The following article features coverage from the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting. Click here to read more of Hematology Advisor‘s conference coverage.

The combination of romidepsin and lenalidomide is feasible and effective as initial therapy for patients with peripheral T-cell lymphoma (PTCL) who are not candidates for cytotoxic chemotherapy, according to research presented at the ASCO21 Virtual Scientific Program.

The study included patients with untreated PTCL who were older than 60 years or were not candidates for chemotherapy based on their Cumulative Illness Rating Scale score. Participants began treatment with romidepsin 10 mg/m2 IV on days 1, 8, and 15, and lenalidomide 25 mg PO on days 1 to 21 of a 28-day cycle for up to 1 year.

The primary endpoint was objective response rate (ORR) according to the Cheson criteria. Secondary endpoints included safety, progression-free survival (PFS), overall survival (OS), duration of response (DOR), and delay to chemotherapy.

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A total of 29 patients were enrolled at 3 US centers. A total of 16 patients (55%) had angioimmunoblastic T-cell lymphoma (AITL); 11 patients (38%) had PTCL not otherwise specified (PTCL-NOS); 1 had adult T-cell lymphoma/leukemia (ATLL); and 1 had enteropathy-associated T-cell lymphoma (EATCL). Participants’ median age was 75 years (range, 49-84) with a 1:1 sex ratio, and 19 patients (66%) had stage III/IV disease.

The study authors found that the treatment was well tolerated. Neutropenia (45%), thrombocytopenia (34%), and anemia (28%) were among the grades 3 to 4 hematologic toxicities reported. Grades 3 to 4 nonhematologic toxicities that occurred were hyponatremia (45%), hypertension (38%), hypoalbuminemia (24%), fatigue (17%), hyperglycemia (14%), hypokalemia (14%), dehydration (10%), lung infection (10%), and sepsis (10%).

After a median follow-up of 8 months, 20 patients were evaluable. The group had at least 1 response assessment and a median treatment of 6 cycles. The ORR was 75% (95% CI, 50.9%-91.3%) with a complete remission (CR) rate of 30% (95% CI, 11.9%-54.3%). For AITL, the ORR was 85% (95% CI, 54.6-98.1%) with a CR of 38% (95% CI, 13.9%-68.4%). The median DOR was 4.2 months for all responders and 14.3 months for patients who had a CR.

The estimated 1-year PFS was 54.3% and the 3-year PFS was 36.2%. The estimated 1-year OS was 76.0% and the 3-year OS was 51.3%. Among the cohort, 2 patients moved onto consolidative autologous stem cell transplantation in remission, and 4 participants received additional cytotoxic chemotherapy after progression.

“These data justify further evaluation of such novel agents as a frontline strategy,” the investigators stated.

Disclosures: This research was funded by BMS/Celgene. Some of the study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of authors’ disclosures.

Read more of Hematology Advisor’s coverage of the 2021 ASCO Annual Meeting by visiting the conference page.


Ruan J, Zain JM, Palmer B, et al. Multicenter phase II study of romidepsin plus lenalidomide for patients with previously untreated peripheral T-cell lymphoma (PTCL). J Clin Oncol. 2021;39(suppl 15; abstr 7514). doi:10.1200/JCO.2021.39.15_suppl.7514