Last updated: 01/19/2024 16:50:13

Comparative Trial between Bexxar and Zevalin

GSK study ID
CCBX001-053
Clinicaltrials.gov ID
NCT00319332
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Will be recruiting
Will be recruiting
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: A Multi-Center, Randomized, Phase III Study of Iodine I 131 Tositumomab Therapeutic Regimen versus Ibritumomab Tiuxetan Therapeutic Regimen for Patients with Relapsed or Transformed Follicular Non-Hodgkin's Lymphoma
Trial description: The primary purpose of this trial is to compare safety and efficacy between Bexxar and Zevalin.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:
Not applicable
Secondary outcomes:
Not applicable
Interventions:
  • Drug: Bexxar - Iodine I 131 Tositumomab Therapeutic Regimen
  • Drug: Zevalin - Ibritumomab Tiuxetan Therapeutic Regimen
    • Enrollment:
    350
    Primary completion date:
    Not applicable
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Not applicable
    Medical condition
    Follicular Lymphoma
    Product
    tositumomab
    Collaborators
    Not applicable
    Study date(s)
    N/A to Invalid Date
    Type
    Interventional
    Phase
    3

    Participation criteria

    Sex
    Female & Male
    Age
    18+ years
    Accepts healthy volunteers
    No
    • Inclusion Criteria
    • A histologically confirmed diagnosis of follicular lymphoma, Grade 1, 2, or 3, or diffuse large cell lymphoma concurrent with or following the diagnosis of follicular lymphoma (WHO/REAL classification).
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Inclusion Criteria
    • A histologically confirmed diagnosis of follicular lymphoma, Grade 1, 2, or 3, or diffuse large cell lymphoma concurrent with or following the diagnosis of follicular lymphoma (WHO/REAL classification).
    • Recurrent lymphoma after at least three qualifying therapy regimens including at least one Rituximab-containing regimen and at least one chemotherapy regimen. The patient must have either not responded or responded with a duration of response of less than 6 months to a Rituximab-containing regimen.
    • Performance status of at least 70% on the Karnofsky Scale and an anticipated survival of at least three months.
    • Bi-dimensionally measurable disease with at least one lesion measuring >= 4.0 cm2 by CT scan.
    • Absolute neutrophil count >=1500 cells/mm3 and a platelet count >= 100,000/mm3.
    • Adequate renal function (defined as serum creatinine <1.5 x upper limit of normal) and adequate hepatic function (defined as total bilirubin <1.5x upper limit of normal and AST <5x upper limit of normal).
    • Human Anti-Murine Antibody (HAMA) negative. Exclusion Criteria
    • Greater than 25% of the intratrabecular marrow space involved by lymphoma in bone marrow biopsy specimens.
    • Hypocellular bone marrow (<=15% cellularity or marked reduction in bone marrow precursors).
    • Prior myeloablative therapy.
    • History of failed stem cell collection.
    • Prior radiotherapy to fields encompassing more than 25% of the blood-forming marrow.
    • Prior chemotherapy, biologic therapy, radiation therapy, or steroid therapy for non-Hodgkin's lymphoma (NHL) within eight weeks prior to screening procedures. Patients receiving low doses of steroids for non-neoplastic indications may enter the study (“low dose steroids” is defined as <=10 mg of prednisone or equivalent per day.)
    • Prior radioimmunotherapy.
    • Prior treatment of any non-human, particularly murine monoclonal or polyclonal antibodies for either diagnostic or therapeutic purposes. This prohibition does not extend to the chimeric monoclonal antibody, Rituximab.
    • Prior malignancy other than lymphoma, except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer for which the patient has been disease-free for five years.
    • Evidence of active infection requiring IV antibiotics at the time of study enrollment.
    • New York Heart Association (NYHA) class III or IV heart disease or other serious illness that would preclude evaluation.
    • Known HIV infection.
    • Known brain or leptomeningeal metastases.
    • Active obstructive hydronephrosis.
    • Evidence of ascites observed at screening physical examination.
    • Known type I hypersensitivity or anaphylactic reactions to murine proteins or to any component of the Ibritumomab Tiuxetan therapeutic regimen, including Rituximab, Ibritumomab Tiuxetan, Yttrium Chloride, and Indium Chloride, or any component of the Iodine I 131 Tositumomab therapeutic regimen.
    • Pregnant or nursing patients.

    Trial location(s)

    This study does not involve prospective enrollment of participants.

    Study documents

    No study documents available.

    Results overview

    Study Results yet to be posted

    Recruitment status
    Will be recruiting
    Actual primary completion date
    Not applicable
    Actual study completion date
    Not applicable

    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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