Last updated: 11/03/2018 12:11:10
This product has been transferred to Novartis. GSK Clinical Study Register is no longer maintained for this study. The most up to date information is available on clinicaltrials.gov.

HuMax-CD20 i(Ofatumumab) n Follicular Lymphoma (FL) patients refractory to rituximab

GSK study ID
111772
See study documents
Clinicaltrials.gov ID
NCT00394836
See results summary
EudraCT ID
2006-001433-17
EU CT Number
Not applicable
Trial status
No longer a GSK study
No longer a GSK study
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: A single-arm, international, multi-center trial of HuMax-CD20, a fully human monoclonal anti-CD20 antibody, in patients with Follicular Lymphoma who are refractory to rituximab as monotherapy or in combination with chemotherapy
Trial description: A Single-Arm, International, Multi-Center Trial of HuMax-CD20 (Ofatumumab), a Fully Human Monoclonal Anti-CD20 Antibody, in Patients With Follicular Lymphoma Who Are Refractory to Rituximab as Monotherapy or in Combination With Chemotherapy
Primary purpose:
Treatment
Trial design:
Single Group Assignment
Masking:
Single (Outcomes Assessor)
Allocation:
Not applicable
Primary outcomes:

Number of participants with objective response (OR)

Timeframe: Start of treatment (Day 1 of Week 0) until 3 months after start of last infusion (up to Week 32)

Number of participants classified as responders and non-responders for objective response (OR)

Timeframe: 6-month period from the start of treatment. There was a median time of response at Month 5.5 (participants were followed for up to 24 months).

Secondary outcomes:

Duration of Response

Timeframe: From start of treatment (Week 0) until Month 24

Progression-Free Survival

Timeframe: From start of treatment (Week 0) until Month 24

Time to next follicular lymphoma (FL) therapy

Timeframe: From start of treatment (Week 0) until Month 24

Overall Survival

Timeframe: First dose (Week 0) until 5 years

Percent change from Screening (Visit 1) in tumor size as assessed by Radiologist 1 (R1) and Radiologist 2 (R2) at Months 3, 6, 9, 12, 18, and 24

Timeframe: Visits 1 (Week -2), 11 (Month 3), 12 (Month 6), 13 (Month 9), 14 (Month 12), 16 (Month 18), and 18 (Month 24)

Percent change from Baseline (Visit 2) in CD19+ and CD20+ cells in peripheral blood at Visits 11 and 12

Timeframe: Visits 2 (Baseline), 11 (Month 3), and 12 (Month 6)

Number of participants with conversion and no conversion of BCL2 positive to BCL2 negative in peripheral blood

Timeframe: Screening (Visit 1) until Month 24 (Visit 18)

Number of participants who experienced any adverse event from first treatment (Visit 2) to Visit 18 (Month 24)

Timeframe: From first treatment (Visit 2) until Visit 18 (Month 24)

Number of participants with positive human anti-human antibodies (HAHA) at Visits 1, 12, 13, and 14

Timeframe: Visits 1 (Screening), 12 (Month 6), 13 (Month 9), and 18 (Month 24)

Complement (CH50) levels at Visit 1 and at the end of infusion at Visit 2

Timeframe: Visits 1 (Week -2) and 2 (Week 0)

Number of participants classified as responders for Fragment C Receptor (FcR) polymorphism (poly.)

Timeframe: From first treatment (Visit 2) until Visit 12 (Month 6)

Ctrough and Cmax at the eighth infusion (Visit 9, Week 7)

Timeframe: Visit 9 (Week 7; up to 10 months after dose)

AUC(0-inf) and AUC(0-168) after the eighth infusion (Visit 9, Week 7)

Timeframe: Visit 9 (Week 7; up to 10 months after dose)

t1/2 after the eighth infusion (Visit 9, Week 7)

Timeframe: Visit 9 (Week 7; up to 10 months after dose)

CL after the eighth infusion (Visit 9, Week 7)

Timeframe: Visit 9 (Week 7; up to 10 months after dose)

Vss after the eighth infusion (Visit 9, Week 7)

Timeframe: Visit 9 (Week 7; to up 10 months after dose)

Interventions:
  • Drug: Ofatumumab
    • Enrollment:
    116
    Primary completion date:
    2009-21-04
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Czuczman MS, Fayad L, Delwail V, Cartron G, Jacobsen E, Kuliczkowski K, Link BK, Pinter-Brown L, Radford J, Hellmann A, Gallop-Evans E, DiRienzo CG, Goldstein N, Gupta I, Jewell RC, Lin TS, Lisby S, Schultz M, Russell CA, Hagenbeek A . Ofatumumab Monotherapy in Rituximab-Refractory Follicular Lymphoma: Results from a Multicenter Study . [Blood]. 2012;119(16):3698-3704.
    Medical condition
    Lymphoma, Follicular
    Product
    ofatumumab
    Collaborators
    Not applicable
    Study date(s)
    May 2007 to May 2013
    Type
    Interventional
    Phase
    2

    Participation criteria

    Sex
    Female & Male
    Age
    18+ years
    Accepts healthy volunteers
    No
    • Inclusion Criteria
    • Patient with follicular lymphoma grade 1 – 2
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Inclusion Criteria
    • Patient with follicular lymphoma grade 1 – 2
    • Refractory to rituximab given as monotherapy or in combination with any chemotherapy or to rituximab given as maintenance treatment following R-chemo, defined as:
    • failure to achieve at least PR to rituximab given as monotherapy or in combination with any chemotherapy; or,
    • disease progression while on rituximab (either given as monotherapy or in combination with any chemotherapy or during rituximab maintenance treatment following R-chemo); or,
    • disease progression in responders within 6 months of the last dose of rituximab (either given as monotherapy or in combination with any chemotherapy or after rituximab maintenance treatment schedule following R-chemo)
    • Tumor verified to be CD20+ positive from excisional lymph node biopsy
    • CT scan in screening phase (based on local evaluation) showing:
    • 2 or more clearly demarcated lesions with a largest diameter ≥ 1.5 cm, or
    • 1 clearly demarcated lesion with a largest diameter ≥ 2,0 cm
    • ECOG Performance Status of 0, 1, or 2
    • Age ≥ 18 years
    • Following receipt of verbal and written information about the study, the patient must provide signed informed consent before any study related activity is carried out Exclusion Criteria
    • Previous autologous stem cell transplantation within 6 months
    • Previous allogeneic stem cell transplantation
    • More than 1 previous radio immunotherapy regimen
    • Received radio immunotherapy within 3 months
    • Received any Anti-cancer treatment within 4 weeks
    • Received monoclonal antibodies, other than rituximab within 3 months
    • Patients previously treated with anti-CD20 monoclonal antibodies, other than rituximab
    • Life expectancy less than 6 months

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Southampton, United Kingdom, SO16 6YD
    Status
    Study Complete
    Contact us

    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
    No longer a GSK study
    Actual primary completion date
    2009-21-04
    Actual study completion date
    2013-23-05

    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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    Access to clinical trial data by researchers
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