Cited by 657Chronic Lymphocytic Leukemia ResearchLymphoma Diagnosis and TreatmentMonoclonal and Polyclonal Antibodies Research

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Cytokine-Release Syndrome in Patients With B-Cell Chronic Lymphocytic Leukemia and High Lymphocyte Counts After Treatment With an Anti-CD20 Monoclonal Antibody (Rituximab, IDEC-C2B8)

Winkler, U., Jensen, M., Manzke, O., Schulz, H., Diehl, V., Engert, A.·1999·Blood

DOI 10.1182/blood.v94.7.2217.419k02_2217_2224

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Abstract

Eleven patients with relapsed fludarabine-resistant B-cell chronic lymphocytic leukemia (CLL) or leukemic variants of low-grade B-cell non-Hodgkin’s lymphoma (NHL) were treated with the chimeric monoclonal anti-CD20 antibody rituximab (IDEC-C2B8). Peripheral lymphocyte counts at baseline varied from 0.2 to 294.3 × 109/L. During the first rituximab infusion, patients with lymphocyte counts exceeding 50.0 × 109/L experienced a severe cytokine-release syndrome. Ninety minutes after onset of the infusion, serum levels of tumor necrosis factor- (TNF-) and interleukin-6 (IL-6) peaked in all patients. Elevated cytokine levels during treatment were associated with clinical symptoms, including fever, chills, nausea, vomiting, hypotension, and dyspnea. Lymphocyte and platelet counts dropped to 50% to 75% of baseline values within 12 hours after the onset of the infusion. Simultaneously, there was a 5-fold to 10-fold increase of liver enzymes, d-dimers, and lactate dehydrogenase (LDH), as well as a prolongation of the prothrombin time. Frequency and severity of first-dose adverse events were dependent on the number of circulating tumor cells at baseline: patients with lymphocyte counts greater than 50.0 × 109/L experienced significantly more adverse events of National Cancer Institute (NCI) grade III/IV toxicity than patients with less than 50.0 × 109/L peripheral tumor cells (P= .0017). Due to massive side effects in the first patient treated with 375 mg/m2 in 1 day, a fractionated dosing schedule was used in all subsequent patients with application of 50 mg rituximab on day 1, 150 mg on day 2, and the rest of the 375 mg/m2 dose on day 3. While the patient with the leukemic variant of the mantle-cell NHL achieved a complete remission (9 months+) after treatment with 4 × 375 mg/m2 rituximab, efficacy in patients with relapsed fludarabine-resistant B-CLL was poor: 1 partial remission, 7 cases of stable disease, and 1 progressive disease were observed in 9 evaluable patients with CLL. On the basis of these data, different infusion schedules and/or combination regimens with chemotherapeutic drugs to reduce tumor burden before treatment with rituximab will have to be evaluated.

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Authors: Winkler, U., Jensen, M., Manzke, O., Schulz, H., Diehl, V., & Engert, A.
Affiliations: University of Cologne (DE)
ORCID: Engert, A.
Venue: Blood
Publisher: American Society of Hematology
Published: 1999-10-01
Volume: 94
Issue: 7
Pages: 2217-2224
ISSN: 0006-4971 (ISSN-L)
1528-0020
DOI: 10.1182/blood.v94.7.2217.419k02_2217_2224
OpenAlex: W1685882185
Cited by: 657
References: 23
Citations by year: 2026: 6 · 2025: 14 · 2024: 21 · 2023: 19 · 2022: 26 · 2021: 28 · 2020: 35 · 2019: 27 · 2018: 17 · 2017: 30 · 2016: 15 · 2015: 16 · 2014: 21 · 2013: 21 · 2012: 16
FWCI: 17.59
Type: journal article
Language: en
Open access: closed
Locations: Blood (publishedVersion)
PubMed (publishedVersion)
Topics: Health Sciences › Medicine › Hematology › Chronic Lymphocytic Leukemia Research
Health Sciences › Medicine › Pathology and Forensic Medicine › Lymphoma Diagnosis and Treatment
Life Sciences › Immunology and Microbiology › Immunology › Monoclonal and Polyclonal Antibodies Research
Keywords: cytokine release syndrome, rituximab, anti-CD20 monoclonal antibody, chronic lymphocytic leukemia, relapsed CLL, non-Hodgkin lymphoma, TNF-α, interleukin-6, infusion toxicity, dose fractionation, circulating tumor cells, mantle cell lymphoma, fludarabine resistance
MeSH terms: Rituximab, Adult, Aged, Antibodies, Monoclonal, Antineoplastic Agents, Female, Humans, Liver Function Tests, Male, Middle Aged, Neoplasm Staging, Platelet Count, Syndrome, Tumor Necrosis Factor-alpha, Leukemia, Lymphocytic, Chronic, B-Cell, Interleukin-6, Cytokines, Lymphocyte Count, Antigens, CD20, Lymphoma, Mantle-Cell, Antibodies, Monoclonal, Murine-Derived

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Cytokine-Release Syndrome in Patients With B-Cell Chronic Lymphocytic Leukemia and High Lymphocyte Counts After Treatment With an Anti-CD20 Monoclonal Antibody (Rituximab, IDEC-C2B8)

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