Ofatumumab Added to Dexamethasone in Subjects With Relapsed or Refractory Chronic Lymphocytic Leukemia
This is an open-label, multi-center, non-randomized, phase II study to evaluate the safety
and efficacy of ofatumumab added to dexamethasone in subjects with relapsed or refractory
chronic lymphocytic leukemia.
The treatment will be given for a minimum of 3 cycles, until the best response, or up to a
maximum of 6 cycles. After completion of the treatment phase in all patients, survival and
disease status assessments will be performed in 1 month post treatment, and then every 2
months for 3 years. The patient will be followed-up in the study for 3 years if there is no
Dose and schedule Cycle 1: Ofatumumab: 300 mg as an i.v. infusion on day 1 of the cycle
Ofatumumab: 2000 mg as an i.v. infusion on days 8, 15, 22; Dexamethasone: 40 mg/day p.o.,
days 1-4 and 15-18; Cycles 2 to 6 (cycles every 28 days): Ofatumumab: 1000 mg i.v. infusion
on day 1, 8, 15 and 22 of the cycle; Dexamethasone: 40 mg/day p.o., days 1-4 and 15-18.
Response will be assessed according to the IWCLL guidelines. The investigator assessment of
response and progression will be considered primary for all endpoints described in the
Safety of the treatment will be evaluated by: adverse events, laboratory tests, vital signs,
electrocardiogram and performance status.
Overall response rate (CR, CRi, PR rates)
Toxicity, tolerability, adverse events (these events will be assessed by investigator and by
the independent reviewers at the key time-points) Overall survival Progression-free survival
Time to response and duration of response Time to progression and time to next therapy
Exploratory molecular genetic, immunophenotypic, cytogenetic and pharmacologic markers
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Overall response rate (complete remission - CR, CRi; partial remission - PR)
The response (CR, CRi, PR rates) will be assessed at the end of therapy of every patient according to international guideline.
Up to Week 24
Jiří Mayer, Prof., M.D.
University Hospital Brno, Department of Internal Medicine - Hematology and Oncology
Czech Republic: State Institute for Drug Control
O-DEX-1, OFA 113815