Review Authors Advocate Greater Use of Single-Arm Trials to Speed Development of Novel Treatment Modalities for Adult ALL

Rapid progress in research and therapy for acute lymphoblastic leukemia (ALL) in adults “questions the value of the traditional research methodologies,” contend Hagop Kantarian, MD, and Elias Jabbour, MD, of the University of Texas M.D. Anderson Cancer Center, in a review article published in Oncology Times in September.

Reliance “on recommendations and guidelines like the ones from the National Comprehensive Cancer Network (NCCN) may be challenged by recent strategies that show impressive results, even though they may be derived from single-arm or single-institution trials,” they write. They review some of the novel therapeutic strategies “which we believe will radically change the therapeutic approach in non-childhood ALL soon.”

Optimizing new research modalities, including but not limited to bispecific T-cell engagers (BiTEs) and CAR T-cell therapies aimed at CD19, CD20, CD22, and other targets, in combination regimens “could be done safely and expeditiously in well-designed and carefully monitored single-arm trials, rather than in large-scale randomized trials,” Kantarian and Jabbour write. Such a strategy would, they say, reduce the time needed to identify optimal regimens, which would then be tested in randomized trials, ultimately accelerating patient access to these new modalities.

  • Kantarjian H, Jabbour E. Acute Lymphoblastic Leukemia. Research & Therapy in 2021. Oncology Times. 2021 Sept 5;43(17):1,11-12,18. doi: 10.1097/01.COT.0000791796.99084.b2

Tags: transplantation, Treatment, leukemia, acute, ALL, cell therapy, Review, trials, development, authors, single-arm, novel treatment