Last updated: 11/03/2018 11:18:37
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 GSK Clinical Study Register is no longer maintained for this study.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 Added to Fludarabine-Cyclophosphamide vs. Fludarabine-Cyclophosphamide Combination in Relapsed subjects with Chronic Lymphocytic Leukemia

GSK study ID
110913
See study documents
Clinicaltrials.gov ID
NCT00824265
EudraCT ID
2008-005811-16
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 Phase III, Open Label, Randomized Trial of Ofatumumab Added to Fludarabine-Cyclophosphamide vs. Fludarabine-Cyclophosphamide Combination in Subjects with Relapsed Chronic Lymphocytic Leukemia
Trial description: The purpose of this study is to evaluate the safety and efficacy of ofatumumab added to fludarabine-cyclophosphamide in patients with relapsed Chronic Lymphocytic Leukemia (CLL).
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:

Progression-free survival (PFS), as assessed by the Independent Review Committee (IRC)

Timeframe: From randomization up to 5 years after last dose of study drug

Secondary outcomes:

Number of participants who were negative for Minimal Residual Disease (MRD) assessed by IRC

Timeframe: From randomization up to 5 years after last dose of study drug

Maximum concentration (Cmax) and observed drug concentration prior to the next dose (Ctrough) of Ofatumumab

Timeframe: Cycle 1 Week 1, Cycle 1 Week 2, Cycles 2,3,4,5

Change from baseline in the European organization for the research and treatment of cancer quality of life questionnaire core 30 (EORTC QLQ-C30) score

Timeframe: Screening, Cycle 3 Day 1, and 1 M and every 3 month post last dose up to 24 month.

Percentage of participants with the best OR, as assessed by the Investigator

Timeframe: From randomization up to 5 years after last dose of study drug

Mean area under the time-concentration curve (AUC) curve over the dosing interval (AUC[0-tau]) of ofatumumab

Timeframe: Cycle 1 Week 1, Cycle 1 Week 2, Cycles 2,3,4,5,6

Mean level of Immunoglobulin (Ig) Antibodies IgA, IgG, and IgM

Timeframe: Baseline, 1M and 6M follow up

Number of participants who were negative for MRD assessed by investigator

Timeframe: From randomization up to 5 years after last dose of study drug

Number of participants with any Adverse Event (AE) or Serious Adverse Event (SAE)

Timeframe: From first dose of study medication to 60 Days after the last dose of study medication (for an AE), or up to 5 years after the last dose of study drug or until the time of the next anti-CLL therapy (for SAE)

Time of occurrence of Cmax (Tmax) of ofatumumab

Timeframe: Cycle 1 Week 1, Cycle 1 Week 2, Cycle 4

Number of Participants with no B-Symptoms or at least one B-symptoms over the time

Timeframe: Screening, Cycle1 Day 1, Cycle 2 Day1, Cycle 3 Day1, Cycle 4 Day1, Cycle 5 Day1, Cycle 6 Day 1 and During at 1M after study drug therapy, then every 3 M up to 5 year (up to 60 months)

Change from Baseline in Cell Counts, CD5- CD19+

Timeframe: Screening, Cycle 1 Day1, Cycle 1 Day 15, Cycle 2 Day 1, Cycle 2 Day 15, Cycle 3 Day 1, Cycle 4 Day 1, Cycle 5 Day 1, Cycle 6 Day 1 and after last dose at 1 M and then every three month up to 45 M during Follow-up Period

Overall survival (OS)

Timeframe: From randomization up to 5 years after last dose of study drug

Time to response, as assessed by the IRC

Timeframe: From randomization up to 5 years after last dose of study drug

Percentage of participants with the best Overall Response (OR), as assessed by the IRC

Timeframe: From randomization up to 5 years after last dose of study drug

Duration of Response (DOR), as assessed by the IRC

Timeframe: From time of initial response to disease progression or death, whichever came first (up to 5 years after the last dose of study drug)

Changes in Patient Reported Outcome (PRO) measures and scores for European organization for research and treatment of cancer quality of life questionnaire, chronic lymphocytic leukaemia 16 item module (EORTC QLQ-CLL 16)

Timeframe: Screening, Cycle 3 Day 1, and 1 M and every 3 month post last dose up to 24 month.

