Diffuse large B-cell lymphoma (DLBCL), either concurrent with or transformed from follicular lymphoma (FL) is often excluded from clinical trials. Lenalidomide has response rates of 45% in relapsed transformed DLBCL. Herein we present an analysis of MC078E, a phase II clinical trial testing lenalidomide plus R-CHOP (R2CHOP) for patients with untreated transformed/concurrent DLBCL (NCT00670358). Adult patients with transformed or concurrent DLBCL were included. Patients received six cycles of rituximab, cyclophosphamide, doxorubicin, vincristine, prednisone (R-CHOP) with lenalidomide 25 mg days 1–10 of each cycle. The primary outcome was progression-free survival (PFS) at 24 months. Secondary outcomes were response rates, event-free survival (EFS), and overall survival (OS). Thirty-nine patients were accrued from August 5, 2013 to July 28, 2020 and 33 were eligible by central pathology review. The median age was 64 (24–80) years, 18 (54%) were male, 25 (76%) were concurrent and 8 (24%) were transformed DLBCL. The PFS, EFS, and OS rates at 24 months were 84.4% (CI95: 67.2–94.7%), 84.5% (CI95: 72.9–98%), and 97.0% (CI95: 91.3–100%), respectively. R2CHOP is effective in concurrent and transformed DLBCL. The study supports the inclusion of anthracycline-naive transformed and concurrent DLBCL in future clinical trials of novel immunomodulatory analogues.
Bibliographical noteFunding Information:
Yucai Wang: research funding from Incyte, Innocare, Novartis, Genentech and member of the advisory board of Eli Lilly; Stephen M. Ansell: research funding from Bristol Myer Squibb (BMS), Seattle Genetics, Takeda, Al Therapeutics, Regeneron, Affimed, Trillium, ADC therapeutics; Thomas E. Witzig: consultancy in Celgene, MorphoSys, Abbvie, Incyte, Spectrum, and research funding: Celgene, Acerta, Karyopharm Therapeutics, Immune Design; Grzegorz S. Nowakowski: consultancy in Celgene/BMS, MorphoSys, Ryvu, Kite, Kymera, Curis, Seattle Genetics and research funding from Celgene/BMS, MorphoSys, Nanostring; Rebecca L. King: research funding from BMS/Celgene. The remaining authors declare no competing interests.
© 2021, The Author(s).
PubMed: MeSH publication types
- Clinical Trial, Phase II
- Journal Article