Last updated: 11/03/2018 12:12:29
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 GSK Clinical Study Register is no longer maintained for this study.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 in B-Cell Chronic Lymphocytic Leukemia (B-CLL) patients failing fludarabine and alemtuzumab

GSK study ID
111773
See study documents
Clinicaltrials.gov ID
NCT00349349
See results summary
EudraCT ID
2005-006163-31
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 B-cell Chronic Lymphocytic Leukemia who have failed fludarabine and alemtuzumab
Trial description: The purpose of this study is to determine whether HuMax-CD20 (ofatumumab) is effective in the treatment of patients failing both fludarabine and alemtuzumab.
Primary purpose:
Treatment
Trial design:
Single Group Assignment
Masking:
None (Open Label)
Allocation:
Non-randomized
Primary outcomes:

Number of participants (par.) classified as responders and non-responders for objective response as assessed by an Independent Endpoint Review Committee (IRC) in accordance with the National Cancer Institute Working Group (NCIWG) 1996 guidelines

Timeframe: Start of treatment (Week 0 of Visit 2) until Week 24

Secondary outcomes:

Duration of response

Timeframe: Start of treatment (Week 0 of Visit 2) until Week 24

Progression-Free Survival (PFS)

Timeframe: Start of treatment (Week 0 of Visit 2) until Week 24

Time to next chronic lymphocytic leukemia (CLL) treatment

Timeframe: Time from randomization (Week 0 of Visit 2) until the time of first administration of a CLL treatment other than ofatumumab (assessed for a median of 8.7 weeks currently [or up to 13.3 months])

Overall Survival

Timeframe: Start of randomization (Week 0 of Visit 2) until death (up to a median of 17.1 weeks)

Percent change from Baseline to Week 7 in peripheral CD5+CD19+ cell counts

Timeframe: Baseline (Visit 2) until Week 7 (Visit 9)

Percent change from Baseline to Week 7 in peripheral CD5+CD20+ cell counts

Timeframe: Baseline (Visit 2) until Week 7 (Visit 9)

Median percent change of tumor size (sum of products dimensions [SPD]) from Baseline (Visit 2) to Week 24 (Visit 14)

Timeframe: Baseline (Visit 2) until Week 24 (Visit 14)

Number of participants with complete resolution of constitutional symptoms at Week 24

Timeframe: Baseline (Visit 2) and Week 24

Number of participants with complete resolution of lymphadenopathy

Timeframe: Baseline (Visit 2) to end of study (up to Week 24)

Number of participants with improvement on the Eastern Cooperative Oncology Group (ECOG) performance status scale at Week 24

Timeframe: Baseline (Visit 2) and Week 24

Number of participants who were positive, negative, or had missing data for the indicated fluorescence in situ hybridization (FISH) prognostic factors at Screening

Timeframe: Screening (Visit 1, <=14 days prior to Visit 2)

Number of participants with improvement in hemoglobin

Timeframe: Baseline (Visit 2) to Week 28

Number of participants with improvement in thrombocytopenia (thromb.)

Timeframe: Baseline (Visit 2) to Week 28

Number of participants with complete resolution of hepatomegaly

Timeframe: Baseline (Visit 2) until Week 24

Number of participants with improvement in neutropenia

Timeframe: Baseline (Visit 2) to Week 28

Number of participants with complete resolution of splenomegaly

Timeframe: Baseline (Visit 2) until Week 24

Number of participants who experienced any adverse event

Timeframe: From first infusion (Visit 2/Week 0) to Visit 21 (Month 24 of follow-up [up to Month 48]) or time of withdrawal (treatment and follow-up)

Cmax and Ctrough at Dose 1 (Visit 2, Week 0), Dose 8 (Visit 9, Week 7), and Dose 12 (Visit 14, Week 24)

Timeframe: Visit 2 (Week 0), Visit 9 (Week 7), and Visit 14 (Week 24)

AUC (0-inf) and AUC(0-tau) at Dose 8 (Visit 9, Week 7) and Dose 12 (Visit 14, Week 24)

Timeframe: Visit 9 (Week 7) and Visit 14 (Week 24)

Half-life (t1/2) at Dose 8 (Visit 9, Week 7) and at Dose 12 (Visit 14, Week 24)

Timeframe: Visit 9 (Week 7) and Visit14 (Week 24)

Clearance (CL) after Dose 8 (Visit 9, Week 7) and Dose 12 (Visit 14, Week 24)

Timeframe: Visit 9 (Week 7) and Visit 14 (Week 24)

Volume of distribution at steady state (Vss) at Dose 8 (Visit 9, Week 7) and at Dose 12 (Visit 14, Week 24)

Timeframe: Visit 9 (Week 7) and Visit 14 (Week 24)

Interventions:
  • Drug: ofatumumab
    • Enrollment:
    223
    Primary completion date:
    2008-19-05
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Wierda WG, Kipps T, Mayer J, Stilgenbauer S, Williams CD, Hellmann A, Robak T, Furman R, Hillmen P, Trneny M, Dyer M, Padmanabhan S, Piotrowska M, Kozak T, Chan G, Davis R, Losic N, Russell C, Wilms J, Osterborg A. Ofatumumab as single-agent CD20 immunotherapy in fludarabine-refractory chronic lymphocytic leukemia. [J Clin Oncol]. 2010;28(10):1749-1755.
    Wierda WG, Padmanabhan S, Chan GW, Gupta IV, Lisby S and Osterborg A . Ofatumumab is active in patients with fludarabine-refractory chronic lymphocytic leukemia irrespective of prior rituximab: Results from the phase II international study. [Blood]. 2011;118(19):5126-5129.
    Medical condition
    Leukaemia, Lymphocytic, Chronic
    Product
    ofatumumab
    Collaborators
    Not applicable
    Study date(s)
    June 2006 to June 2012
    Type
    Interventional
    Phase
    2

    Participation criteria

    Sex
    Female & Male
    Age
    18+ years
    Accepts healthy volunteers
    No
    • 1) Tumor cell phenotype consistent with B-CLL
    • 2) Patients with active B-CLL and with an indication for treatment
    • 1) Previous treatment with alemtuzumab within 6 weeks prior to Visit 2
    • 2) Previous autologous stem cell transplantation within 6 months prior to Visit 2
    Inclusion and exclusion criteria
    Inclusion criteria:
    • 1) Tumor cell phenotype consistent with B-CLL 2) Patients with active B-CLL and with an indication for treatment 3) Failing at least one fludarabine-containing treatment regimen 4) Failing at least one alemtuzumab-containing treatment regimen 5) ECOG Performance Status of 0, 1, or 2 6) Life expectancy of at least 4 months
    Exclusion criteria:
    • 1) Previous treatment with alemtuzumab within 6 weeks prior to Visit 2 2) Previous autologous stem cell transplantation within 6 months prior to Visit 2 3) Allogeneic stem cell transplantation 4) Radioimmunotherapy

    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
    No longer a GSK study
    Actual primary completion date
    2008-19-05
    Actual study completion date
    2012-08-06

    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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