Randomized Trial in Adult de Novo Ph Positive ALL With Chemotherapy, Imatinib or Ponatinib, Blinatumomab and SCT

The current Standard of Care (SoC) in younger patients with Ph+ ALL is Imatinib in combination with low-dose chemotherapy, change of TKI in case of persistent MRD above 10-3 after consolidation I and indication for stem cell transplantation. The EVOLVE trial aims to answer three questions challenging the current SoC: Use of Ponatinib compared to Imatinib both in combination with low-dose chemotherapy and consolidation I (randomization I). In MRD good responders: Omit end of therapy in primary care and indication for SCT but continue therapy with TKI, chemotherapy and Blinatumomab as additional antileukemic compound (randomization II). In MRD poor responders: Omit indication for TKI change but give instead Blinatumomab followed by end of therapy in primary care and indication for SCT (non-randomized).

NCT Number	NCT06061094
Lead Sponsor	Goethe University Collaborators: Deutsche Leukämie- & Lymphom-Hilfe, German Federal Ministry of Education and Research
Conditions	Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia
Enrollment	220 participants
Start Date	2023-07-14
Primary Completion	2029-07-01 (estimated)
Study Completion	2029-07-01 (estimated)
Updated on ClinicalTrials.gov	2025-04-29