Randomized Trial in Adult de Novo Ph Positive ALL With Chemotherapy, Imatinib or Ponatinib, Blinatumomab and SCT
Status:
Recruiting
Trial end date:
2029-07-01
Target enrollment:
Participant gender:
Summary
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).
Phase:
Phase 2
Details
Lead Sponsor:
Goethe University
Collaborators:
Deutsche Leukämie- & Lymphom-Hilfe German Federal Ministry of Education and Research