Last updated: 11/04/2018 08:15:20

Study of HuMax-CD20, a New Drug to Treat Early Stage Non-Hodgkin´s Follicular Lymphoma

GSK study ID
Hx-CD20-001
Clinicaltrials.gov ID
NCT00092274
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Other
Other
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: An Open-label, International, Multicenter, Dose Escalating, Phase I/II Study of HuMax-CD20 in Patients with Relapsed or Refractory Follicular Lymphoma Grade I-II
Trial description: The purpose of this trial is to determine the safety and efficacy of HuMax-CD20 as a treatment for Follicular Lymphoma (FL).
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Non-randomized
Primary outcomes:
Not applicable
Secondary outcomes:
Not applicable
Interventions:
  • Drug: HuMax-CD20
    • Enrollment:
    0
    Primary completion date:
    2005-31-01
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Not applicable
    Medical condition
    Lymphoma, Follicular
    Product
    Not applicable
    Collaborators
    Not applicable
    Study date(s)
    September 2004 to November 2005
    Type
    Interventional
    Phase
    1/2

    Participation criteria

    Sex
    Female & Male
    Age
    18+ years
    Accepts healthy volunteers
    No
    • Relapsed or refractory follicular lymphoma grade I-II
    • Tumor verified to be CD20 positive
    • Previous treatment with rituximab resulting in less than partial response
    • Previous radioimmunotherapy
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Relapsed or refractory follicular lymphoma grade I-II
    • Tumor verified to be CD20 positive
    • CT scan showing demarcated lesions
    Exclusion criteria:
    • Previous treatment with rituximab resulting in less than partial response
    • Previous radioimmunotherapy
    • Previous stem cell transplantation
    • Received the following treatments within 4 weeks prior to entering this study: a) Anti-cancer therapy b) Glucocorticosteroids unless less than 10 mg prednisolone/day c) Radiotherapy
    • Received Mitomycin C or Nitrosoureas within 6 weeks prior to entering this trial
    • HIV positivity
    • Hepatitis B or hepatitis C
    • Uncontrolled or chronic bacterial, fungal or viral infection
    • Other cancer diseases, except certain skin cancers, cervix cancer and breast cancer
    • Certain serious medical conditions, including kidney or liver disease, some psychiatric illnesses, and stomach, lung, heart, hormonal, nerve or blood diseases
    • WHO performance status of 3 or 4
    • If you are participating in another trial with a different new drug 4 weeks before you enter this trial
    • Current participation in any other clinical study
    • Pregnant or breast-feeding women
    • Women of childbearing age who are unable or unwilling to use an IUD or hormonal birth control during the whole trial

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    University of Iowa Hospitals and Clinics
    Iowa City, Iowa, United States, 52242
    Status
    Study Complete
    Contact us

    Study documents

    No study documents available.

    Results overview

    Study Results yet to be posted

    Recruitment status
    Other
    Actual primary completion date
    2005-31-01
    Actual study completion date
    2005-08-11

    Plain language summaries

    Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

    Additional information about the trial

    Additional information
    Not applicable
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    Access to clinical trial data by researchers
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