Long-term Study Evaluating the Effect of Givinostat in Patients With Chronic Myeloproliferative Neoplasms

PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

90

Participants

Timeline

Start Date

March 31, 2013

Primary Completion Date

December 31, 2026

Study Completion Date

December 31, 2026

Conditions
Chronic Myeloproliferative Neoplasms
Interventions
DRUG

givinostat

"Patients will continue at their last tolerable dose and treatment schedule of givinostat monotherapy. Givinostat is a histone-deacetylases inhibitor. The product will be supplied as hard gelatine capsules for oral administration at the strength of 50 mg, 75 mg and/or 100 mg each.~If patients previously received givinostat in combination with other drugs during a core protocol or a compassionate use program, they will be treated at their last tolerable dose of this combination."

Trial Locations (15)

10117

Charite Research Organization GmbH, Berlin

20122

Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico UOS Oncoematologia anziano, Milan

24127

Azienda Ospedaliera Papa Giovanni XXIII, Bergamo

27100

Fondazione I.R.C.C.S.-Policlinico San Matteo, Pavia, Pavia

36100

Ospedale San Bortolo, Vicenza, Vicenza

50134

Azienda Ospedaliero-Universitaria Careggi, Florence, Florence

65124

"Azienda Unità Sanitaria Locale - Presidio Ospedaliero Spirito Santo, Pescara", Pescara

70124

Azienda Ospedaliero-Universitaria Policlinico Consorziale, Bari, Bari

70125

Istituto Tumori Giovanni Paolo II IRCCS Ospedale Oncologico di Bari, Bari

79106

Universitaetsklinikum Freiburg, Innere Medizin I - Haematologie und Onkologie, Freiburg im Breisgau

80131

"Azienda Ospedaliera Universitaria Università degli Studi Federico II, Naple", Naples

89124

"Azienda Ospedaliera Bianchi-Melacrino-Morelli", Reggio Calabria

00128

"Università Campus Bio-Medico, Rome", Rome

BT9 7BL

Belfast City Hospital, Belfast

TR1 3LJ

Royal Cornwall Hospital, Truro

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Italfarmaco

INDUSTRY