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

Recruiting Phase 2 Interventional Study
Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 – 65
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
220 (estimated)
Sponsor
Goethe University · Other
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About This Trial
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 chemoth…
Trial Locations
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Eligibility Criteria
Inclusion 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 therapy, hydroxyurea, a sin…
Contacts

Nicola Goekbuget, MD

0049-6963016365

goekbuget@em.uni-frankfurt.de

CONTACT

Fabian Lang, MD

0049-69630183044

f.lang@med.uni-frankfurt.de

CONTACT