A Phase II Study of Ofatumumab in Combination With High-dose Methylprednisolone in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL)
The CLL Research Consortium (CRC) is conducting a phase II clinical trial of Ofatumumab in
combination with High-Dose Methylprednisolone (HDMP). Patients who have relapsed/refractory
CLL and require therapy as per iwCLL guidelines will be eligible. Subjects will receive a
treatment with ofatumumab and HDMP for three consecutive 4 week cycles. The primary endpoint
is to determine the complete response (CR) to therapy and the secondary endpoints will
assess the safety and tolerability of the regimen, the impact of the treatment on
progression free, treatment free, overall survival, and pharmacokinetics of ofatumumab.
Cycles 1-3 will be administered without scheduled interruption every 28 days for a total of
12 weeks of therapy. Patients will receive allopurinol for tumor-lysis prophylaxis and
antimicrobial prophylaxis. Blood glucose levels will be monitored immediately after HDMP
infusion by finger stick glucometry. Two months following completion of treatment a response
assessment will occur per iwCLL guidelines. The treatment will be administered as
outpatient, and each cycle will be four weeks in duration.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
IwCLL-WG defined complete remissions
2 years
No
Danelle F James, MD, MAS
Principal Investigator
University of California, San Diego
United States: Food and Drug Administration
100429
NCT01191190
August 2010
August 2012
Name | Location |
---|---|
University of California San Diego, Moores Cancer Center | La Jolla, California 92093 |
Danelle James, M.D. | La Jolla, California 92093 |