1. Dasatinib plus prednisone as induction and consolidation for adults with Ph‐positive acute lymphoblastic leukaemia: A single‐arm, multicentre, phase 2 trial.
- Author
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Xie, Mixue, Lu, Ying, Ouyang, Guifang, Li, Xueying, Shi, Ting, Yang, Min, Le, Jing, Hu, Huixian, Zhang, Li, Feng, Weiying, Meng, Haitao, Mai, Wenyuan, Wei, Juying, Qian, Jiejing, Xu, Gaixiang, Yang, Chunmei, Zhou, De, Lin, Yin, Qian, Suying, and Kuang, Yuemin
- Subjects
LYMPHOBLASTIC leukemia ,HEMATOPOIETIC stem cell transplantation ,ACUTE leukemia ,DASATINIB ,OLDER patients - Abstract
Summary: To reducing chemotherapy‐related toxicity, the chemo‐free regimens become a new trend of Ph + ALL treatment. Therefore, we conducted a phase 2 trial of dasatinib plus prednisone, as induction (Course I) and early consolidation (Courses II and III) treating newly diagnosed Ph + ALL. The trial was registered at www.chictr.org.cn, ChiCTR2000038053. Forty‐one patients were enrolled from 15 hospitals. The complete remission (CR) was 95% (39/41), including two elderly induction deaths. By the end of Course III, 25.6% (10/39) of patients achieved a complete molecular response. With a median follow‐up of 15.4 months, 2‐year disease‐free survival (DFS) were 100% and 33% for patients who receiving haematopoietic stem cell transplantation (HSCT) at CR1 and receiving chemotherapy alone respectively. When censored at time of HSCT, 2‐year DFS were 51% and 45% for young and elderly patients (p = 0.987). 2‐year overall survival were 45%, 86% and 100% for patients without HSCT, receiving HSCT after relapse and receiving HSCT at CR1 respectively. A total of 12 patients had marrow recurrences and one had CNS relapse, with 38% occurred early (between Courses I and III). IKZF1 gene deletion was shown to be associated with relapse (p = 0.019). This chemo‐free induction and early consolidation regimen was efficacious and well‐tolerated in de novo Ph + ALL. Allogeneic HSCT conferred definite survival advantage after chemo‐free induction. [ABSTRACT FROM AUTHOR]
- Published
- 2023
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