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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:
ClinicalTrials.gov Identifier:
NCT00517049
First Posted: August 16, 2007
Last Update Posted: June 6, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Genentech, Inc.
  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: None (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 ]

Secondary Outcome Measures:
  • Progression-free survival, as determined by independent review facility [ Time Frame: up to 12 months ]
  • Duration of objective response, as determined by independent review facility [ Time Frame: up to 10.3 months ]
  • Overall survival [ Time Frame: Up to 18.5 months ]
  • Objective response, as determined by the investigator [ Time Frame: Up to 8 months ]
  • Progression-free survival, as determined by the investigator [ Time Frame: Up to 18.5 months ]
  • Duration of objective response, as determined by the investigator [ Time Frame: Up to 14.1 months ]

Enrollment: 49
Actual 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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00517049


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

Responsible Party: Genentech, Inc.
ClinicalTrials.gov Identifier: NCT00517049     History of Changes
Other Study ID Numbers: APM4083g
First Submitted: August 14, 2007
First Posted: August 16, 2007
Last Update Posted: June 6, 2017
Last Verified: May 2017

Keywords provided by Genentech, Inc.:
NHL
Rituxan
Lymphoma
CD20-positive
B-Cell
APM4083g

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