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.
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