Change from baseline in Cluster of Differentiation (CD) Cell Counts, CD5+ and CD19+

Timeframe: Screening, Cycle 1 Day1, Cycle 1 Day 15, Cycle 2 Day 1, Cycle 2 Day 15, Cycle 3 Day 1, Cycle 4 Day 1, Cycle 5 Day 1, Cycle 6 Day 1 and after last dose at 1 M and then every three months up to 45 M during Follow-up Period

Prognostic and biological markers correlating with clinical response

Timeframe: From randomization up to 5 years after last dose of study drug

Time to progression, as assessed by the IRC

Timeframe: From randomization up to 5 years after the last dose of study drug

Number of participants with improvement in Eastern Cooperative Oncology Group (ECOG) performance status

Timeframe: Cycle 2 Day1, Cycle 3 Day1, Cycle 4 Day1, Cycle 5 Day1, Cycle 6 Day1, follow up (FU) at 1Month (M) after study drug therapy, then every 3 month up to 5 year (up to 60 months)

Number of participants with drug related AEs and SAEs of maximum severity of Grade 3 or Higher

Timeframe: From first dose of study medication to 60 days after the last dose of study medication (for an AE), or up to 5 years after the last dose of study drug or until the time of the next anti-CLL therapy (for SAE)

Time to next therapy

Timeframe: From the start of study drug until the start of the next anti-CLL therapy (up to 5 years after the last dose of study drug)

Number of Participants With a Human Anti-human Antibody (HAHA) Positive Result at indicated time points

Timeframe: From start of study drug until 60 days after the last dose of study medication

Number of participants who received no transfusion or at Least One transfusion during the study

Timeframe: From randomization up to 5 years after last dose of study drug

Mean of Health Change Questionnaire (HCQ)

Timeframe: Screening, Cycle 3 Day 1, and 1 M and every 3 month post last dose up to 24 month.

Change from Baseline in Patient Reported Outcome (PRO) as assessed by EuroQoL Five-Dimension (EQ-5D) score at indicated visit

Timeframe: Screening, Cycle 3 Day 1, and 1 M and every 3 month post last dose up to 24 month.

Number of participants with Autoimmune Hemolytic Anaemia (AIHA)

Timeframe: From first dose of study medication to 60 days after the last dose of study medication (for an AE), or up to 5 years after the last dose of study drug or until the time of the next anti-CLL therapy (for SAE)

Number of participants with at least one Grade 3/Grade 4 myelosuppression (Anemia, Neutropenia, and Thrombocytopenia)

Timeframe: From first dose of study medication to 60 days after the last dose of study medication (for an AE), or up to 5 years after the last dose of study drug or until the time of the next anti-CLL therapy (for SAE)

Interventions:
  • Drug: FC infusion
  • Drug: OFC Infusion
    • Enrollment:
    365
    Primary completion date:
    2014-17-12
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Not applicable
    Medical condition
    Leukaemia, Lymphocytic, Chronic
    Product
    ofatumumab
    Collaborators
    Not applicable
    Study date(s)
    March 2009 to July 2017
    Type
    Interventional
    Phase
    2/3

    Participation criteria

    Sex
    Female & Male
    Age
    18+ years
    Accepts healthy volunteers
    none
    • confirmed and active CLL requiring treatment
    • at least one previous treatment for CLL and having achieved a complete or partial remission/response but after a period of 6 or more months, shows evidence of disease progression
    • diagnosis of refractory CLL (failure to achieve a complete or partial remission/response or disease progression within 6 months of last anti-CLL treatment
    • abnormal/inadequate blood values, liver and kidney function
    Inclusion and exclusion criteria
    Inclusion criteria:
    • confirmed and active CLL requiring treatment
    • at least one previous treatment for CLL and having achieved a complete or partial remission/response but after a period of 6 or more months, shows evidence of disease progression
    • fully active at a minimum or fully capable of selfcare and up and about more than 50% of waking hours
    • age 18yrs or older
    • signed written informed consent
    Exclusion criteria:
    • diagnosis of refractory CLL (failure to achieve a complete or partial remission/response or disease progression within 6 months of last anti-CLL treatment
    • abnormal/inadequate blood values, liver and kidney function
    • certain heart problems, serious significant diseases, AIHA, other current cancers or within the last 5 years
    • active or chronic infections
    • use of drugs to suppress allergic or inflammatory responses (glucocorticoids)
    • CLL transformation
    • CLL central nervous system involvement
    • current participation in other clinical study
    • inability to comply with the protocol activities
    • lactating or pregnant women or female patients of child-bearing potential (or male patients with such partners) not willing to use adequate contraception

    Trial location(s)

    This study does not involve prospective enrollment of participants.

    Study documents

    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

    Refer to study documents

    Recruitment status
    No longer a GSK study
    Actual primary completion date
    2014-17-12
    Actual study completion date
    Not applicable

    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
    Participate in clinical trial
    Access to clinical trial data by researchers
    Visit website