Clinical efficacy of lenalidomide in patients with relapsed or refractory chronic lymphocytic leukemia: Results of a phase II study

Asher A Chanan Khan, Kena C. Miller, Laurie Musial, David Lawrence, Swaminathan Padmanabhan, Kenichi Takeshita, Carl W. Porter, David W. Goodrich, Zale P. Bernstein, Paul Wallace, David Spaner, Alice Mohr, Catriona Byrne, Francisco Hernandez-Ilizaliturri, Cynthia Chrystal, Petr Starostik, Myron S. Czuczman

Research output: Contribution to journalArticle

353 Citations (Scopus)

Abstract

Purpose: Patients with relapsed or refractory chronic lymphocytic leukemia (CLL) have profound immune defects and limited treatment options. Given the dramatic activity of lenalidomide in other B-cell malignancies and its pleotropic immunomodulatory effects, we conducted a phase II trial of this agent in CLL. Patients and Methods: Patients with relapsed or refractory B-cell CLL (B-CLL) were eligible if they required treatment as per the National Cancer Institute Working Group 1996 guidelines. Lenalidomide was administered orally at 25 mg on days 1 through 21 of a 28-day cycle. Response was assessed after each cycle. Patients were to continue treatment until disease progression, unacceptable toxicity, or complete remission. Rituximab was added to lenalidomide on disease progression. Results: Forty-five patients were enrolled, with a median age of 64 years. Sixty-four percent of the patients had Rai stage III or IV disease, and 51% were refractory to fludarabine. The overall response rate was 47%, with 9% of the patients attaining a complete remission. Fatigue, thrombocytopenia, and neutropenia were the most common adverse effects noted in 83%, 78%, and 78% of the patients, respectively. Conclusion: Lenalidomide is clinically active in patients with relapsed or refractory B-CLL. These findings are encouraging and warrant further investigation of this agent in the treatment of this disorder.

Original languageEnglish (US)
Pages (from-to)5343-5349
Number of pages7
JournalJournal of Clinical Oncology
Volume24
Issue number34
DOIs
StatePublished - Dec 1 2006
Externally publishedYes

Fingerprint

B-Cell Chronic Lymphocytic Leukemia
Disease Progression
B-Lymphocytes
lenalidomide
National Cancer Institute (U.S.)
Therapeutics
Neutropenia
Thrombocytopenia
Fatigue
Guidelines

ASJC Scopus subject areas

  • Cancer Research
  • Oncology
  • Medicine(all)

Cite this

Clinical efficacy of lenalidomide in patients with relapsed or refractory chronic lymphocytic leukemia : Results of a phase II study. / Chanan Khan, Asher A; Miller, Kena C.; Musial, Laurie; Lawrence, David; Padmanabhan, Swaminathan; Takeshita, Kenichi; Porter, Carl W.; Goodrich, David W.; Bernstein, Zale P.; Wallace, Paul; Spaner, David; Mohr, Alice; Byrne, Catriona; Hernandez-Ilizaliturri, Francisco; Chrystal, Cynthia; Starostik, Petr; Czuczman, Myron S.

In: Journal of Clinical Oncology, Vol. 24, No. 34, 01.12.2006, p. 5343-5349.

Research output: Contribution to journalArticle

Chanan Khan, AA, Miller, KC, Musial, L, Lawrence, D, Padmanabhan, S, Takeshita, K, Porter, CW, Goodrich, DW, Bernstein, ZP, Wallace, P, Spaner, D, Mohr, A, Byrne, C, Hernandez-Ilizaliturri, F, Chrystal, C, Starostik, P & Czuczman, MS 2006, 'Clinical efficacy of lenalidomide in patients with relapsed or refractory chronic lymphocytic leukemia: Results of a phase II study', Journal of Clinical Oncology, vol. 24, no. 34, pp. 5343-5349. https://doi.org/10.1200/JCO.2005.05.0401
Chanan Khan, Asher A ; Miller, Kena C. ; Musial, Laurie ; Lawrence, David ; Padmanabhan, Swaminathan ; Takeshita, Kenichi ; Porter, Carl W. ; Goodrich, David W. ; Bernstein, Zale P. ; Wallace, Paul ; Spaner, David ; Mohr, Alice ; Byrne, Catriona ; Hernandez-Ilizaliturri, Francisco ; Chrystal, Cynthia ; Starostik, Petr ; Czuczman, Myron S. / Clinical efficacy of lenalidomide in patients with relapsed or refractory chronic lymphocytic leukemia : Results of a phase II study. In: Journal of Clinical Oncology. 2006 ; Vol. 24, No. 34. pp. 5343-5349.
@article{fe9f9be9b41b4b38a1fab56d0ee212bd,
title = "Clinical efficacy of lenalidomide in patients with relapsed or refractory chronic lymphocytic leukemia: Results of a phase II study",
abstract = "Purpose: Patients with relapsed or refractory chronic lymphocytic leukemia (CLL) have profound immune defects and limited treatment options. Given the dramatic activity of lenalidomide in other B-cell malignancies and its pleotropic immunomodulatory effects, we conducted a phase II trial of this agent in CLL. Patients and Methods: Patients with relapsed or refractory B-cell CLL (B-CLL) were eligible if they required treatment as per the National Cancer Institute Working Group 1996 guidelines. Lenalidomide was administered orally at 25 mg on days 1 through 21 of a 28-day cycle. Response was assessed after each cycle. Patients were to continue treatment until disease progression, unacceptable toxicity, or complete remission. Rituximab was added to lenalidomide on disease progression. Results: Forty-five patients were enrolled, with a median age of 64 years. Sixty-four percent of the patients had Rai stage III or IV disease, and 51{\%} were refractory to fludarabine. The overall response rate was 47{\%}, with 9{\%} of the patients attaining a complete remission. Fatigue, thrombocytopenia, and neutropenia were the most common adverse effects noted in 83{\%}, 78{\%}, and 78{\%} of the patients, respectively. Conclusion: Lenalidomide is clinically active in patients with relapsed or refractory B-CLL. These findings are encouraging and warrant further investigation of this agent in the treatment of this disorder.",
author = "{Chanan Khan}, {Asher A} and Miller, {Kena C.} and Laurie Musial and David Lawrence and Swaminathan Padmanabhan and Kenichi Takeshita and Porter, {Carl W.} and Goodrich, {David W.} and Bernstein, {Zale P.} and Paul Wallace and David Spaner and Alice Mohr and Catriona Byrne and Francisco Hernandez-Ilizaliturri and Cynthia Chrystal and Petr Starostik and Czuczman, {Myron S.}",
year = "2006",
month = "12",
day = "1",
doi = "10.1200/JCO.2005.05.0401",
language = "English (US)",
volume = "24",
pages = "5343--5349",
journal = "Journal of Clinical Oncology",
issn = "0732-183X",
publisher = "American Society of Clinical Oncology",
number = "34",

