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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
220
Imatinib 600mg QD plus Chemotherapy
Ponatinib 45 mg QD plus chemotherapy
Patients with molecular failure or intermediate response receive one cycle Blinatumomab before SCT; Patients with molecular CR randomized to the experimental arm receive 3 cycles Blinatumomab + chemotherapy
Patients with molecular CR randomized to the standard arm have an indication for SCT; patients with molecular failure or intermediate response have an indication for SCT. SCT is not part of the trial.
Uniklinik RWTH Aachen
Aachen, Germany
RECRUITINGKlinikum Aschaffenburg
Aschaffenburg, Germany
RECRUITINGKlinikum Augsburg
Augsburg, Germany
RECRUITINGHelios Klinikum Bad Saarow
Bad Saarow, Germany
OS in MolCR patients treated with TKI-Chemo-Blina versus (vs) EOT with indication for SCT (Standard of Care)
Probability of overall survival up to 4 years from randomization I in patients with mo-lecular remission after consolidation 1 comparing a combination treatment of TKI, Blina-tumomab and chemotherapy versus EOT with indication for SCT
Time frame: up to 4 years from randomization I
Rate of molecular complete remission at week 11 after consolidation
Rate of molecular complete remission at week 11 after consolidation with chemotherapy in combination with Ponatinb versus Imatinib
Time frame: week 11 after consolidation
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Klinikum Bayreuth
Bayreuth, Germany
RECRUITINGVivantes Klinikum am Urban
Berlin, Germany
RECRUITINGCharité Universitätsmedizin Berlin
Berlin, Germany
RECRUITINGVivantes Klinikum Neukölln
Berlin, Germany
RECRUITINGHelios Klinikum Berlin-Buch
Berlin, Germany
RECRUITINGCharite Berlin Virchow Klinikum
Berlin, Germany
RECRUITING...and 75 more locations