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:
Information provided by:
Genentech
ClinicalTrials.gov Identifier:
NCT00517049
First received: August 14, 2007
Last updated: June 18, 2010
Last verified: June 2010
  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
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
Investigators
Study Director: Gordon Bray, M.D. Genentech
  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, Non-Hodgkin
Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Rituximab
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents

ClinicalTrials.gov processed this record on September 18, 2014