}

TY - JOUR

T1 - Clinical efficacy of lenalidomide in patients with relapsed or refractory chronic lymphocytic leukemia

T2 - Results of a phase II study

AU - Chanan Khan, Asher A

AU - Miller, Kena C.

AU - Musial, Laurie

AU - Lawrence, David

AU - Padmanabhan, Swaminathan

AU - Takeshita, Kenichi

AU - Porter, Carl W.

AU - Goodrich, David W.

AU - Bernstein, Zale P.

AU - Wallace, Paul

AU - Spaner, David

AU - Mohr, Alice

AU - Byrne, Catriona

AU - Hernandez-Ilizaliturri, Francisco

AU - Chrystal, Cynthia

AU - Starostik, Petr

AU - Czuczman, Myron S.

PY - 2006/12/1

Y1 - 2006/12/1

N2 - Purpose: Patients with relapsed or refractory chronic lymphocytic leukemia (CLL) have profound immune defects and limited treatment options. Given the dramatic activity of lenalidomide in other B-cell malignancies and its pleotropic immunomodulatory effects, we conducted a phase II trial of this agent in CLL. Patients and Methods: Patients with relapsed or refractory B-cell CLL (B-CLL) were eligible if they required treatment as per the National Cancer Institute Working Group 1996 guidelines. Lenalidomide was administered orally at 25 mg on days 1 through 21 of a 28-day cycle. Response was assessed after each cycle. Patients were to continue treatment until disease progression, unacceptable toxicity, or complete remission. Rituximab was added to lenalidomide on disease progression. Results: Forty-five patients were enrolled, with a median age of 64 years. Sixty-four percent of the patients had Rai stage III or IV disease, and 51% were refractory to fludarabine. The overall response rate was 47%, with 9% of the patients attaining a complete remission. Fatigue, thrombocytopenia, and neutropenia were the most common adverse effects noted in 83%, 78%, and 78% of the patients, respectively. Conclusion: Lenalidomide is clinically active in patients with relapsed or refractory B-CLL. These findings are encouraging and warrant further investigation of this agent in the treatment of this disorder.

AB - Purpose: Patients with relapsed or refractory chronic lymphocytic leukemia (CLL) have profound immune defects and limited treatment options. Given the dramatic activity of lenalidomide in other B-cell malignancies and its pleotropic immunomodulatory effects, we conducted a phase II trial of this agent in CLL. Patients and Methods: Patients with relapsed or refractory B-cell CLL (B-CLL) were eligible if they required treatment as per the National Cancer Institute Working Group 1996 guidelines. Lenalidomide was administered orally at 25 mg on days 1 through 21 of a 28-day cycle. Response was assessed after each cycle. Patients were to continue treatment until disease progression, unacceptable toxicity, or complete remission. Rituximab was added to lenalidomide on disease progression. Results: Forty-five patients were enrolled, with a median age of 64 years. Sixty-four percent of the patients had Rai stage III or IV disease, and 51% were refractory to fludarabine. The overall response rate was 47%, with 9% of the patients attaining a complete remission. Fatigue, thrombocytopenia, and neutropenia were the most common adverse effects noted in 83%, 78%, and 78% of the patients, respectively. Conclusion: Lenalidomide is clinically active in patients with relapsed or refractory B-CLL. These findings are encouraging and warrant further investigation of this agent in the treatment of this disorder.

UR - http://www.scopus.com/inward/record.url?scp=33947243663&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=33947243663&partnerID=8YFLogxK

U2 - 10.1200/JCO.2005.05.0401

DO - 10.1200/JCO.2005.05.0401

M3 - Article

C2 - 17088571

AN - SCOPUS:33947243663

VL - 24

SP - 5343

EP - 5349

JO - Journal of Clinical Oncology

JF - Journal of Clinical Oncology

SN - 0732-183X

IS - 34

ER -