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ACTIVE NOT RECRUITING
NCT04476199
PHASE2

Venetoclax and Decitabine Assessment in Patients (≥60 - <75 Years) with Newly Diagnosed AML Eligible for Allo-SCT

Sponsor: Gruppo Italiano Trapianto di Midollo Osseo

View on ClinicalTrials.gov

Summary

This trial is a no profit, prospective, phase II, multicentre, non-randomised, uncontrolled, single group assignment, open label study to evaluate the safety and efficacy of the "chemo-free" combination Venetoclax plus Decitabine (VEN-DEC) as "bridge" to allo-SCT in elderly (≥ 60 - \< 75 years) AML patients. The primary objective is to evaluate the proportion of elderly (≥60 - \<75 years) patients with newly diagnosed AML, eligible for allo-SCT, treated with the "chemo-free" combination Venetoclax plus Decitabine (VEN-DEC) who get allo-SCT in CR/Cri/MLFS.

Official title: Phase II Study on Venetoclax (VEN) Plus Decitabine (DEC) (VEN-DEC) for Elderly (≥60 <75years) Patients with Newly Diagnosed Acute Myeloid Leukemia (AML) Elegible for Allogeneic Stem Cell Transplantation (allo-SCT)

Key Details

Gender

All

Age Range

60 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

100

Start Date

2019-12-09

Completion Date

2025-06-30

Last Updated

2025-01-06

Healthy Volunteers

No

Interventions

COMBINATION_PRODUCT

Venetoclax and Decitabine

The prognosis of acute myeloid leukemia (AML) patients aged over 60 years is poor and allogeneic stem cell transplantation (allo-SCT) is the only curative option.The association VEN-DEC is a promising combination therapy for AML elderly patients who are fit and eligible for allo-SCT.

Locations (25)

USD, Trapianti di Midollo osseo, Azienda Spedali Civili di Brescia

Brescia, Brescia, Italy

Unità Terapia Intensiva Ematologica e terapia cellulari - casa della sofferenza

San Giovanni Rotondo, Foggia, Italy

UO Ematologia e TMO - Ospedale C. Panico

Tricase, Lecce, Italy

Ospedale San Gerardo

Monza, Monza, Italy

Clinica di Ematologia. AOU Ospedali Riuniti di Ancona

Ancona, Italy

UOC di Ematologia, Ospedale C e G Mazzoni

Ascoli Piceno, Italy

U.O. Ematologia con Trapianto, Policlinico di Bari

Bari, Italy

Ospedale Seragnoli Malpighi

Bologna, Italy

Ospedale Policlinico di Catania, TMO

Catania, Italy

Struttura Complessa di Ematologia, Azienda Ospedaliera Santa Croce e Carle

Cuneo, Italy

Terapie Cellulari e Medicina Trasfusionale, Ospedale Careggi

Florence, Italy

UO Ematologia, Programma Trapianti IRCCS Ospedale Policlinico San Martino, Genova

Genova, Italy

Centro Trapianto Fondazione IRCCS Cà Granda - Osp. Maggiore

Milan, Italy

Div. di Ematologia e TMO, Istituto Nazionale Tumori

Milan, Italy

Div. di Ematologia, Talamona, Osp. Niguarda, Ca-Granda

Milan, Italy

Istituto Clinico Humanitas, Oncologia ed Ematologia

Milan, Italy

Unità Operativa di Ematologia e Trapianto Midollo Osseo (UTMO), Ospedale San Raffaele di Milano

Milan, Italy

UOSC Ematologia con Trapianto CSE, AORN A. Cardarelli, AORN Cardarelli

Naples, Italy

CTMO Osp. V. Cervello Azienda Ospedaliera Ospedali Riuniti Villa Sofia Cervello

Palermo, Italy

Dip.di Ematologia, Osp. Civile di Pescara, Unità di Terapia Intensiva Ematologica per il Trapianto Emopoietico

Pescara, Italy

CTMO Centro Unico, Regionale Trapianti di Cellule Staminali e Terapie Cellulari, "A. Neri", Grande Osp. Bianchi, Melacrino Morelli

Reggio Calabria, Italy

Policlinico Tor Vergata

Roma, Italy

A.O.U. Citta della Salute e della Scienza

Torino, Italy

UOC di Ematologia, Osp. dell'Angelo

Venezia, Italy

Div. di Ematologia - Unità di TMO e Oncoematologia Pediatrica Policlinico GB Rossi

Verona, Italy