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
Inclusion Criteria
- Signed informed consent
- Ability and willingness to comply with the requirements of the study protocol
- Age ≥ 18 years
- 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
- 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
- Bi-dimensionally measurable disease, with at least one lesion >1.5 cm in its largest
dimension
- Absolute B‑cell count ≥LLN at screening (Phase I only)
- ECOG performance status of 0, 1, or 2
- 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
- For females of childbearing potential, a negative serum pregnancy test within 14 days
prior to enrollment
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