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 additio

Trial Details

NCT ID
NCT06061094
Phase
PHASE2
Sponsor
Goethe University
Status
RECRUITING
Cancer Type
Leukemia
Interventions
  • Imatinib
  • Ponatinib
  • Blinatumomab
  • Indication for stem cell transplantation
Locations (sample)
  • Aachen, Germany|50.77664,6.08342
  • Aschaffenburg, Germany|49.97704,9.15214
  • Augsburg, Germany|48.37154,10.89851
  • Bad Saarow, Germany|52.28333,14.06667
  • Bayreuth, Germany|49.94782,11.57893

Key Eligibility Criteria

  • Male or female patients \>= 18 years, \<=65 years
  • Philadelphia chromosome or BCR-ABL1 positive ALL
  • Not previously treated except with corticosteroids ≤ 7 days, standard GMALL prephase with dexamethasone and cyclophosphamide including intrathecal …
  • ECOG performance status ≤2

For full eligibility, visit ClinicalTrials.gov.

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