Table 1

Published trials with lenalidomide in CLL

ReferenceStatus*PhaseNo. of patientsAge, median (range)No. of prior therapies, median (range)del17p, %†Scheme‡LenalidomideResponse, %||PFS, moToxicity, %#
Dose, mg/d§SchemeORRCRPR, incl nPRGrade 3-4 neutropeniaTLSTFR
Upfront                 
 Badoux et al24 ** Completed 2 60 71 (66-85)  10 len mono 5→25 Continuous 65 15 50 NR 83 0 52 
 Chen et al26 †† Completed 2 25 60 (33-78)  32‡‡ len mono 2.5→25 21 of 28 d 56 0 56 NR 72 4 88 
 Chen et al27 †† Completed 2 25 60 (33-78)  32‡‡ len mono 2.5→25 21 of 28 d 72 12 60 NR 76 4 88 
 James et al28  Completed 2 40 56 (45-64)  10 len+R 2.5→10 21 of 28 d 95 20 75 19 53 UN 83 
   29 70 (65-80)  7    79 10 69 20 66 UN 66 
 Brown et al29  Terminated 1 9 59 (37-66)  None len+FR 2.5→25 21 of 28 d 56 11 45 UN Study halted because of grade 3-4 hematologic toxicity and TFS 
 Flinn et al30  Open 1/2 51 62 (44-82)  12a len+FR 2.5→5 21 of 28 d 43 11 41 NR 47 UN UN 
 Egle et al31 b Completed 1/2 45 66 (43-79)  UNc len+FR 2.5→25 21 of 28 d 87 49 38 NR 88 0 UN 
 Egle et al32 b Completed 1/2 40 67 (43-79)  UNc len+FR + len+R maint. 2.5→25 21 of 28 d 96 67 29 46 72 0 UN 
 Strati et al25  Open 2 25 68 (44-79)  12 len+R + len maint. 10 Continuous 85 10 75 NR 36 UN 29 
Relapsed or refractory                 
 Chanan-Khan et al33  Completed 2 45 64 (42-75) 3 (1-10) 13 len mono 25 21 of 28 d 47 9 38 NR 70 4 58 
 Ferrajoli et al34  Completed 2 44 64 (49-86) 5 (1-15) 18 len mono 10→25 Continuous 32 7 25 NR 41d 0 12e 
 Wendtner et al35  Completed 1 52 65 (37-80) 4 (1-14) 17 len mono 2.5→20 Continuous 11.5 0 11.5 6 65 4 44 
 Buhler et al36  Open 2 104 64 (32-81) >1 25e len mono 5→25 Continuous 44 UN UN 11 UN UN UN 
 Ferrajoli et al37  Open 2 36 62 (34-82) 2 (1-8) 26 len+O 10 Continuous 65 15 50 NR 44 UN 24 
 Costa et al38  Completed 2 17 65 (51-80) 2 (1-4) 25 len+O 10 21 of 28 d 43 UN UN NR 79 UN 57 
 Sylvan et al39  Completed 1 12 71 (65-79) 4 (1-6) 42 len+A 2.5 or 5 Continuous 42 0 42 5 75 0 33 
 Badoux et al40  Open 2 59 62 (42-82) 2 (1-9) 25 len+R 10 Continuous 66 12 54 17.4 73 1.7 27 
Maintenance                 
 Shanafelt et al41  Open 2 34 65 (44-78) After PCR 2.3 len maint. 5→10 Continuous Improved quality of response in 8 patients (24%) NR 49 N/A N/A 
ReferenceStatus*PhaseNo. of patientsAge, median (range)No. of prior therapies, median (range)del17p, %†Scheme‡LenalidomideResponse, %||PFS, moToxicity, %#
Dose, mg/d§SchemeORRCRPR, incl nPRGrade 3-4 neutropeniaTLSTFR
Upfront                 
 Badoux et al24 ** Completed 2 60 71 (66-85)  10 len mono 5→25 Continuous 65 15 50 NR 83 0 52 
 Chen et al26 †† Completed 2 25 60 (33-78)  32‡‡ len mono 2.5→25 21 of 28 d 56 0 56 NR 72 4 88 
 Chen et al27 †† Completed 2 25 60 (33-78)  32‡‡ len mono 2.5→25 21 of 28 d 72 12 60 NR 76 4 88 
 James et al28  Completed 2 40 56 (45-64)  10 len+R 2.5→10 21 of 28 d 95 20 75 19 53 UN 83 
   29 70 (65-80)  7    79 10 69 20 66 UN 66 
 Brown et al29  Terminated 1 9 59 (37-66)  None len+FR 2.5→25 21 of 28 d 56 11 45 UN Study halted because of grade 3-4 hematologic toxicity and TFS 
 Flinn et al30  Open 1/2 51 62 (44-82)  12a len+FR 2.5→5 21 of 28 d 43 11 41 NR 47 UN UN 
 Egle et al31 b Completed 1/2 45 66 (43-79)  UNc len+FR 2.5→25 21 of 28 d 87 49 38 NR 88 0 UN 
 Egle et al32 b Completed 1/2 40 67 (43-79)  UNc len+FR + len+R maint. 2.5→25 21 of 28 d 96 67 29 46 72 0 UN 
 Strati et al25  Open 2 25 68 (44-79)  12 len+R + len maint. 10 Continuous 85 10 75 NR 36 UN 29 
Relapsed or refractory                 
 Chanan-Khan et al33  Completed 2 45 64 (42-75) 3 (1-10) 13 len mono 25 21 of 28 d 47 9 38 NR 70 4 58 
 Ferrajoli et al34  Completed 2 44 64 (49-86) 5 (1-15) 18 len mono 10→25 Continuous 32 7 25 NR 41d 0 12e 
 Wendtner et al35  Completed 1 52 65 (37-80) 4 (1-14) 17 len mono 2.5→20 Continuous 11.5 0 11.5 6 65 4 44 
 Buhler et al36  Open 2 104 64 (32-81) >1 25e len mono 5→25 Continuous 44 UN UN 11 UN UN UN 
 Ferrajoli et al37  Open 2 36 62 (34-82) 2 (1-8) 26 len+O 10 Continuous 65 15 50 NR 44 UN 24 
 Costa et al38  Completed 2 17 65 (51-80) 2 (1-4) 25 len+O 10 21 of 28 d 43 UN UN NR 79 UN 57 
 Sylvan et al39  Completed 1 12 71 (65-79) 4 (1-6) 42 len+A 2.5 or 5 Continuous 42 0 42 5 75 0 33 
 Badoux et al40  Open 2 59 62 (42-82) 2 (1-9) 25 len+R 10 Continuous 66 12 54 17.4 73 1.7 27 
Maintenance                 
 Shanafelt et al41  Open 2 34 65 (44-78) After PCR 2.3 len maint. 5→10 Continuous Improved quality of response in 8 patients (24%) NR 49 N/A N/A 
*

