A Phase II Study of Daily Alternating Thalidomide and Lenalidomide Therapy Plus Rituximab (THRiL) as Initial Treatment for Patients With CLL
This is an open label, phase II, single arm, and single institution study investigating
daily alternating therapy with IMiD™ compounds, thalidomide and lenalidomide, plus rituximab
in untreated CLL patients requiring treatment. In order to obtain correlative samples,
patients will receive a two week course of single agent thalidomide or lenalidomide before
beginning treatment with the combination regimen. Half of the patients (odd numbered
subjects) will start with a two week course of single agent thalidomide and the other half
of the patients (even numbered subjects) will start with a two week course of single agent
lenalidomide. This will allow the study of correlative samples of monotherapy with either
IMiD™ agent. In Cycle -1 half of the patients (odd numbered subjects) will receive
thalidomide 50mg PO daily on days 1-14, followed by no treatment days 15-28 and the other
half of the patients (even numbered subjects) will receive lenalidomide PO daily on days
1-14, followed by no treatment days 15-28. Starting cycle 1: Patients will receive
thalidomide 50 mg every other day (every odd day on days 1-28: Days 1, 3, 5, 7, 9, 11, 13,
15, 17, 19, 21, 23, 25 & 27 of a 28 day cycle) alternating with lenalidomide on alternate
every other day, dosed based upon current level with stepwise incremental dosing (every even
day on days 1-28: Days 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26 & 28 of a 28 day
cycle). The starting dose of lenalidomide will be based on calculated creatinine clearance
and the dose of lenalidomide may be escalated as tolerated to maximal dose of 25 mg (see
Section 5 for details). Rituximab 375 mg/m2 will be administered on days 1, 8, 15 and 22
starting with Cycle 1 and then again on the same weekly x 4 schedule every 6th cycle
thereafter (Cycles 7, 13, 19, etc).
Interventional
Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
number of patients who experience a response (complete or partial) to treatment
Response and progression will be evaluated in this study using the International Workshop on CLL (IWCLL) update of the 1996 NCI-Working Group criteria for CLL
estimation of 24 months to determine response rate for all subjects
No
Richard Furman, MD
Principal Investigator
Weill Medical College of Cornell University
United States: Food and Drug Administration
1002010897
NCT01125176
May 2012
May 2014
Name | Location |
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Weill Cornell Medical College | New York, New York 10021 |