Multicenter Phase II Study of Lenalidomide in Relapsed or Recurrent Adult T-Cell Leukemia/Lymphoma: ATLL-002
Abstract
Purpose: Few treatment options exist for adult T-cell leukemia/lymphoma (ATL), and the prognosis for this disease is poor. A phase I study of lenalidomide demonstrated preliminary antitumor activity in patients with relapsed ATL. The current phase II study evaluated the efficacy and safety of lenalidomide monotherapy in patients with relapsed or recurrent ATL. Patients and Methods: Patients 20 years of age or older with acute, lymphoma, or unfavorable chronic subtype ATL, who had received one or more prior anti-ATL systemic chemotherapy and achieved stable disease or better on their last anti-ATL therapy with subsequent relapse or recurrence, were eligible. Patients received oral lenalidomide 25 mg/d continuously until disease progression or unacceptable toxicity. The primary end point was overall response rate; secondary end points included safety, tumor control rate (stable disease or better), time to response, duration of response, time to progression, progression-free survival, and overall survival. Results: Objective responses were noted in 11 of 26 patients (overall response rate, 42%; 95% CI, 23% to 63%), including four complete responses and one unconfirmed complete response. The tumor control rate was 73%. The median time to response and duration of response were 1.9 months and not estimable, respectively, and the median time to progression was 3.8 months. The median progression-free survival and overall survival were 3.8 and 20.3 months, respectively. The most frequent grade ≥ 3 adverse events were neutropenia (65%), leukopenia (38%), lymphopenia (38%), and thrombocytopenia (23%), which were all manageable and reversible. Conclusion: Lenalidomide demonstrated clinically meaningful antitumor activity and an acceptable toxicity profile in patients with relapsed or recurrent aggressive ATL, hinting at its potential to become a treatment option. Further investigations of lenalidomide in ATL and other mature T-cell neoplasms are warranted.
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Lenalidomide is approved in Japan for the treatment of relapsed and refractory (R/R) ATL with improved ORR.
“It is approved in Japan for the treatment of relapsed and refractory (R/R) ATL with improved ORR [209].”
From Current State of Therapeutics for HTLV-1 (2024) · cites this paper as [209]
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 [93]
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- Authors
- Ishida, T., Fujiwara, H., Nosaka, K., Taira, N., Abe, Y., Imaizumi, Y., Moriuchi, Y., Jo, T., Ishizawa, K., Tobinai, K., Tsukasaki, K., Ito, S., Yoshimitsu, M., Otsuka, M., Ogura, M., Midorikawa, S., Ruiz, W., & Ohtsu, T.
- Affiliations
- Nagoya City University (JP)
- ORCID
- Venue
- Journal of Clinical Oncology
- Published
- 2016-12-01
- Volume
- 34
- Issue
- 34
- Pages
- 4086-4093
- ISSN
- 0732-183X (ISSN-L)
- 1527-7755
- OpenAlex
- W2519997684
- Cited by
- 152
- References
- 44
- Citations by year
- 2026: 7 · 2025: 16 · 2024: 9 · 2023: 13 · 2022: 13 · 2021: 24 · 2020: 21 · 2019: 16 · 2018: 18 · 2017: 15
- FWCI
- 9.88
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- Journal of Clinical Oncology (publishedVersion)
- PubMed (publishedVersion)
- Funders
- Japan Society for the Promotion of Science (16H04713, 15K09506)
- Topics
- Life Sciences › Immunology and Microbiology › Immunology › T-cell and Retrovirus Studies
- Health Sciences › Medicine › Oncology › Viral-associated cancers and disorders
- Health Sciences › Medicine › Genetics › Chronic Lymphocytic Leukemia Research
- Keywords
- lenalidomide, adult T-cell leukemia/lymphoma, monotherapy, overall response rate, progression-free survival, neutropenia, adverse events, T-cell neoplasms
- MeSH terms
- Lenalidomide, Administration, Oral, Aged, Aged, 80 and over, Female, Humans, Male, Middle Aged, Prognosis, Recurrence, Remission Induction, Thalidomide, Leukemia-Lymphoma, Adult T-Cell, Survival Rate, Treatment Outcome, Disease Progression, Angiogenesis Inhibitors, Endpoint Determination
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