Low Dose Dasatinib Is Not As Active in a CML CP Cohort Enriched with Intermediate/High-Risk CML Chronic Phase: A Phase IIb Multi-Center Trial

Background- A lower dose of Dasatinib has been shown to have excellent results in CML in CP, even better than standard doses in a single-center study using the innovator drug (Naqvi et al, Cancer, January 2020). We conducted a multicenter trial using a lower dose of generic Dasatinib (Invista, Dr. Reddy's, Hyderabad, India) to see the outcomes. Methods- This is a phase II multi-center investigator initiated study conducted between October 2020 till September 2021. Patients were enrolled from 9 centers across India. The inclusion criteria were CML in CP, aged 18-60 years without any co-morbidities and another cancer. They were enrolled in the trial after a written informed consent. Initial assessment included complete blood counts, bone marrow examination including karyotype, FISH for t (9;22) and serum chemistries. They were given 50 mg daily of generic Dasatinib. Blood counts were monitored once in 1-2 weeks for the first 2 months and monthly thereafter. Dasatinib drug levels and RQPCR was monitored at 3-, 6- and 12-month intervals. The response was defined as per ELN 2020 criteria. The main outcome measure was CCyR (or equivalent molecular response 更多