Lenalidomide and rituximab for the initial treatment of chronic lymphocytic leukemia: Report of an ongoing study.

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BlankLenalidomide and rituximab for the initial treatment of chronic lymphocytic

leukemia: Report of an ongoing study.

Sub-category: Leukemia

Category: Leukemia, Myelodysplasia, and Transplantation

Meeting: 2010 ASCO Annual Meeting

Citation: J Clin Oncol 28:7s, 2010 (suppl; abstr 6583)

Abstract No: 6583

Author(s): D. F. , J. R. Brown, L. Werner, W. G. Wierda, K. R. Rai, J.

Gould, J. E. Castro, L. Rassenti, D. S. Neuberg, T. J. Kipps; Chronic

Lymphocytic Leukemia Research Consortium, University of California, San Diego

s Cancer Center, la Jolla, CA; Dana-Farber Cancer Institute, Boston, MA;

Department of Biostatistics and Computational Biology, Dana-Farber Cancer

Institute, Boston, MA; University of Texas M. D. Cancer Center,

Houston, TX; Long Island Jewish Medical Center, New hyde park, NY; University of

California, San Diego s Cancer Center, La Jolla, CA

Abstract:

Background: Lenalidomide (L) is an immunomodulatory agent and rituximab ® a

mAb with therapeutic activity in CLL. A phase II study was designed to evaluate

this immunotherapy combination in treatment-naïve CLL pts with an indication for

therapy. Methods: Pts were eligible if they had normal kidney function and no

recent thromboembolic events. Pts started L at 2.5 mg/day (D) and could escalate

to 5 mg/D on D8 to a maximum of 10 mg/D if tolerated. Pts received L 21/35 D for

cycle © 1, then for 21/28 D for C2-7. R 50 mg/m2 D29, 325 mg/m2 D31, 375 mg/m2

D33, C1, then 375 mg/m2 weekly x 4 for C2 and on D1 for C3-7. Pts received

allopurinol for tumor lysis prophylaxis. Results: 37 pts have been enrolled, 34

have demographic data and 30 evaluable for toxicity. Median age was 62 yrs (56

arm A, 73 arm . 17/34 pts were Rai stage III-IV (40% arm A, 63% arm . 16/31

pts had unmutated IgVH. FISH analysis revealed deletion of 17p (3 pts) and 11q

(3 pts). The most common grade III/IV adverse events (AE) were neutropenia (18

pts), anemia (5 pts), and thrombocytopenia (4 pts). There were no cases of

neutropenic fever, sepsis, or bleeding. Nonhematologic grade III/IV AEs included

infection (3 pts arm , rash (2 pts), and pulmonary embolus (PE) (1 pt per

arm). The protocol was amended to include aspirin prophylaxis. Most frequent AEs

(all grades) were the tumor flare reaction (TFR) (21/30), fatigue (19/30), and

transient elevation of liver transaminases (25/30). TFR occurred in 15/17 pts

(arm A) and 6/12 (arm . Only a fraction of pts experienced TFR following the

institution of R. Biochemical tumor lysis was observed in 2 pts without clinical

tumor lysis. There have been no deaths. Median dose was 10 mg (arm A) and 5 mg

(arm for pts that received > 3 cycles. 7 pts have been removed from study, 1

ineligible, 1 intolerance to R, 1 due to PCP, 1 with PE, 1 rash, and 1

thrombocytopenia. No pts have been removed for progressive disease. At interim

analysis the criteria for continuing accrual to a total of 40 pts in each

stratum were met with at least 2 clinical complete responses in each arm.

Conclusions: Early results of the ongoing study suggest that immunotherapy with

L and R is tolerable. TFR, a frequent AE did not usually occur following C1

possibly related to the use of R.