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Cited by 131Lymphoma Diagnosis and TreatmentChronic Lymphocytic Leukemia ResearchViral-associated cancers and disorders

A phase 2, multicentre, single-arm, open-label study to evaluate the safety and efficacy of single-agent lenalidomide (Revlimid®) in subjects with relapsed or refractory peripheral T-cell non-Hodgkin lymphoma: The EXPECT trial

Morschhauser, Franck, Fitoussi, Olivier, Haioun, Corinne, Thieblemont, Catherine, Quach, Hang, Delarue, Richard, Glaisner, Sylvie, Gabarre, Jean +4 more·2013·European Journal of Cancer
DOI 10.1016/j.ejca.2013.04.029
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Abstract

Background This multicentre, single-arm, open-label phase 2 trial investigated the efficacy and safety of lenalidomide monotherapy in patients with relapsed/refractory peripheral T-cell lymphoma (PTCL).Methods Patients received oral lenalidomide 25mg once daily on days 1-21 of each 28-day cycle for a maximum of 24 months, until disease progression or development of unacceptable adverse events (AEs). The primary end-point was efficacy; safety was evaluated as a secondary end-point. This study was registered with ClinicalTrials.gov, number NCT00655668.Findings A total of 54 patients with PTCL were treated. The overall response rate was 22% (12 of 54), including complete response (CR) or unconfirmed CR (CRu) in 11% of patients; 31% of patients with angioimmunoblastic T-cell lymphoma (AITL) responded (CR/CRu in 15% of patients). The median progression-free survival and median response duration were 2.5 and 3.6 months, respectively, in the intent-to-treat population, and 4.6 and 3.5 months, respectively, in patients with AITL. Thrombocytopenia and neutropenia were the most common grade 3 or 4 haematological AEs, in 11 (20%) and 8 (15%) patients, respectively. Overall, 19 patients (35%) experienced at least 1AE leading to study dose interruption or reduction (commonly neutropenia or thrombocytopenia). Serious AEs were observed in 54% of patients and 12 patients died during the study; lymphoma progression (n=6); and acute respiratory distress syndrome, dyspnea, lung infiltration, neutropenic sepsis, pneumonia and cerebral ischaemia (n=1 each).Interpretation Lenalidomide exhibited single-agent activity in heavily pretreated patients with PTCL, particularly in patients with AITL. Future development is warranted in specific histologies, such as AITL, and in combination with chemotherapy or other agents considered active in PTCL.Funding Celgene Corporation.

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  • In early phase studies, single-agent lenalidomide typically induced responses in about 30% (ORRs of 22-42%) of patients with R/R peripheral T cell lymphomas, mycosis fungoides or Sézary syndrome.

    “In early phase studies, single-agent lenalidomide typically induced responses in ~30% (ORRs of 22–42%) of patients with R/R peripheral T cell lymphomas90–92, mycosis fungoides or Sézary syndrome93.”

    From Cancer therapies based on targeted protein degradation — lessons learned with lenalidomide (2021) · cites this paper as [92]

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Authors
Morschhauser, F., Fitoussi, O., Haioun, C., Thieblemont, C., Quach, H., Delarue, R., Glaisner, S., Gabarre, J., Bosly, A., Lister, J., Li, J., & Coiffier, B.
Affiliations
  • Hôpital Claude Huriez (FR)
  • Polyclinique Bordeaux Nord Aquitaine (FR)
  • St Vincent's Hospital Melbourne (AU)
  • Hôpital Necker-Enfants Malades (FR)
  • Hôpital René Huguenin (FR)
  • Pitié-Salpêtrière Hospital (FR)
  • CHU Dinant Godinne UCL Namur (BE)
  • Western Pennsylvania Hospital (US)
  • Celgene (United States) (US)
ORCID
Venue
European Journal of Cancer
Publisher
Elsevier BV
Published
2013-09
Volume
49
Issue
13
Pages
2869-2876
ISSN
0959-8049 (ISSN-L)
DOI
10.1016/j.ejca.2013.04.029
OpenAlex
W1991998373
Cited by
131
References
33
Citations by year
2026: 4 · 2025: 12 · 2024: 6 · 2023: 9 · 2022: 8 · 2021: 18 · 2020: 7 · 2019: 12 · 2018: 12 · 2017: 13 · 2016: 13 · 2015: 7 · 2014: 5 · 2013: 5
FWCI
7.48
Type
journal article
Language
en
Open access
closed
Licence
www.elsevier.com/tdm/userlicense/1.0/ (tdm)
Locations
  • European Journal of Cancer (publishedVersion)
  • PubMed (publishedVersion)
  • Digital Access to Libraries (submittedVersion)
Funders
Celgene Corporation
Topics
  • Health Sciences › Medicine › Pathology and Forensic Medicine › Lymphoma Diagnosis and Treatment
  • Health Sciences › Medicine › Genetics › Chronic Lymphocytic Leukemia Research
  • Health Sciences › Medicine › Oncology › Viral-associated cancers and disorders
Keywords
lenalidomide, peripheral T-cell lymphoma, relapsed/refractory lymphoma, angioimmunoblastic T-cell lymphoma, monotherapy, overall response rate, progression-free survival, neutropenia, thrombocytopenia, adverse events
MeSH terms
Lenalidomide, Administration, Oral, Adult, Aged, Aged, 80 and over, Drug Administration Schedule, Europe, Female, Humans, Immunologic Factors, Male, Middle Aged, Thalidomide, Time Factors, Lymphoma, T-Cell, Peripheral, Treatment Outcome, Disease Progression, Disease-Free Survival, Angiogenesis Inhibitors, Kaplan-Meier Estimate, Intention to Treat Analysis, Early Termination of Clinical Trials

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