Last updated: 11/07/2018 00:25:57

Open label Multicenter Study of CVP Followed by Iodine-131 Anti-B1 Antibody for subjects with Untreated Low-Grade Non Hodgkin's Lymphoma.

GSK study ID
104514
Clinicaltrials.gov ID
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 cyclophosphamide, vincristine, and prednisone (CVP) followed by Iodine-131 anti-B1 antibody for patients with untreated low-grade non-Hodgkin’s lymphoma (NHL).
Trial description: This is a phase II, open-label, multicenter study of the efficacy and safety of sequential administration of CVP x 6 followed by tositumomab and iodine I 131 tositumomab (formerly referred to as tositumomab and iodine I 131 tositumomab). All patients who complete three cycles of CVP, regardless of response, will be eligible for treatment with tositumomab and iodine I 131 tositumomab. Subjects who have rapidly progressive disease prior to completing three cycles of CVP may be removed from study.
In order to proceed to tositumomab and iodine I 131 tositumomab therapy, patients must have completed six cycles of CVP within 20 weeks as described. Patients may proceed to Iodine-131 Anti-B1 Antibody if they have progressive disease documented at the response evaluation following 6 cycles of CVP. In addition, patients must still meet the eligibility inclusion exclusion criteria based upon the week 20 assessments, as applicable. Patients must also have an average of ≤25% bone marrow involved by NHL to receive treatment with tositumomab and iodine I 131 tositumomab. The dosimetric dose of tositumomab and iodine I 131 tositumomab must be given within 28 days of the response evaluation following CVP and no later than 56 days from the first day of the sixth cycle of CVP.
Primary purpose:
Treatment
Trial design:
Single Group Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:

Number of participants (par.) with unconfirmed response (Complete Response, Complete Response/Unconfirmed, or Partial Response), as assessed by the Investigator

Timeframe: Par. were evaluated until death/disease progression or for 2 years in Study BEX104514. Par. who completed 2 years in Study BEX104514 were followed in Study BEX104528 for up to 130 months. Data are included from Study BEX104514 and Study BEX104528.

Number of participants (par.) with confirmed response (Complete Response [CR], Complete Response/Unconfirmed [CRu], or Partial Response [PR]), as assessed by the Investigator

Timeframe: Par. were evaluated until death/disease progression or for 2 years in Study BEX104514. Par. who completed 2 years in Study BEX104514 were followed in Study BEX104528 for up to 130 months. Data are included from Study BEX104514 and Study BEX104528.

Secondary outcomes:

Number of participants with unconfirmed Complete Response (CR), as assessed by the Investigator

Timeframe: Par. were evaluated until death/disease progression or for 2 years in Study BEX104514. Par. who completed 2 years in Study BEX104514 were followed in Study BEX104528 for up to 130 months. Data are included from Study BEX104514 and Study BEX104528.

Number of participants with confirmed Complete Response (CR), as assessed by the Investigator

Timeframe: Par. were evaluated until death/disease progression or for 2 years in Study BEX104514. Par. who completed 2 years in Study BEX104514 were followed in Study BEX104528 for up to 130 months. Data are included from Study BEX104514 and Study BEX104528.

Duration of response (DOR), as assessed by the Investigator

Timeframe: Par. were evaluated until death/disease progression or for 2 years in Study BEX104514. Par. who completed 2 years in Study BEX104514 were followed in Study BEX104528 for up to 130 months. Data are included from Study BEX104514 and Study BEX104528.

DOR for unconfirmed and confirmed complete response, as assessed by the Investigator

Timeframe: Par. were evaluated until death/disease progression or for 2 years in Study BEX104514. Par. who completed 2 years in Study BEX104514 were followed in Study BEX104528 for up to 130 months. Data are included from Study BEX104514 and Study BEX104528.

Time to progression of disease or death, as assessed by the Investigator

Timeframe: Par. were evaluated until death/disease progression or for 2 years in Study BEX104514. Par. who completed 2 years in Study BEX104514 were followed in Study BEX104528 for up to 130 months. Data are included from Study BEX104514 and Study BEX104528.

Time to treatment failure, as assessed by the Investigator

Timeframe: Par. were evaluated until death/disease progression or for 2 years in Study BEX104514. Par. who completed 2 years in Study BEX104514 were followed in Study BEX104528 for up to 130 months. Data are included from Study BEX104514 and Study BEX104528.

