A Study of PRO95780 in Combination With Rituximab in Patients With Non-Hodgkin's Lymphoma That Has Progressed Following Previous Rituximab Therapy (APM4083g)

Non-Hodgkin's Lymphoma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00517049
• Other study ID #: APM4083g
• Status: Completed
• Phase: Phase 2
• First received: August 14, 2007
• Last updated: May 31, 2017
• Start date: March 2008
• Est. completion date: December 2009

Study information

• Verified date: May 2017
• Source: Genentech, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, Non-Hodgkin
• Non-Hodgkin's Lymphoma

Intervention

Drug:
• PRO95780
Intravenous repeating dose
• rituximab
Intravenous repeating dose

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Genentech, Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective response, as determined by independent review facility		8 months
Secondary	Progression-free survival, as determined by independent review facility		up to 12 months
Secondary	Duration of objective response, as determined by independent review facility		up to 10.3 months
Secondary	Overall survival		Up to 18.5 months
Secondary	Objective response, as determined by the investigator		Up to 8 months
Secondary	Progression-free survival, as determined by the investigator		Up to 18.5 months
Secondary	Duration of objective response, as determined by the investigator		Up to 14.1 months