkin
Immune System Diseases
Immunoproliferative Disorders
Lymphatic Diseases
Lymphoproliferative Disorders
Neoplasms by Histologic Type
Antineoplastic Agents
Antirheumatic Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 30, 2016