Total body residence time (TBRT; average amount of time TST spends in the body, calculated from the rate of TB clearance of radioactivity during the dosimetric dose [DD]) of Iodine 131 TST antibody following the DD

Timeframe: Day (D) 0; D 2, 3, or 4; and D 6 or 7

Time to nadir for hematological parameters: absolute neutrophil count (ANC), hemoglobin, platelets, and white blood cell (WBC) count

Timeframe: Up to 120 days following the therapeutic dose (given on Study Day 7, following the dosimetric dose) (or the dosimetric dose for participants who did not receive the therapeutic dose)

Time to recovery (TTR) to baseline (BL) for hematologic laboratory (lab.) evaluations

Timeframe: Up to 120 days following the therapeutic dose (given on Study Day 7, following the dosimetric dose) (or the dosimetric dose for participants who did not receive the therapeutic dose)

Nadir values for absolute neutrophil count (ANC)

Timeframe: Up to 120 days following the therapeutic dose (given on Study Day 7, following the dosimetric dose) (or the dosimetric dose for participants who did not receive the therapeutic dose)

Nadir values for hemoglobin

Timeframe: Up to 120 days following the therapeutic dose (given on Study Day 7, following the dosimetric dose) (or the dosimetric dose for participants who did not receive the therapeutic dose)

Nadir values for platelet count

Timeframe: Up to 120 days following the therapeutic dose (given on Study Day 7, following the dosimetric dose) (or the dosimetric dose for participants who did not receive the therapeutic dose)

Nadir values for WBC count

Timeframe: Up to 120 days following the therapeutic dose (given on Study Day 7, following the dosimetric dose) (or the dosimetric dose for participants who did not receive the therapeutic dose)

Number of participants with the indicated Grade 3 or Grade 4 Adverse Events (AEs)

Timeframe: Par. were evaluated until death/disease progression or for 2 years in Study BEX104514. Par. who completed 2 years in Study BEX104514 were followed in Study BEX104528 for up to 130 months. Data are included from Study BEX104514 and Study BEX104528.

Number of participants with the indicated Grade 3 or Grade 4 AEs possibly or probably related to study drug

Timeframe: Par. were evaluated until death/disease progression or for 2 years in Study BEX104514. Par. who completed 2 years in Study BEX104514 were followed in Study BEX104528 for up to 130 months. Data are included from Study BEX104514 and Study BEX104528.

Number of participants with any treatment-related serious adverse event (SAE)

Timeframe: Par. were evaluated until death/disease progression or for 2 years in Study BEX104514. Par. who completed 2 years in Study BEX104514 were followed in Study BEX104528 for up to 130 months. Data are included from Study BEX104514 and Study BEX104528.

Number of participants with the indicated primary cause of death

Timeframe: Par. were evaluated until death/disease progression or for 2 years in Study BEX104514. Par. who completed 2 years in Study BEX104514 were followed in Study BEX104528 for up to 130 months. Data are included from Study BEX104514 and Study BEX104528.

Number of participants who received any supportive care

Timeframe: Par. were evaluated until death/disease progression or for 2 years in Study BEX104514. Par. who completed 2 years in Study BEX104514 were followed in Study BEX104528 for up to 130 months. Data are included from Study BEX104514 and Study BEX104528.

Number of participants who were negative for human anti-murine antibodies (HAMA) at Baseline (study entry) but positive or negative at Month 24

Timeframe: Day 1 to Day 730 (24 months) after receiving the dosimetric dose

Overall Survival

Timeframe: Par. were evaluated until death/disease progression or for 2 years in Study BEX104514. Par. who completed 2 years in Study BEX104514 were followed in Study BEX104528 for up to 130 months. Data are included from Study BEX104514 and Study BEX104528.

Interventions:
  • Biological/vaccine: cycolophosphamide, vacristine, and pednisone (CVP) x6 cycles followed by tositumomab and iodine I 131 tositumomab.
  • Enrollment:
    30
    Primary completion date:
    2012-03-02
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Link BK, Martin P, Kaminski MS, Goldsmith SJ, Coleman M, Leonard JP. Cyclophosphamide, vincristine, and prednisone followed by tositumomab and iodine-131-tositumomab in patients with untreated low-grade follicular lymphoma: eight-year follow-up of a multicenter phase II study.. [J Clin Oncol]. 2010;28(18):3035-3041.
    Medical condition
    Lymphoma, Non-Hodgkin
    Product
    tositumomab
    Collaborators
    Not applicable
    Study date(s)
    February 2000 to February 2012
    Type
    Interventional
    Phase
    2

    Participation criteria

    Sex
    Female & Male
    Age
    18+ years
    Accepts healthy volunteers
    No
    • Subjects must have a histologically confirmed initial diagnosis of low-grade non-Hodgkin's B-cell lymphoma according to the International Working Formulation (IWF) (32) (i.e., small lymphocytic with or without plasmacytoid differentiation; follicular small cleaved cell; or follicular, mixed small cleaved and large cell).
    • Subjects must have Ann Arbor Stage III, Stage IV, or bulky Stage II disease at diagnosis. Bulky Stage II is defined as a mediastinal mass greater than one-third of the maximum chest diameter, or any other mass greater than or equal to 10 cm in maximum diameter.
    • Subjects who have received prior chemotherapy, biologic therapy, steroids, or radiation therapy as treatment for their NHL.
    • Subjects with active obstructive hydronephrosis.

    Trial location(s)

    This study does not involve prospective enrollment of participants.

    Study documents

    Clinical study report
    Available language(s): English
    Scientific result summary
    Available language(s): English

    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
    2012-03-02
    Actual study completion date
    2012-03-02

    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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