Ofatumumab Added to Fludarabine-Cyclophosphamide vs. Fludarabine-Cyclophosphamide Combination in Relapsed Subjects With Chronic Lymphocytic Leukemia


Tracking Information

Start Date  ICMJEMarch 2009
Estimated Primary Completion DateAugust 2011   (final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE 
 (submitted: April 2, 2009)		Progression-free-survival [ Time Frame: 3 years ] [ Designated as safety issue: No ]
Original Primary Outcome Measures  ICMJE 
 (submitted: January 15, 2009)		Progression-free-survival [ Time Frame: 234 events, 39.1 months ] [ Designated as safety issue: No ]
Change HistoryComplete list of historical versions of study NCT00824265 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE 
 (submitted: April 2, 2009)		Clinical benefit, safety, tolerability, changes in patient reported outcome measures and pharmacokinetics. [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
Original Secondary Outcome Measures  ICMJE 
 (submitted: January 15, 2009)		Clinical benefit, safety, tolerability, changes in patient reported outcome measures and pharmacokinetics. [ Time Frame: 234 events, 39.1 months ] [ Designated as safety issue: Yes ]

Descriptive Information

Brief Title  ICMJEOfatumumab Added to Fludarabine-Cyclophosphamide vs. Fludarabine-Cyclophosphamide Combination in Relapsed Subjects With Chronic Lymphocytic Leukemia
Official Title  ICMJEA Phase III, Open Label, Randomized Trial of Ofatumumab Added to Fludarabine-Cyclophosphamide vs. Fludarabine-Cyclophosphamide Combination in Subjects With Relapsed Chronic Lymphocytic Leukemia
Brief Summary

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.

Detailed Description

Fludarabine is currently approved for treatment of relapsed Chronic Lymphocytic Leukemia. Studies have shown that drugs in combination with fludarabine have shown more effectiveness than fludarabine alone. The addition of ofatumumab to fludarabine-cyclophosphamide combination offers potentially a more effective therapy, without additional toxicity.

The objective of this study is to determine the effect of ofatumumab added to fludarabine and cyclophosphamide in patients with Chronic Lymphocytic Leukemia who have responded previously to therapy but later develop progressive disease and require additional therapy.

Study PhasePhase III
Study Type  ICMJEInterventional
Study Design  ICMJETreatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
Condition  ICMJEChronic Lymphocytic Leukemia
Intervention  ICMJE
  • Drug: OFC Infusion
    Ofatumumab Cycle 1-Day 1 300mg, Cycle 1-Day 8 1000mg, then Cycles 2-6 Day 1 1000mg every 28 days, Fludarabine 25mg/m2 Days 1-3 every 28 days for 6 cycles, Cyclophosphamide 250 mg/m2 Days 1-3 every 28 days for 6 cycles
  • Drug: FC infusion
    Fludarabine 25mg/m2 Days 1-3 every 28 days for 6 cycles, Cyclophosphamide 250mg/m2 Days 1-3 every 28 days for 6 cycles
Study Arms / Comparison Groups
  • Fludarabine, Cyclophosphamide: Active Comparator
    Intervention: Drug: FC infusion
  • Ofatumumab, Fludarabine, Cyclophosphamide: Experimental
    Intervention: Drug: OFC Infusion

Recruitment Information

Estimated Enrollment  ICMJE352
Estimated Completion DateOctober 2015
Estimated Primary Completion DateAugust 2011   (final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 patinets 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,   Canada,   Germany,   Greece,   India,   Italy,   Mexico,   Netherlands,   Poland,   Russian Federation,   Spain,   Taiwan,   Thailand,   United Kingdom

Administrative Information

NCT ID  ICMJENCT00824265
Responsible PartyStudy Director, GSK
Study ID Numbers  ICMJE110913
Study Sponsor  ICMJEGlaxoSmithKline
Collaborators  ICMJE 
Investigators  ICMJE
Study Director:GSK Clinical TrialsGlaxoSmithKline
Information Provided ByGlaxoSmithKline