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

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Genentech
ClinicalTrials.gov Identifier:
NCT00452127
First received: March 23, 2007
Last updated: January 18, 2013
Last verified: January 2013
  Purpose

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 Intervention Phase
Non-Hodgkin's Lymphoma
Drug: PRO131921
Phase 1
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Genentech:

Primary Outcome Measures:
  • Dose-limiting toxicities and adverse events [ Time Frame: Length of study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pharmacokinetic parameters; CD19-positive B-cell counts [ Time Frame: Length of study ] [ Designated as safety issue: No ]
  • Overall response; and progression-free survival (Ph. 2 only) [ Time Frame: Length of study ] [ Designated as safety issue: No ]

Enrollment: 26
Study Start Date: May 2007
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: PRO131921
Escalating doses by IV infusion

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00452127

Sponsors and Collaborators
Genentech
Investigators
Study Director: Bill Ho, M.D. Genentech
  More Information

No publications provided

Responsible Party: Genentech
ClinicalTrials.gov Identifier: NCT00452127     History of Changes
Other Study ID Numbers: ACO3967g
Study First Received: March 23, 2007
Last Updated: January 18, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Genentech:
NHL
Indolent
Follicular

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases

ClinicalTrials.gov processed this record on April 14, 2014