Phase II Study of Ofatumumab in Combination With High Dose Methylprednisolone Followed by Ofatumumab and Lenalidomide Consolidative Therapy for the Treatment of Relapsed or Refractory CLL/SLL The HiLOG Trial
This is a phase II, single institution, and non-randomized study of patients with relapsed
or refractory CLL/SLL, utilizing a two-stage trial design. The primary endpoint for this
trial is the combined complete and partial response rate at 3 months (after the end of cycle
3) to the protocol therapy. Investigators anticipate this trial will have a complete
response and partial response (CR+PR) rate of at least 55%.
A two-stage design is employed for this trial. The null/unacceptable CR+PR response rate is
≤35% while the anticipated true response rate to the protocol treatment is at least 55% for
each disease cohort. At the first stage, 25 patients will be accrued to the trial. If 9 or
fewer of these patients respond, then the trial will be terminated early and the response
rate to the protocol treatment will be deemed unacceptable (≤35%). Otherwise, if more than 9
patients respond during the first stage, an additional 31 patients will be enrolled to this
trial during stage 2 for a total of 56 patients. If 25 or fewer of these 56 patients respond
to the protocol treatment at the end of stage 2, no further investigation of the protocol
treatment is considered warranted. On the other hand, if more than 25 patients out of the 56
enrolled patients respond, the protocol treatment will be considered promising. If the true
response rate is ≤35%, the probability of ending the trial at stage 1 is 0.63. If, however,
the true response rate is at least 55%, then the probability of ending the trial at stage 1
is only 0.04. This two-stage design has an overall alpha level of 0.047 and a power of 0.90.
For the purpose of interim analysis at the end of stage 1, the objective response will be
measured by the end of 3 months (or end of cycle 3) from the start of the protocol treatment
prior to the initiation of the combination of ofatumumab with lenalidomide. The accrual will
not be suspended while waiting for the results of the interim analysis unless the observed
objective response rate among those patients whose objective response data are available is
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Number of Participants With Complete Response (CR)
The primary endpoint for this trial is the combined complete and partial response rate to the protocol therapy at 3 months, which is the end of Cycle 3.
Celeste Bello, M.D.
H. Lee Moffitt Cancer Center and Research Institute
United States: Food and Drug Administration
|H. Lee Moffitt Cancer Center and Research Institute||Tampa, Florida 33612|