Ofatumumab + Chlorambucil vs. Chlorambucil Monotherapy in Previously Untreated Patients With Chronic Lymphocytic Leukemia (COMPLEMENT 1)


Tracking Information

Start Date  ICMJEDecember 2008
Estimated Primary Completion DateMay 2013   (final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 15, 2009)
progression-free-survival (PFS) [ Time Frame: 259 events, 51.3 months ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ICMJE 
 (submitted: September 5, 2008)
median progression-free-survival (PFS) of ofatumumab added to chlorambucil therapy vs. chlorambucil therapy
Change HistoryComplete list of historical versions of study NCT00748189 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE 
 (submitted: January 15, 2009)
  • overall response rate [ Time Frame: 259 events, 51.3 months ] [ Designated as safety issue: No ]
  • overall survival [ Time Frame: 259 events, 51.3 months ] [ Designated as safety issue: No ]
  • Clinical benefit, safety, tolerability, changes in patient reported outcome measures and pharmacokinetics [ Time Frame: 259 events, 51.3 months ] [ Designated as safety issue: Yes ]
Original Secondary Outcome Measures ICMJE 
 (submitted: September 5, 2008)
clinical benefit, safety, tolerability, changes in patient reported outcome measures (PRO) and pharmacokinetics

Descriptive Information

Brief Title  ICMJEOfatumumab + Chlorambucil vs. Chlorambucil Monotherapy in Previously Untreated Patients With Chronic Lymphocytic Leukemia
Official Title  ICMJEA Phase III, Open Label, Randomized, Multicenter Trial of Ofatumumab Added to Chlorambucil Versus Chlorambucil Monotherapy in Previously Untreated Patients With Chronic Lymphocytic Leukemia
Brief Summary

The purpose of this study is to evaluate the safety and efficacy of ofatumumab added to chlorambucil in patients with untreated Chronic Lymphocytic Leukemia.

Detailed Description

Chlorambucil, is currently approved for treatment of frontline chronic lymphocytic leukemia, especially, but not limited to the ailing and elderly patient population. Several other more aggressive treatment options are available (e.g. fludarabine), however they are not suitable for all CLL patients, especially the ailing and elderly, due to greater toxicity. Ofatumumab is effective with low toxicity. The addition of ofatumumab to chlorambucil offers potentially a more effective therapy, with limited toxicity. The objective of this study is to evaluate progression-free survival (PFS), overall response and overall survival in subjects with previously untreated CLL with ofatumumab added to chlorambucil versus chlorambucil.

Study PhasePhase III
Study Type  ICMJEInterventional
Study Design  ICMJETreatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
Condition  ICMJEChronic Lymphocytic Leukemia
Intervention  ICMJE
  • Drug: ofatumumab (GSK1841157) infusion
    iv infusion; dose: cycle 1 300mg day 1 and 1000mg day 8, subsequent cycles: 1000mg at day 1 every 28 days;
    Other Names:
    • chlorambucil, tablets
    • ofatumumab (GSK1841157) infusion
  • Drug: chlorambucil, tablets
    2mg tablets, chlorambucil dose: 10mg/m2 PO at days 1-7 every 28 days; duration: minimum of 3 cycles until best response or maximum of 12 cycles
Study Arms / Comparison Groups
  • ofatumumab + chlorambucil: Experimental
    ofatumumab dose: cycle 1 300mg day 1 and 1000mg day 8, subsequent cycles: 1000mg at day 1 every 28 days; chlorambucil dose: 10mg/m2 PO at days 1-7 every 28 days; duration: minimum of 3 cycles until best response or maximum of 12 treatment cycles
    Interventions:
    • Drug: ofatumumab (GSK1841157) infusion
    • Drug: chlorambucil, tablets
  • chlorambucil: Active Comparator
    chlorambucil dose: 10mg/m2 PO at days 1-7 every 28 days; duration: minimum of 3 cycles until best response or maximum of 12 cycles
    Intervention: Drug: chlorambucil, tablets

Recruitment Information

Estimated Enrollment  ICMJE444
Estimated Completion DateMay 2018
Estimated Primary Completion DateMay 2013   (final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • confirmed CLL diagnosis and active CLL requiring treatment
  • considered inappropriate for fludarabine-based therapy
  • not been treated for CLL before
  • 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:

  • prior CLL therapy
  • abnormal/inadequate blood values, liver, and kidney function
  • certain heart problems, active or chronic infections, serious significant diseases, AIHA, other current cancer or within last 5 years
  • 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
GenderBoth
Ages18 Years and older
Accepts Healthy VolunteersNo
Contacts  ICMJE
Contact: US GSK Clinical Trials Call Center877-379-3718
Location Countries  ICMJEUnited States,   Belgium,   Czech Republic,   Germany,   Greece,   India,   Ireland,   Italy,   Netherlands,   Poland,   Russian Federation,   Spain,   Sweden,   United Kingdom

Administrative Information

NCT ID  ICMJENCT00748189
Responsible PartyStudy Director, GSK
Study ID Numbers  ICMJEOMB110911, EudraCT 2008-004932-19
Study Sponsor  ICMJEGlaxoSmithKline
Collaborators  ICMJE 
Investigators  ICMJE
Study Director:GSK Clinical TrialsGlaxoSmithKline
Information Provided ByGlaxoSmithKline