Trial in AML Secondary to MPNs Patients, Unfit for Intensive Chemotherapy, Investigating a Treatment Combination Including Decitabine and Venetoclax
Condition(s) studied
Investigational drug(s) / intervention(s)
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.
Study summary
Prospective, multi-center, intervention, open clinical trial for the treatment of AML secondary to MPN in patients unfit for intensive chemotherapy investigating a combination regimen including VEN and DEC.
Eligibility
Primary outcome measure(s)
- Efficacy of VEN-DEC regimen (event free survival) — at 1 year
Evaluation of the event free survival at 1 year of an experimental VEN-DEC combination arm in patients with AML secondary to MPN and unfit for intensive therapeutic strategy
Trial sites (33)
| Facility | City | Region | Status |
|---|---|---|---|
| Ematologia A.O. SS. Antonio e Biagio e Cesare Arrigo | Alessandria | Italy | |
| Ematologia AOU delle Marche | Ancona | Italy | |
| Ematologia AOU Policlinico Bari | Bari | Italy | |
| Ematologia ASST Papa Giovanni XXIII | Bergamo | Italy | |
| Ematologia IRCCS AOU di Bologna | Bologna | Italy | |
| Ematologia ASST Spedali Civili di Brescia | Brescia | Italy | |
| Ematologia Businco | Cagliari | Italy | |
| Ematologia Istituto Oncologico Veneto IRCCS | Castelfranco Veneto | Italy | |
| Ematologia AOU Policlinico Rodolico-San Marco | Catania | Italy | |
| Ematologia A.O.U Arcispedale S.Anna | Cona | Italy | |
| Ematologia Ospedale A.Carle | Cuneo | Italy | |
| Az. Ospedaliero - Universitaria Careggi | Florence | Italy | |
| Ematologia IRCCS Ospedale Policlinico San Martino | Genova | Italy | |
| Ematologia AOU di Modena | Modena | Italy | |
| Ematologia AORN Cardarelli | Naples | Italy | |
| Ematologia Federico II | Naples | Italy | |
| Ematologia P.O. A.Tortora | Pagani | Italy | |
| Ematologia AOU Policlinico Giaccone | Palermo | Italy | |
| Ematologia Santa Maria della Misericordia | Perugia | Italy | |
| Ematologia PO Santo Spirito ASL Pescara | Pescara | Italy | |
| Ematologia Ospedale S.M.delle Croci | Ravenna | Italy | |
| Ematologia AOU S.Andrea | Roma | Italy | |
| Ematologia Fondazione PTV | Roma | Italy | |
| Ematologia Ospedale Sant'Eugenio | Roma | Italy | |
| Ematologia Policlinico Gemelli | Roma | Italy | |
| Ematologia Policlinico Umberto I | Roma | Italy | |
| Ematologia Policlinico Santa Maria alle Scotte | Siena | Italy | |
| Ematologia A.O.S. Maria Di Terni | Terni | Italy | |
| Ematologia Città della Salute e della Scienza | Torino | Italy | |
| Ematologia ORDINE MAURIZIANO DI TORINO | Torino | Italy | |
| Ematologia Santa Maria della Misericordia | Udine | Italy | |
| Ematologia ASST SETTE LAGHI | Varese | Italy | |
| Ematologia Ospedale Belcolle | Viterbo | Italy |
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT04763928 on ClinicalTrials.gov ↗ ← All trials in Italy