Last updated: 11/07/2018 15:56:31

Expanded Access Study Of BEXXAR® For Low Grade And Transformed Low-Grade Non-Hodgkin's Lymphoma

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GSK study ID
BEX104545
See study documents
Clinicaltrials.gov ID
NCT00268203
See results summary
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: Expanded Access Study of Iodine I 131 Tositumomab for Relapsed/Refractory Low-Grade and Transformed Low-Grade Non-Hodgkin's Lymphoma
Trial description: This is a single arm, multi-center, expanded access study of Iodine I 131 Tositumomab (BEXXAR) therapeutic regimen for patients with relapsed or refractory low-grade or transformed low-grade non-Hodgkin's B-cell lymphoma. The primary objective is to make Iodine I 131 Tositumomab more broadly available to patients. Secondary endpoints will be to obtain additional safety and efficacy information for this treatment regimen. Post study drug administration follow-ups will continue for up to ten years. These will include blood-work and adverse event assessments for 13 weeks post dosing, patient response evaluations at Week 13, Months 6, 12, 18, 24, and Long-Term Follow-ups every 6 months until the elapse of 5 years from the dosimetric dose and then annually thereafter through year 10. Thyroid function will be monitored annually during Long-term follow-up.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

Number of participants with unconfirmed response (complete response or partial response) and unconfirmed complete response

Timeframe: From randomization until the first documented complete response or partial response (up to 161 months)

Number of participants with confirmed response (complete response or partial response) and confirmed complete response

Timeframe: From randomization until the first documented complete response or partial response (up to 161 months)

Duration of response for participants with unconfirmed response (CR+PR)

Timeframe: From the time of the first documented response (CR or PR) until disease progression (up to 161 months)

Duration of response for participants with confirmed response (CR+PR)

Timeframe: From the time of the first documented response (CR or PR) until disease progression (up to 161 months)

Duration of response (DOR) in unconfirmed complete responders

Timeframe: From the time of the first documented unconfirmed CR until PD (up to 161 months)

Duration of response (DOR) in confirmed complete responders

Timeframe: From the time of the first documented CR until PD (up to 161 months)

Time to progression or death

Timeframe: From the treatment start date to the first documented incidence of disease progression (PD) or death (up to 161 months)

Secondary outcomes:

Time to treatment failure

Timeframe: From the dosimetric dose to the first occurrence of the following: treatment withdrawal, decision to seek additional therapy, study removal, disease progression, receipt of alternative therapy, or death (up to 161 months)

Interventions:
  • Biological/vaccine: Iodine I 131 Tositumomab Therapeutic Regimen
    • Enrollment:
    765
    Primary completion date:
    2000-31-03
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Franz Buchegger, Cristian Antonescu, Claudine Helg, Marek Kosinski, John O. Prior, Angelika Bischof Delaloye, Oliver W. Press and Nicolas Ketterer.Six of 12 relapsed/refractory indolent lymphoma patients treated 10 years ago with 131I-tositumomab remain in complete remission.J Nucl Med.2011;52:896–900
    Medical condition
    Lymphoma, Non-Hodgkin
    Product
    Not applicable
    Collaborators
    Not applicable
    Study date(s)
    September 1998 to February 2013
    Type
    Interventional
    Phase
    2

    Participation criteria

    Sex
    Female & Male
    Age
    18+ years
    Accepts healthy volunteers
    Not applicable
    • Histologically confirmed diagnosis of low- grade NHL or transformed low-grade NHL (tumor must be CD 20 positive).
    • Prior treatment with at least one chemotherapy regimen and have relapsed or progressed, or failed to achieve an objective response on last chemotherapy regimen.
    • Patients with a mean of >25% of the intratrabecular marrow space involved with lymphoma.
    • Patients who received cytotoxic chemotherapy, radiation therapy, immunotherapy, or cytokine treatment within 4 weeks prior to study entry (6 weeks for nitrosurea compounds) or who exhibit persistent clinical evidence of toxicity.
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Histologically confirmed diagnosis of low- grade NHL or transformed low-grade NHL (tumor must be CD 20 positive).
    • Prior treatment with at least one chemotherapy regimen and have relapsed or progressed, or failed to achieve an objective response on last chemotherapy regimen.
    • Karnofsky performance status of at least 60% and anticipated survival of at least 3 months.
    • Absolute granulocyte of >/= 1,500/mm3.
    • Platelet count of >/= 100,000/mm3, and not require sustained support of hematopoietic cytokines, or transfusion of blood products.
    • Adequate renal function (i.e., <1.5x Upper Limit of Normal), and hepatic transaminases (AST <5 times ULN).
    • Signed IRB/IEC-approved informed consent.
    Exclusion criteria:
    • Patients with a mean of >25% of the intratrabecular marrow space involved with lymphoma.
    • Patients who received cytotoxic chemotherapy, radiation therapy, immunotherapy, or cytokine treatment within 4 weeks prior to study entry (6 weeks for nitrosurea compounds) or who exhibit persistent clinical evidence of toxicity.
    • Patients who have undergone stem cell or bone marrow transplant, active obstructive hydronephrosis, active infection, New York Heart Association Class III or IV heart disease or other serious illness that would preclude evaluation.
    • Known HIV infection.
    • Pregnant or nursing patients.
    • Patients with prior malignancy other than lymphoma, except for adequately-treated skin cancer, in-situ cervical cancer, or cancer for which the patient has been disease-free for 5 years.
    • Patients with progressive disease within 1 year of irradiation arising in a field that has been previously irradiated with more than 3500 cGy.
    • Patients who received prior radioimmunotherapy, known brain or leptomeningeal metastases, HAMA positivity.
    • Patients who are receiving either approved or non-approved (through another protocol) anti-cancer drugs or biologics.

    Trial location(s)

    This study does not involve prospective enrollment of participants.

    Study documents

    Scientific result summary
    Available language(s): English
    Download document(s)

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Results posted on ClinicalTrials.gov

    Recruitment status
    Study complete
    Actual primary completion date
    2000-31-03
    Actual study completion date
    2013-28-02

    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

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