A Phase I/II Clinical Trial of Lenalidomide in Combination With AT-101 for the Treatment of Relapsed or Refactory B-Cell Chronic Lymphocytic Leukemia (B-CLL)
This is an open-label, single institute Phase I/II non-randomized study. Patients with
relapsed or refractory CLL (received at least one prior therapy for B-CLL) will be eligible
for this study. Phase I: Patients will receive a fixed dose of AT-101 (40mg orally twice
daily x 3 days) while the dose of lenalidomide will be escalated in subsequent patient
cohorts. Starting dose of lenalidomide will be 5mg/day and the dose will increase by 5mg/day
to a maximum of 20mg/day in 4 separate cohorts. Each patient cohort must have at least 3
patients. Dose limiting toxicity will be determined during the first combination
(Lenalidomide + AT-101) cycle (cycle 2). Both drugs will be given on a 21-day schedule where
lenalidomide will be given on day 1 through day 21 of all cycles and AT-101 will be given on
days 1, 2 and 3 or cycles 2-12. This 21 day period will constitute a treatment cycle.
Patients will receive a maximum of 12 cycles of treatment and during the first cycle, only
single agent lenalidomide will be given. AT-101 will be added starting day 1 of cycle #2.
Patients will be evaluated for response every two cycles and those patients who show some
degree of response (defined as CR, PR, or SD) will continue treatment. Those patients who
show disease progression at any time will be taken off the clinical protocol. Since the
study will be investigating the maximum tolerated dose (MTD) of lenalidomide in combination
with fixed dose of AT-101, the MTD will be established during the 2nd cycle of treatment
instead of the first (this cycle will actually be the first cycle of the combination
regimen). MTD will be determined during day 1 through day 21 of cycle 2. Once the MTD of the
combination is established, Phase II section of the study will then be open to accrual. All
patients in the phase I portion of the study must have completed at least 2 cycles of the
combination therapy prior to opening the Phase II portion of the study for accrual. This
will allow better characterization of the toxicity profile of the combination.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Determine the maximum tolerated dose of lenalidomide in combination with AT-101
3 months
Yes
Asher Chanan-Khan, MD
Principal Investigator
Roswell Park Cancer Institute
United States: Food and Drug Administration
RPCI I 101307
NCT01003769
December 2009
Name | Location |
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Roswell Park Cancer Institute | Buffalo, New York 14263 |