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

Genentech

Status and phase

Terminated

Phase 2

Phase 1

Conditions

Non-Hodgkin's Lymphoma

Treatments

Drug: PRO131921

Study type

Interventional

Funder types

Industry

Identifiers

NCT00452127

ACO3967g

Details and patient eligibility

About

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.

Enrollment

26 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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