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GMALL-PH-01 phase II trial final analysis: Dasatinib plus standard chemotherapy for adult patients with Ph+ ALL
The introduction of TKI plus chemotherapy combination therapy has significantly improved outcomes in younger patients (aged <55 years) with Ph+ ALL.1 Dasatinib is a second-generation TKI with demonstrated efficacy in patients with relapsed Ph+ ALL, in combination with intensive chemotherapy for pediatric and younger adult patients with Ph+ ALL, and in combination with lower dose chemotherapy in elderly patients with Ph+ ALL.1 The multicenter, open-label, phase II GMALL-PH-01 trial (NCT01724879) assessed the efficacy and safety of dasatinib in combination with standard chemotherapy according to the GMALL 07/2003 protocol* in 19 patients aged 18–55 years with newly diagnosed and previously untreated Ph+ ALL.1 The primary objective was to evaluate the feasibility of the combination in adult ALL, and enhance the rate of early molecular remissions.1 Results were published in Leukemia & Lymphoma by Lang et al.1
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Key learnings |
| The combination of dasatinib + chemotherapy achieved deep molecular responses, with a CR rate of 79% following induction and an overall MRD negativity rate of 62.5%. |
| The 1-year OS rate was 68%, with a 2-year OS rate in patients achieving a CR (n = 15) and after allo-HSCT (n = 14) of 87% and 86%, respectively. |
| Despite promising molecular responses, the regimen was associated with an early mortality rate of 21%, primarily due to sepsis and hemorrhage, leading to premature study termination. |
| Given the high toxicity observed with dasatinib + chemotherapy, future strategies should focus on optimizing the use of dasatinib and other TKI-based regimens by reducing chemotherapy intensity or incorporating immunotherapy with the aim of improving safety while maintaining efficacy. |
*A risk-adapted treatment strategy for adult ALL combining intensive chemotherapy, CNS prophylaxis, targeted therapy (e.g., tyrosine kinase inhibitors for Ph+ ALL), and, for high-risk patients, allo-HSCT to improve survival and remission outcomes.
Abbreviations: ALL, acute lymphoblastic leukemia; allo-HSCT, allogeneic hematopoietic stem cell transplantation; CNS, central nervous system; CR, complete remission; GMALL, German Multicenter Study Group for Adult ALL; MRD, measurable residual disease; OS, overall survival; Ph+, Philadelphia chromosome positive; TKI, tyrosine kinase inhibitor.
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