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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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, Non-Hodgkin
Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases

ClinicalTrials.gov processed this record on September 18, 2014