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ALL/MRD2014 trial: Continuous dasatinib and reduced-intensity chemotherapy in patients with Ph+ ALL
The combination of TKIs and chemotherapy has improved outcomes for patients with Ph+ ALL.1 Results from the ALL/MRD2008 trial showed that imatinib/dasanitib in combination with chemotherapy was associated with high response rates in newly diagnosed patients with Ph+ ALL.1 In ALL/MRD2008, dasatinib was intermittently administered for 14 days during each consolidation chemotherapy cycle.1 The prospective, multicenter, phase II ALL/MRD2014 trial (UMIN000012382), conducted by the FBMTG, assessed the efficacy and safety of dasatinib plus chemotherapy in patients aged 16–65 years with Ph+ ALL (N = 61).1 This trial used a modified protocol compared with the ALL/MRD2008 trial, incorporating continuous dasatinib use and reduced-intensity chemotherapy.1 Results were published in the European Journal of Haematology by Nagafuji et al.1
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Key learnings |
| Post-induction, the CR rate was 96.7%, with 3-year EFS and OS rates of 51% and 76%, respectively. |
| Patients who underwent allo-HSCT in CR1 (n = 39) demonstrated superior outcomes (3-year EFS and OS rates of 64% and 87%, respectively), with MRD-negative status before transplant being a key prognostic factor for improved survival (EFS: 71% vs 29%; p = 0.010; OS: 94% vs 57%; p = 0.003). |
| The modified ALL/MRD2014 protocol with continuous dasatinib and reduced chemotherapy intensity led to survival outcomes comparable with the prior ALL/MRD2008 trial but showed a non-significant increased CIR (39% vs 26%; p = 0.305) and lower NRM (10% vs 21%; p = 0.181). |
| These findings demonstrate that continuous dasatinib-based chemotherapy followed by allo-HSCT is associated with favorable outcomes in patients with Ph+ ALL. MRD-negativity prior to allo-HSCT is a strong prognostic indicator, emphasizing the clinical importance of deep molecular remission in treatment decision-making. |
Abbreviations: ALL, acute lymphoblastic leukemia; allo-HSCT, allogeneic hematopoietic stem cell transplantation; CIR, cumulative incidence of relapse; CR, complete remission; CR1, first CR; EFS, event-free survival; FBMTG, Fukuoka Blood and Marrow Transplantation Group; MRD, measurable residual disease; NRM, non-relapse mortality; OS, overall survival; Ph+, Philadelphia chromosome-positive; TKI, tyrosine kinase inhibitor.
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