Last updated: 11/07/2018 14:19:31

Iodine-131 Anti-B1 Antibody Consolidation for Patients with Non-Hodgkin's Lymphoma Following First-line CHOP

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GSK study ID
393229/007
See study documents
Clinicaltrials.gov ID
NCT01868035
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: Phase II Multicenter Study of Iodine-131 Anti-B1 Antibody Consolidation For Patients With Diffuse Large B-Cell Non-Hodgkin’s Lymphoma Following First-line CHOP
Trial description: This is a multicenter study for the long-term follow-up of surviving patients who are expected to complete or who have completed at least two years of follow-up after treatment with Iodine I 131 Tositumomab (BEXXAR) on studies CP-97-011, CP-98-025, CP-99-032, or CP-99-036. All patients will be assessed for survival and disease status, including subsequent therapy for Diffuse Large B-cell Non-Hodgkin's Lymphoma (NHL), and for long-term safety. Additionally laboratory evaluations consisting of a thyroid stimulating hormone (TSH) level and a complete blood cell (CBC) count with a differential and platelet count will be obtained annually. Additionally, patients who remain in long-term response following Iodine I 131 Tositumomab treatment will be followed for response and progression.
Primary purpose:
Treatment
Trial design:
Single Group Assignment
Masking:
None (Open Label)
Allocation:
Not applicable
Primary outcomes:

Number of participants with the indicated Grade 4 hematology toxicities following Iodine-131 Anti-B1 antibody

Timeframe: From Baseline until Week 25 and follow-up (up to 130 months)

Secondary outcomes:

Number of participants (par.) with confirmed (con.) complete response (CR) confirmed, confirmed complete response unconfirmed (CRu), confirmed partial response (PR), relapse disease (RD), and progressive disease (PD)

Timeframe: From Baseline until Week 25 and follow-up (up to 130 months)

Duration of response and duration of confirmed complete response

Timeframe: From Baseline until Week 25 and follow-up (up to 130 months)

Progression-free survival (PFS)

Timeframe: From Baseline until Week 25 and follow-up (up to 130 months)

Time to treatment failure (TTF)

Timeframe: From Baseline until Week 25 and follow-up (up to 130 months)

Total body residence time (TBRT)

Timeframe: From Baseline until Week 25 and follow-up (up to 130 months)

Number of participants with an adverse experience, including adverse events (AEs) and serious adverse events (SAEs)

Timeframe: From Baseline until Week 25 and follow-up (up to 130 months)

Time to recovery from the indicated hematology toxicities

Timeframe: From Baseline until Week 25 and follow-up (up to 130 months)

Nadir for the indicated hematology toxicities

Timeframe: From Baseline until Week 25 and follow-up (up to 130 months)

Time to nadir for the indicated hematology toxicities

Timeframe: From Baseline until Week 25 and follow-up (up to 130 months)

Number of participants needing supportive care at Week 7 and Week 13

Timeframe: Week 7 and Week 13

Number of participants converting to Human Anti-Murine (mouse) Antibody (HAMA) positivity at any follow-up visit from HAMA negativity at Baseline

Timeframe: Baseline; any follow-up visit (up to 72 months)

Overall survival

Timeframe: From Baseline until Week 25 and follow-up (up to 130 months)

Interventions:
  • Drug: tositumomab and iodine I-131 tositumomab
    • Enrollment:
    15
    Primary completion date:
    2012-25-10
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    John P Leonard, Stephanie A Gregory, Hedy Smith , Thierry J Horner, Vanessa C Williams, Patricia Giampietro, Thomas S Lin. CHOP chemotherapy followed by tositumomab and iodine-131 tositumomab for previously untreated diffuse large B-cell lymphoma. Clin Lymphoma Myeloma. 2016;16(4):191-196
    Medical condition
    Lymphoma, Non-Hodgkin
    Product
    tositumomab
    Collaborators
    Not applicable
    Study date(s)
    May 2000 to October 2012
    Type
    Interventional
    Phase
    2

    Participation criteria

    Sex
    Female & Male
    Age
    18+ years
    Accepts healthy volunteers
    No
    • male or female subjects age 18 to 80 years, inclusive, with any International Prognostic Index score; treated with 6 or more cycles of first-line CHOP chemotherapy and achieved a PR, CRu, or CR
    • de novo diffuse large B-cell NHL according to the REAL classification; Ann Arbor stage III, stage IV, or bulky stage II disease (any mass ≥10 cm in diameter)
    • prior radiation, prior biological therapy, or prior chemotherapy other than first-line CHOP
    • active bilateral obstructive hydronephrosis
    Inclusion and exclusion criteria
    Inclusion criteria:
    • male or female subjects age 18 to 80 years, inclusive, with any International Prognostic Index score; treated with 6 or more cycles of first-line CHOP chemotherapy and achieved a PR, CRu, or CR
    • de novo diffuse large B-cell NHL according to the REAL classification; Ann Arbor stage III, stage IV, or bulky stage II disease (any mass ≥10 cm in diameter)
    • less than an average of 25% of the intratrabecular marrow space involved by NHL in bilateral bone marrow biopsy specimens or <10% involvement with NHL from unilateral bone marrow biopsy; tumor tissue expressing the CD20 antigen
    • ≥60% performance status on the Karnofsky Performance Scale and an anticipated survival of at least 3 months
    • absolute neutrophil count (ANC) ≥1500 cells/mm3 and platelet count ≥100,000/mm3
    • adequate renal function (serum creatinine <1.5 × upper limit of normal [ULN]) and hepatic function (total bilirubin ≤2.0 × ULN and aspartate aminotransferase <5 × ULN)
    Exclusion criteria:
    • prior radiation, prior biological therapy, or prior chemotherapy other than first-line CHOP
    • active bilateral obstructive hydronephrosis
    • New York Heart Association class III or IV heart disease or other serious illness
    • prior malignancy other than lymphoma (except for adequately treated skin cancer, in situ cervical cancer, or other cancer for which they had been disease-free for >5 years)
    • human immunodeficiency virus infection
    • HAMA positive
    • brain or leptomeningeal metastases at any time since diagnosis
    • active infection requiring intravenous anti-infectives
    • pregnant or breastfeeding

    Trial location(s)

    This study does not involve prospective enrollment of participants.

    Study documents

    Clinical study report
    Available language(s): English
    Download document(s)
    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
    2012-25-10
    Actual study completion date
    2012-25-10

    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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