Last updated: 11/07/2018 03:57:22
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 GSK Clinical Study Register is no longer maintained for this study.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.

Ofatumumab in patients with relapsed/progressive Diffused Large B-Cell Lymphoma (DLBCL) ineligible for or relapse/progression after transplant

GSK study ID
111776
See study documents
Clinicaltrials.gov ID
NCT00622388
See results summary
EudraCT ID
2007-004190-26
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: An open-label, single-arm. multi-center phase 2 trial with ofatumumab in patients with relapsed/progressive Diffuse Large B-Cell Lymphoma (DLBCL) ineligible for transplant or relapse/progression after autologous transplant
Trial description: The purpose of this trial is to determine the effect of ofatumumab in patients with Diffused Large B-Cell Lymphoma (DLBCL) ineligible for transplant or relapsed after autologous transplant
Primary purpose:
Treatment
Trial design:
Single Group Assignment
Masking:
None (Open Label)
Allocation:
Non-randomized
Primary outcomes:

Number of participants with objective response

Timeframe: 6-month period from start of treatment (up to Week 24)

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

Timeframe: 6-month period from start of treatment (up to Week 24)

Secondary outcomes:

Duration of response

Timeframe: From date of start of treatment to 2 years or withdrawal

Progression-free survival (PFS)

Timeframe: From date of start of treatment to 2 years or withdrawal

Time to next Diffuse Large B-Cell Lymphoma (DLBCL) therapy

Timeframe: From date of start of treatment to 5 years or withdrawal

Overall Survival (OS)

Timeframe: From date of start of treatment to 5 years or withdrawal

Number of participants with positive human anti-human antibodies (HAHA) at Screening and at Visits 12, 13, 14, and 18

Timeframe: Screening visit (=<14 days before treatment start), Visit 12 (Month 6), Visit 13 (Month 9), Visit 14 (Month 12), and Visit 18 (Month 24)

Median percent change from Baseline in CD45+CD19+ and CD45+CD20+ cells in the peripheral blood at the indicated visits

Timeframe: Baseline and Visit 10 (Week 8), Visit 11 (Week 11), Visit 12 (Month 6), Visit 13 (Month 9), Visit 14 (Month 12), Visit 15 (Month 15), Visit 16 (Month 18), Visit 17 (Month 21), Visit 18 (Month 24), Visit 19 (Month 30), Visit 20 (Month 36)

Number of participants who experienced at least one adverse event (AE)

Timeframe: Time frame is from date of start of treatment to 2 years or withdrawal

Percent change from Screening in complement (CH50) levels

Timeframe: Screening and post-baseline visits (last visit was to occur 24 months post first dose)

AUC(0-inf) and AUC(0-168) for ofatumumab at the eighth infusion

Timeframe: Visit 9 (Week 7; up to 11 months after last dose)

Cmax and Ctrough for ofatumumab at the first and eighth infusions

Timeframe: Visit 2 (Week 0) and Visit 9 (Week 7)

Half-life (T1/2) for ofatumumab at the eighth infusion

Timeframe: Visit 9 (Week 7; up to 11 months after last dose)

Clearance (CL) of ofatumumab at the eighth infusion

Timeframe: Visit 9 (Week 7; up to 11 months after last dose)

Volume of distribution at steady state (Vss) of ofatumumab at the eighth infusion

Timeframe: Visit 9 (Week 7; up to 11 months after the last dose)

Interventions:
  • Drug: Ofatumumab
    • Enrollment:
    81
    Primary completion date:
    2010-31-05
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Bertrand Coiffier, John Radford, André Bosly, Giovanni Martinelli, Gabriela Barca, Andrew Davies, Didier Decaudin, Eve Gallop-Evans, Swaminathan Padmanabhan-Iyer, Koen Van Eygen, Ka Lung Wu, Ira V. Gupta, Thomas S. Lin, Nancy Goldstein, Roxanne C Jewel .Population Pharmacokinetics of the Ofatumumab in Combination with Chemotherapy in Relapsed or Refractory Aggressive Lymphoma.Br J Haematol.2013;163(3):334-342
    Medical condition
    Lymphoma, Large-Cell, Diffuse
    Product
    ofatumumab
    Collaborators
    Not applicable
    Study date(s)
    December 2007 to August 2014
    Type
    Interventional
    Phase
    2

    Participation criteria

    Sex
    Female & Male
    Age
    18+ years
    Accepts healthy volunteers
    No
    • Inclusion Criteria:
    • Patients with DLBCL
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Inclusion Criteria: Patients with DLBCL
    • and relapse after complete remission or disease progression after partial remission who are ineligible for autologous stem cell transplantation
    • and relapse after complete remission or disease progression after partial remission following autologous stem cell transplantation.

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    London, London, United Kingdom, EC1M 6BQ
    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
    2010-31-05
    Actual study completion date
    2014-18-08

    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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