A Trial of the Safety of Escalating Doses of PRO131921 in Patients With Relapsed or Refractory Indolent Non-Hodgkin's Lymphoma
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 1/Phase 2 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 1
|
Drug: PRO131921
Escalating doses by IV infusion
|
Outcome Measures
Primary Outcome Measures
- Dose-limiting toxicities and adverse events [Length of study]
Secondary Outcome Measures
- Pharmacokinetic parameters; CD19-positive B-cell counts [Length of study]
- Overall response; and progression-free survival (Ph. 2 only) [Length of study]
Eligibility Criteria
Criteria
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Signed informed consent
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Ability and willingness to comply with the requirements of the study protocol
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Age ≥ 18 years
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Documented history of histologically confirmed CD20-positive follicular NHL (Phases I and II); for Phase I, other CD20-positive indolent lymphomas (marginal zone lymphoma and small lymphocytic lymphoma) are also included. Patients with a history of a CD20-positive NHL of mixed (indolent/aggressive) histology may also be included in Phase I if the most recent relapse biopsy shows only indolent NHL
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Indolent lymphoma (Phase I) or follicular lymphoma (Phase II) that either has relapsed after a documented history of response (CR, CRu, or PR) of ≥6 months to a rituximab-containing regimen or was refractory to a previous rituximab-containing regimen
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Bi-dimensionally measurable disease, with at least one lesion >1.5 cm in its largest dimension
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Absolute B-cell count ≥LLN at screening (Phase I only)
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ECOG performance status of 0, 1, or 2
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For patients of reproductive potential (males and females), use of a reliable means of contraception during the study and for 1 year following the last dose of study treatment
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For females of childbearing potential, a negative serum pregnancy test within 14 days prior to enrollment
Exclusion Criteria:
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Prior use of anti-CD20 monoclonal antibody therapy (other than rituximab or radioimmunotherapy)
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Prior use of any non-CD20-targeted monoclonal antibody therapy within 6 months of enrollment
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Current or recent lymphoma treatment
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History of severe allergic or anaphylactic reactions to human, humanized, chimeric, or murine monoclonal antibodies
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Evidence of significant uncontrolled concomitant diseases, such as cardiovascular disease, nervous system, pulmonary, renal, hepatic, endocrine, or gastrointestinal disorders
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Evidence of myelodysplasia or myelodysplastic changes on bone marrow examination
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Untreated or persistent/recurrent malignancy (other than lymphoma)
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Known active bacterial, viral, fungal, mycobacterial, or other infection
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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
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History of recurrent significant infection or bacterial infections
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Positive hepatitis B or C serology
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Positive human immunodeficiency virus (HIV) serology
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Pregnancy or lactation
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Central nervous system lymphoma
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Recent major surgery within 4 weeks of screening, other than diagnostic surgery
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Genentech, Inc.
Investigators
- Study Director: Bill Ho, M.D., Genentech, Inc.
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- ACO3967g