Phase II Study of Lenalidomide and Rituximab As Salvage Therapy for Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia

Badoux, Xavier C.; Keating, Michael J.; Wen, Sijin; Wierda, William G.; O'Brien, Susan M.; Faderl, Stefan; Sargent, Rachel; Burger, Jan A.; Ferrajoli, Alessandra

doi:10.1200/jco.2012.42.8623

Cited by 158Chronic Lymphocytic Leukemia ResearchLymphoma Diagnosis and TreatmentMultiple Myeloma Research and Treatments

Phase II Study of Lenalidomide and Rituximab As Salvage Therapy for Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia

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Badoux, Xavier C., Keating, Michael J., Wen, Sijin, Wierda, William G., O'Brien, Susan M., Faderl, Stefan, Sargent, Rachel, Burger, Jan A. +1 more·2013·Journal of Clinical Oncology

DOI 10.1200/jco.2012.42.8623PMC PMC4878047

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Abstract

Purpose: Lenalidomide is an immunomodulatory drug active as salvage therapy for chronic lymphocytic leukemia (CLL). We combined lenalidomide with rituximab to improve response rates in patients with relapsed or refractory CLL. Patients and Methods: Fifty-nine adult patients (age 42 to 82 years) with relapsed or refractory CLL were enrolled onto a phase II study of lenalidomide and rituximab. Patients had received prior fludarabine-based therapy or chemoimmunotherapy. Rituximab (375 mg/m 2 intravenously) was administered weekly during cycle one and on day 1 of cycles three to 12. Lenalidomide was started on day 9 of cycle one at 10 mg orally and administered daily continuously. Each cycle was 28 days. Rituximab was administered for 12 cycles; lenalidomide could continue indefinitely if patients benefitted clinically. Results: The overall response rate was 66%, including 12% complete responses and 12% nodular partial remissions. Time to treatment failure was 17.4 months. Median overall survival has not been reached; estimated survival at 36 months is 71%. The most common grade 3 or 4 toxicity was neutropenia (73% of patients). Fourteen patients (24%) experienced a grade 3 to 4 infection or febrile episode. There was one episode of grade 3 tumor lysis; one patient experienced renal failure during the first cycle of therapy, and one venous thromboembolic event occurred during the study. Conclusion: The combination of lenalidomide and rituximab is active in patients with recurrent CLL and warrants further investigation.

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Lenalidomide has safely been combined with other anti-CD20 antibodies, such as obinutuzumab, in the treatment of B cell lymphomas.
“Lenalidomide has also safely been combined with other anti-CD20 antibodies, such as obinutuzumab, in the treatment of B cell lymphomas (for example, R/R FL)80.”
From Cancer therapies based on targeted protein degradation — lessons learned with lenalidomide (2021) · cites this paper as [80]

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Authors: Badoux, X. C., Keating, M. J., Wen, S., Wierda, W. G., O'Brien, S. M., Faderl, S., Sargent, R., Burger, J. A., & Ferrajoli, A.
Affiliations: The University of Texas MD Anderson Cancer Center (US)
ORCID: Badoux, Xavier C.
Keating, Michael J.
Wen, Sijin
Wierda, William G.
O'Brien, Susan M.
Sargent, Rachel
Burger, Jan A.
Ferrajoli, Alessandra
Venue: Journal of Clinical Oncology
Publisher: American Society of Clinical Oncology (ASCO)
Published: 2013-02-10
Volume: 31
Issue: 5
Pages: 584-591
ISSN: 0732-183X (ISSN-L)
1527-7755
DOI: 10.1200/jco.2012.42.8623
PMC: PMC4878047
OpenAlex: W2136597718
Cited by: 158
References: 45
Citations by year: 2026: 1 · 2025: 2 · 2024: 5 · 2023: 2 · 2022: 3 · 2021: 5 · 2020: 8 · 2019: 4 · 2018: 6 · 2017: 17 · 2016: 16 · 2015: 27 · 2014: 33 · 2013: 28
FWCI: 13.44
Type: journal article
Language: en
Open access: green
www.ncbi.nlm.nih.gov
Locations: Journal of Clinical Oncology (publishedVersion)
PubMed Central (publishedVersion)
PubMed (publishedVersion)
IRIS Research product catalog (Sapienza University of Rome) (submittedVersion)
Funders: National Institutes of Health (4p01ca081534-16)
National Cancer Institute (P01-CA-081534)
Topics: Health Sciences › Medicine › Genetics › Chronic Lymphocytic Leukemia Research
Health Sciences › Medicine › Pathology and Forensic Medicine › Lymphoma Diagnosis and Treatment
Health Sciences › Medicine › Hematology › Multiple Myeloma Research and Treatments
Keywords: lenalidomide, rituximab, chronic lymphocytic leukemia, relapsed/refractory disease, salvage therapy, combination chemotherapy, immunomodulators, overall response rate, neutropenia, febrile infection, tumor lysis syndrome, venous thromboembolism
MeSH terms: Rituximab, Lenalidomide, Adult, Aged, Aged, 80 and over, Antineoplastic Combined Chemotherapy Protocols, Drug Administration Schedule, Female, Fever, Humans, Immunologic Factors, Infections, Male, Middle Aged, Neoplasm Staging, Recurrence, Thalidomide, Time Factors, Leukemia, Lymphocytic, Chronic, B-Cell, Salvage Therapy, Treatment Outcome, Disease-Free Survival, Drug Resistance, Neoplasm, Kaplan-Meier Estimate, Antibodies, Monoclonal, Murine-Derived

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Phase II Study of Lenalidomide and Rituximab As Salvage Therapy for Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia

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