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Treatment of Non-Hodgkin's Lymphoma With 90Y-hLL2 IgG

Primary Purpose

Non-Hodgkin's Lymphoma, Lymphoma, B-Cell

Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
radiolabeled epratuzumab
Sponsored by
Gilead Sciences
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-Hodgkin's Lymphoma focused on measuring NHL, recurrent B-cell lymphoma

Eligibility Criteria

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

Inclusion: Histological or cytological diagnosis of B-cell lymphoma, and has failed at least one regimen of standard chemotherapy. (All histological grades of NHL will be eligible for this trial.) Measureable via CT, with at least one lesion > or = 1.5cm in one or both dimensions. (Splenic tumors in absence of other tumors will not qualify.) Radiological studies (ie - CT) must be performed within 4 weeks prior to study start. Acceptable tumor burden that will allow adequate follow-up and evaluation. Less that 25% bone marrow involvement, determined by bone marrow biopsy. Must observe the following washout periods: At least 4 weeks beyond any major surgery. At least 4 weeks beyond any radiation therapy to the index lesion, and has recovered from radiation-induced toxicity. At least 4 weeks beyond chemotherapy and/or immunotherapy. At least 2 weeks beyond corticosteriod(s) use and blood counts are with laboratory criteria. Must have Karnofsky score >70% (or equivalent, ECOG 0-2) with expected survival of at least 6 months. Serum creatinine < or = 1.5mg/dl or creatinine clearance > or = 50ml/min. Serum bilirubin < or = 2mg/dl. Hemoglobin > or = 10 g/dl; WBC > or = 3000/mm3; granulocyte count > or = 150/mm3; platelet count > or = 100,000/mm3 with out transfusions or cytokines for at least 30 days prior to study. Immunomedics ELISA assay of HahLL2 < 100ng/ml for those with prior history of monoclonal antibody infusions. Cognizant informed consent.

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    May 27, 2003
    Last Updated
    August 12, 2021
    Sponsor
    Gilead Sciences
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00061425
    Brief Title
    Treatment of Non-Hodgkin's Lymphoma With 90Y-hLL2 IgG
    Official Title
    Phase I/II Radioimmunotherapy of Non-Hodgkin's Lymphoma With Radiolabeled Humanized Immuno-LL2: Treatment With 90Y-hLL2 IgG
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2009
    Overall Recruitment Status
    Completed
    Study Start Date
    August 2000 (undefined)
    Primary Completion Date
    November 2007 (Actual)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Gilead Sciences

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The purpose of this trial is to determine the safety of a 90Y-radiolabeled, humanized (CDR-grafted) form of the LL2 monoclonal antibody in patients with Non-Hodgkin's lymphoma (NHL) at different dose levels.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Non-Hodgkin's Lymphoma, Lymphoma, B-Cell
    Keywords
    NHL, recurrent B-cell lymphoma

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1, Phase 2
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    radiolabeled epratuzumab

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion: Histological or cytological diagnosis of B-cell lymphoma, and has failed at least one regimen of standard chemotherapy. (All histological grades of NHL will be eligible for this trial.) Measureable via CT, with at least one lesion > or = 1.5cm in one or both dimensions. (Splenic tumors in absence of other tumors will not qualify.) Radiological studies (ie - CT) must be performed within 4 weeks prior to study start. Acceptable tumor burden that will allow adequate follow-up and evaluation. Less that 25% bone marrow involvement, determined by bone marrow biopsy. Must observe the following washout periods: At least 4 weeks beyond any major surgery. At least 4 weeks beyond any radiation therapy to the index lesion, and has recovered from radiation-induced toxicity. At least 4 weeks beyond chemotherapy and/or immunotherapy. At least 2 weeks beyond corticosteriod(s) use and blood counts are with laboratory criteria. Must have Karnofsky score >70% (or equivalent, ECOG 0-2) with expected survival of at least 6 months. Serum creatinine < or = 1.5mg/dl or creatinine clearance > or = 50ml/min. Serum bilirubin < or = 2mg/dl. Hemoglobin > or = 10 g/dl; WBC > or = 3000/mm3; granulocyte count > or = 150/mm3; platelet count > or = 100,000/mm3 with out transfusions or cytokines for at least 30 days prior to study. Immunomedics ELISA assay of HahLL2 < 100ng/ml for those with prior history of monoclonal antibody infusions. Cognizant informed consent.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    William Wegener
    Organizational Affiliation
    Gilead Sciences
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

    Treatment of Non-Hodgkin's Lymphoma With 90Y-hLL2 IgG

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