Among pediatric patients with newly diagnosed, ALK-positive anaplastic large cell lymphoma (ALCL), adding brentuximab vedotin to chemotherapy appears to be safe, and possibly effective for improving overall survival (OS), according to research published in Blood.

ALCL, a mature T cell non-Hodgkin lymphoma, accounts for as many as 15% of all pediatric cases of lymphoma. CD30 expression and pleomorphic disease cells both characterize ALCL, which is frequently advanced at disease presentation. Further, more than 95% of ALCL cases are ALK-positive.

Brentuximab vedotin is a CD30-targeting antibody that has previously shown a high overall response rate (ORR) among pediatric patients with ALCL. For this phase 2 study (Children’s Oncology Group trial ANHL12P1; Identifier: NCT01979536), researchers evaluated the tolerability, as well as event-free survival (EFS) and OS, of brentuximab vedotin with chemotherapy among pediatric patients with ALCL.

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Between 2013 and 2017, 68 pediatric patients with ALCL were enrolled. The median age was 12 (range, 2-21), 43 (63.2%) patients were male, 48 (70.6%) patients were white, and 70.6% of patients had stage III disease at baseline. The most common disease sites were lymph nodes (95.6%), soft tissue (29.4%), and bone (23.5%).

All enrolled patients received 6 cycles of chemotherapy and brentuximab vedotin. Sixty-six of 67 patients evaluable for toxicity completed the 6 chemotherapy cycles; 63 of 67 patients received all 6 cycles of brentuximab vedotin.

Of the 399 patient-cycles evaluable for adverse events, the most common grade 4 events were neutropenia (76 cycles; 19%), thrombocytopenia (34 cycles; 8.5%), and anemia (0.8%). The most common grade 3 events were anemia (55 cycles; 13.8%), febrile neutropenia (52 cycles; 13%), and thrombocytopenia (22 cycles; 5.5%). No toxicity-related deaths were reported.

The 2-year EFS was 79.1%; 2-year OS was 97%. Of 14 relapses noted, 1 occurred during therapy.

“In summary, [this] arm of ANHL12P1 demonstrated that the addition of brentuximab vedotin prevented relapses during therapy and resulted in efficacy at least as good as with previously reported regimens used to treat children with nonlocalized ALCL,” the authors wrote. “The study further demonstrated that brentuximab vedotin did not increase toxicity and was feasible to give in a 21-day cycle.”

Disclosure: The study author(s) declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of authors’ disclosures. 


Lowe EJ, Reilly AF, Lim MS, et al. Brentuximab vedotin in combination with chemotherapy for pediatric patients with ALK+ ALCL: results of COG trial ANHL12P1. Blood. 2021;137(26):3595-603. doi:10.1182/blood.2020009806