A Trial of the Safety of Escalating Doses of PRO131921 in Patients With Relapsed or Refractory Indolent Non-Hodgkin's Lymphoma
An Open-Label, Multicenter, Phase I/II Trial of the Safety of Escalating Doses of PRO131921 in Patients With Relapsed or Refractory Indolent Non-Hodgkin's Lymphoma Who Have Been Treated With a Prior Rituximab-Containing Regimen
1 other identifier
interventional
26
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 23, 2007
CompletedFirst Posted
Study publicly available on registry
March 27, 2007
CompletedStudy Start
First participant enrolled
May 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2009
CompletedJanuary 28, 2013
January 1, 2013
2 years
March 23, 2007
January 18, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Dose-limiting toxicities and adverse events
Length of study
Secondary Outcomes (2)
Pharmacokinetic parameters; CD19-positive B-cell counts
Length of study
Overall response; and progression-free survival (Ph. 2 only)
Length of study
Study Arms (1)
1
EXPERIMENTALInterventions
Eligibility Criteria
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Genentech, Inc.lead
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bill Ho, M.D.
Genentech, Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 23, 2007
First Posted
March 27, 2007
Study Start
May 1, 2007
Primary Completion
May 1, 2009
Last Updated
January 28, 2013
Record last verified: 2013-01