Trial in AML Secondary to MPNs Patients, Unfit for Intensive Chemotherapy, Investigating a Treatment Combination Including Decitabine and Venetoclax

PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

101

Participants

Timeline

Start Date

December 3, 2021

Primary Completion Date

October 25, 2024

Study Completion Date

April 30, 2026

Conditions
Acute Myeloid Leukemia
Interventions
DRUG

Venetoclax+Decitabine

"Patients will receive treatment with a combination of decitabine and venetoclax as follows:~* Decitabine 20 mg/sqm intravenously on days 1 to 5 of 28-days courses~* Venetoclax 400 mg per day orally on days 1 to 28 of 28-days courses; a dose escalation period is provided at first cycle (ramp-up) in which VEN is administered as follows: 100 mg on day -2, 200 mg on day -1, and 400 mg on day 1, a dose that is continued subsequently, daily, for 28-day cycles.~In case of achievement of response, the treatment will be continued until disease progression or death by other causes."

Trial Locations (33)

Unknown

Ematologia A.O. SS. Antonio e Biagio e Cesare Arrigo, Alessandria

Ematologia AOU delle Marche, Ancona

Ematologia AOU Policlinico Bari, Bari

Ematologia ASST Papa Giovanni XXIII, Bergamo

Ematologia IRCCS AOU di Bologna, Bologna

Ematologia ASST Spedali Civili di Brescia, Brescia

Ematologia Businco, Cagliari

Ematologia Istituto Oncologico Veneto IRCCS, Castelfranco Veneto

Ematologia AOU Policlinico Rodolico-San Marco, Catania

Ematologia A.O.U Arcispedale S.Anna, Cona

Ematologia Ospedale A.Carle, Cuneo

Az. Ospedaliero - Universitaria Careggi, Florence

Ematologia IRCCS Ospedale Policlinico San Martino, Genova

Ematologia AOU di Modena, Modena

Ematologia AORN Cardarelli, Napoli

Ematologia Federico II, Napoli

Ematologia P.O. A.Tortora, Pagani

Ematologia AOU Policlinico Giaccone, Palermo

Ematologia Santa Maria della Misericordia, Perugia

Ematologia PO Santo Spirito ASL Pescara, Pescara

Ematologia Ospedale S.M.delle Croci, Ravenna

Ematologia AOU S.Andrea, Roma

Ematologia Fondazione PTV, Roma

Ematologia Ospedale Sant'Eugenio, Roma

Ematologia Policlinico Gemelli, Roma

Ematologia Policlinico Umberto I, Roma

Ematologia Policlinico Santa Maria alle Scotte, Siena

Ematologia A.O.S. Maria Di Terni, Terni

Ematologia Città della Salute e della Scienza, Torino

Ematologia ORDINE MAURIZIANO DI TORINO, Torino

Ematologia Santa Maria della Misericordia, Udine

Ematologia ASST SETTE LAGHI, Varese

Ematologia Ospedale Belcolle, Viterbo

All Listed Sponsors
lead

Gruppo Italiano Malattie EMatologiche dell'Adulto

OTHER