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

NCT00517049 | Completed Phase 2

• 1 other identifier: APM4083g
• Study Type: interventional
• Target: 49
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Non-Hodgkin's Lymphoma

Keywords

NHL; Rituxan; Lymphoma; CD20-positive; B-Cell; APM4083g

Outcome Measures

Primary Outcomes (1)

• Objective response, as determined by independent review facility

  8 months

Secondary Outcomes (6)

• Progression-free survival, as determined by independent review facility

  up to 12 months

• Duration of objective response, as determined by independent review facility

  up to 10.3 months

• Overall survival

  Up to 18.5 months

• Objective response, as determined by the investigator

  Up to 8 months

• Progression-free survival, as determined by the investigator

  Up to 18.5 months

Study Arms (1)

1

EXPERIMENTAL

Drug: PRO95780; Drug: rituximab

Interventions

PRO95780 DRUG

Intravenous repeating dose

1

rituximab DRUG

Intravenous repeating dose

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Genentech, Inc.: lead

MeSH Terms

Conditions

Lymphoma, Non-Hodgkin; Lymphoma

Interventions

drozitumab; Rituximab

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Gordon Bray, M.D.

  Genentech, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 14, 2007
• First Posted: August 16, 2007
• Study Start: March 1, 2008
• Primary Completion: December 1, 2009
• Study Completion: December 1, 2009
• Last Updated: June 6, 2017

Record last verified: 2017-05