CAR HEMATOTOX independently predicts outcomes after CD19 CAR-T therapy for acute lymphoblastic leukemia.
Клиническое исследование I фазыСтатьяМногоцентровое исследованиеНазвание и аннотация: Перевод в очереди
Обработка статьи · этапы, ошибки и управление
Загрузка состояния…
Ошибки и ограничения
История · было → стало
Состояние обновляется каждые 5 секунд, пока блок открыт. Процент показывается только там, где известен объём работы. Пауза останавливает продолжение этапа; текущий запрос к источнику может завершиться.
Valtis Yannis K, Lin Chenyu, Nemirovsky David, Devlin Sean, Rejeski Kai, Curran Kevin J, Wang Xiuyan, Shah Nirali N, Jeyakumar Nikeshan, Miller Katharine, Zhang Amy, Kota Vamsi K, Al Darobi Ali H, Muhsen Ibrahim, Sasine Joshua, Aldoss Ibrahim, Advani Anjali S, Reshef Ran, Chen Evan C, Kopmar Noam, Tsai Stephanie B, Hilal Talal, Shah Bijal D, Faramand Rawan, Solh Melhem M, Tan Virginia, Bezerra Evandro, Battiwalla Minoo, Ramakrishnan Aravind, Mathews John, Shaughnessy Paul, Mountjoy Luke, Hoeg Rasmus T, Dykes Kaitlyn C, Logan Aaron C, Kumaran Muthu V, Schwartz Marc, Tracy Sean, Moore Jozal, Odstrcil Bobillo Silvina, Frey Noelle V, Connor Matthew, Ladha Abdullah, Dholaria Bhagirathbhai, Sutherland Katherine, Roloff Gregory W, Muffly Lori S, Park Jae H
Аннотация
Chimeric antigen receptor (CAR) T-cell (CAR-T) treatment for B-cell acute lymphoblastic leukemia (ALL) induces high initial response rates, but most patients relapse. Low disease burden (often defined as <5% blasts in the bone marrow) is associated with better outcomes. CAR HEMATOTOX (HT) is a score using prelymphodepletion hematologic and inflammatory parameters to predict outcomes in lymphoma. Here, we assess its prognostic utility in a large multicenter adult B-cell ALL cohort. Patients who received brexucabtagene autoleucel across 33 centers in North America were included as part of the Real-World Outcomes Collaborative of CAR-T in Adult ALL (ROCCA) consortium. An independent cohort of 61 patients with ALL treated with an investigational CD19 CAR-T therapy at 1 center was also described. Among 199 ROCCA consortium patients, 43 (22%) patients with HTlow scores had lower rates of delayed neutrophil recovery than those with HThigh scores (26% vs 52%, P = .002) and fewer severe infections (2.5% vs 18.8%, P = .011). They also had higher response rates, overall survival (OS), and event-free survival (EFS), as well as lower nonrelapse mortality and cumulative incidence of relapse. The survival differences remained significant after multivariable adjustment for disease burden and other covariates. In the investigational cohort of 61 patients, patients with HTlow scores had improved OS and EFS, as well as higher peak CAR-T expansion. In summary, CAR HT score is a prognostic factor independent of disease burden in adult ALL. HTlow score is associated with superior outcomes after CD19 CAR-Ts and higher CAR-T expansion in a single-center cohort. These trials were registered at www.clinicaltrials.gov as #NCT01044069 and #NCT01860937.