As registered in clinicaltrials.gov; June 2014.

†

UN, unknown/not reported.

‡

A, alemtuzumab; C, cyclophosphamide; F, fludarabine; len, lenalidomide; maint, maintenance; mono, monotherapy; MPS, methylprednisolone; O, ofatumumab; P, pentostatin; R, rituximab.

§

In most studies, dose escalation of lenalidomide was applied; doses before and after the arrow represent the minimum and maximum dose of lenalidomide per protocol. Of note, the highest dose level was not reached in all studies.

||

CR, complete remission; nPR, nodular partial remission; ORR, overall response rate; PR, partial remission.

NR, median PFS not reached; PFS, progression-free survival; UN, unknown/not reported.

#

N/A, not applicable; TFR, tumor flare reaction; TLS, tumor lysis syndrome.

**

An update on long-term outcome of these patients was published by Strati et al.25 

††

Two reports presenting results of 1 trial at different time points (at median follow-up of 20.7 and 47 mo, respectively).

‡‡

Including patients with del11q.

a

Including patients with del11q.

b

Two reports presenting results of 1 trial at different time points.

c

At least 1 molecular high risk feature (by CD38 expression, fluorescence in situ hybridization analysis, mutation status analysis) was present in 64% of patients.

d

Toxicity in percentage of cycles (as opposed to percentage of patients).

e

A TP53 mutation was found in 36/96 (38%) of the patients in this study; of these 20 patients did not have del17p.

View Large
This Feature Is Available To Subscribers Only

or Create an Account

Close Modal
Close Modal