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

Primary Purpose

Non-Hodgkin's Lymphoma

Status
Terminated
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
PRO131921
Sponsored by
Genentech, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-Hodgkin's Lymphoma focused on measuring NHL, Indolent, Follicular

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers
  • 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    1

    Arm Description

    Outcomes

    Primary Outcome Measures

    Dose-limiting toxicities and adverse events

    Secondary Outcome Measures

    Pharmacokinetic parameters; CD19-positive B-cell counts
    Overall response; and progression-free survival (Ph. 2 only)

    Full Information

    First Posted
    March 23, 2007
    Last Updated
    January 18, 2013
    Sponsor
    Genentech, Inc.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00452127
    Brief Title
    A Trial of the Safety of Escalating Doses of PRO131921 in Patients With Relapsed or Refractory Indolent Non-Hodgkin's Lymphoma
    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 Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2013
    Overall Recruitment Status
    Terminated
    Study Start Date
    May 2007 (undefined)
    Primary Completion Date
    May 2009 (Actual)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Genentech, Inc.

    4. Oversight

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Non-Hodgkin's Lymphoma
    Keywords
    NHL, Indolent, Follicular

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1, Phase 2
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    26 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    1
    Arm Type
    Experimental
    Intervention Type
    Drug
    Intervention Name(s)
    PRO131921
    Intervention Description
    Escalating doses by IV infusion
    Primary Outcome Measure Information:
    Title
    Dose-limiting toxicities and adverse events
    Time Frame
    Length of study
    Secondary Outcome Measure Information:
    Title
    Pharmacokinetic parameters; CD19-positive B-cell counts
    Time Frame
    Length of study
    Title
    Overall response; and progression-free survival (Ph. 2 only)
    Time Frame
    Length of study

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Bill Ho, M.D.
    Organizational Affiliation
    Genentech, Inc.
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

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

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