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

Phase 1

Terminated

• Conditions: Non-Hodgkin's Lymphoma
• Interventions: Drug: PRO131921

• Registration Number: NCT00452127
• Lead Sponsor: Genentech, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2007-03-23
• Study First Submitted QC: 2007-03-23
• Study First Posted: 2007-03-27
• Study Start: 2007-05
• Primary Completion: 2009-05
• Status Verified: 2013-01
• Disposition First Submitted: 2013-01-18
• Disposition First Submitted QC: 2013-01-18
• Last Update Submitted: 2013-01-18
• Disposition First Posted: 2013-01-28
• Last Update Posted: 2013-01-28

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 26

Inclusion Criteria

Not provided

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	PRO131921	-

Primary Outcome Measures

Name	Time	Method
Dose-limiting toxicities and adverse events	Length of study

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetic parameters; CD19-positive B-cell counts	Length of study
Overall response; and progression-free survival (Ph. 2 only)	Length of study