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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00452127
Recruitment Status : Terminated
First Posted : March 27, 2007
Last Update Posted : January 28, 2013
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Non-Hodgkin's Lymphoma Drug: PRO131921 Phase 1 Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 26 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : May 2007
Actual Primary Completion Date : May 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Arm Intervention/treatment
Experimental: 1 Drug: PRO131921
Escalating doses by IV infusion

Primary Outcome Measures :
  1. Dose-limiting toxicities and adverse events [ Time Frame: Length of study ]

Secondary Outcome Measures :
  1. Pharmacokinetic parameters; CD19-positive B-cell counts [ Time Frame: Length of study ]
  2. Overall response; and progression-free survival (Ph. 2 only) [ Time Frame: Length of study ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00452127

Sponsors and Collaborators
Genentech, Inc.
Study Director: Bill Ho, M.D. Genentech, Inc.

Responsible Party: Genentech, Inc. Identifier: NCT00452127     History of Changes
Other Study ID Numbers: ACO3967g
First Posted: March 27, 2007    Key Record Dates
Last Update Posted: January 28, 2013
Last Verified: January 2013

Keywords provided by Genentech, Inc.:

Additional relevant MeSH terms:
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs