A Trial of the Safety of Escalating Doses of PRO131921 in Patients With Relapsed or Refractory Indolent Non-Hodgkin's Lymphoma

NCT ID: NCT00452127

Last Updated: 2013-01-28

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 26 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-05-31

Brief Summary

This is an open-label, multicenter, Phase I/II study of the safety of escalating doses of single-agent PRO131921 in patients with relapsed or refractory CD20-positive indolent NHL. The trial will enroll in two phases: a Phase I dose-escalation portion for patients with indolent NHL and a Phase II portion with enrollment of additional patients with follicular NHL into two expanded treatment cohorts in order to expand the safety database and collect preliminary anti-lymphoma activity data.

Conditions

Non-Hodgkin's Lymphoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

Group Type: EXPERIMENTAL

PRO131921

Intervention Type: DRUG

Escalating doses by IV infusion

Interventions

PRO131921

Escalating doses by IV infusion

Intervention Type: DRUG

Eligibility Criteria

Exclusion Criteria

• Prior use of anti-CD20 monoclonal antibody therapy (other than rituximab or radioimmunotherapy)
• Prior use of any non-CD20-targeted monoclonal antibody therapy within 6 months of enrollment
• Current or recent lymphoma treatment
• History of severe allergic or anaphylactic reactions to human, humanized, chimeric, or murine monoclonal antibodies
• Evidence of significant uncontrolled concomitant diseases, such as cardiovascular disease, nervous system, pulmonary, renal, hepatic, endocrine, or gastrointestinal disorders
• Evidence of myelodysplasia or myelodysplastic changes on bone marrow examination
• Untreated or persistent/recurrent malignancy (other than lymphoma)
• Known active bacterial, viral, fungal, mycobacterial, or other infection
• A major episode of infection requiring hospitalization or treatment with IV antimicrobials within 4 weeks of screening or oral antimicrobials within 2 weeks of screening
• History of recurrent significant infection or bacterial infections
• Positive hepatitis B or C serology
• Positive human immunodeficiency virus (HIV) serology
• Pregnancy or lactation
• Central nervous system lymphoma
• Recent major surgery within 4 weeks of screening, other than diagnostic surgery

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Genentech, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bill Ho, M.D.

Role: STUDY_DIRECTOR

Genentech, Inc.

Other Identifiers

ACO3967g

Identifier Type: -

Identifier Source: org_study_id