This study will test the effectiveness and safety of Venetoclax in combination with standard induction regimen for patients with acute leukemia and poor prognosis.
Intensive treatment of Acute Leukemia, multidrug based chemotherapy induction, achieves complete remission (CR) rates ranging from 50% to 80%. Nonetheless, the majority (60- 70%) of responding patients will eventually relapse. Patients with non-low risk leukemia according most diffuse risk scores have a poor prognosis and a short survival. For these patient traditional chemotherapy seems to be ineffective, even with BMT consolidation, probably due to activation of survival pathways in Leukemia cells, so that novel therapeutic interventions should be attempted. This study will test the effectiveness and safety of Venetoclax, a selective BCL2 inhibitor, in combination with standard induction regimen. Inhibiting anti-apoptotic pathway of BCL2, the investigators expect to improve success rate of standard chemotherapies.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
124
Venetoclax add in combination with fludarabine, cyratabine and idarubicine
Ematologia - ASST Papa Giovanni XXIII
Number of patients achieving complete response (CR) after course 1 or course 2 if course 2 is administered (CR + CRi + CRp)
Efficacy in new onset, non ELN Low risk AML (safety run-in, part1, and part2). Effectiveness of Venetoclax added in combination with chemotherapy in obtaining Complete remission in new onset, non ELN Low risk AML (safety run-in, part1, and part2).
Time frame: At 24 months from study entry
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Bergamo, Italy
Aou Di Bologna - Policlinico S. Orsola-Malpighi - Uoc Ematologia
Bologna, Italy
Spedali Civili - Azienda Ospedaliera U.O. Ematologia
Brescia, Italy
Università di Catania - Cattedra di Ematologia - Ospedale "Ferrarotto"
Catania, Italy
A.O.U. Careggi - Ematologia
Florence, Italy
Irccs Aou San Martino - Genova - Uo Clinica Ematologica
Genova, Italy
Istituto Scientifico Romagnoli per lo Studio e la Cura dei Tumori IRST
Meldola, Italy
Fondazione Irccs "Istituto Nazionale Tumori" - Milano - Sc Ematologia
Milan, Italy
Ospedale Niguarda "Ca Granda" SC Ematologia
Milan, Italy
U.O. Ematologia e Trapianto di Midollo Ist. Scientifico Ospedale San Raffaele
Milan, Italy
...and 12 more locations