Last updated: 11/04/2018 08:15:28

HuMax-CD20 in Chronic Lymphocytic Leukemia

GSK study ID
Hx-CD20-402
Clinicaltrials.gov ID
NCT00093314
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-labeled, International, Multicenter, Dose Escalating, Phase I/II Trial of HuMax-CD20, a Fully Human Monoclonal Anti-CD20 Antibody, in Patients with Relapsed or Refractory Chronic Lymphocytic Leukemia
Trial description: The purpose of this trial is to determine the safety and efficacy of HuMax-CD20 as a treatment for Chronic Lymphocytic Leukemia.
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:
    2007-31-01
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Not applicable
    Medical condition
    Chronic Lymphocytic Leukemia
    Product
    Not applicable
    Collaborators
    Not applicable
    Study date(s)
    October 2004 to January 2007
    Type
    Interventional
    Phase
    1/2

    Participation criteria

    Sex
    Female & Male
    Age
    18+ years
    Accepts healthy volunteers
    No
    • Chronic Lymphocytic Leukemia
    • Circulating lymphocytes above a specific level
    • Previous treatment with rituximab or alemtuzumab within 6 months prior to enrollment in study.
    • Previous stem cell transplantation.
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Chronic Lymphocytic Leukemia
    • Circulating lymphocytes above a specific level
    • Circulating lymphocytes showing certain markers
    Exclusion criteria:
    • Previous treatment with rituximab or alemtuzumab within 6 months prior to enrollment in study.
    • Previous stem cell transplantation.
    • Received any of the following treatments within 4 weeks prior to entering this trial: A) Anti-cancer therapy, B) Glucocorticoids unless less than 10 mg per day, C) Radiotherapy.
    • HIV positivity.
    • Hepatitis B or hepatitis C.
    • Other cancerous diseases, except certain skin cancers and cervix cancer.
    • Certain serious medical conditions, including kidney or liver disease, some psychiatric illnesses, and stomach, heart, hormonal, nerve or blood diseases.
    • Participation in another trial with a different new drug 4 weeks prior to enrollment in study.
    • Current participation in any other clinical study.
    • Pregnant or breast-feeding women.
    • Women of childbearing age who are unable or unwilling to use adequate contraception.

    Trial location(s)

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

    Study documents

    No study documents available.

    Results overview

    Study Results yet to be posted

    Recruitment status
    Other
    Actual primary completion date
    2007-31-01
    Actual study completion date
    2007-31-01

    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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