Panobinostat Maintenance After HSCT fo High-risk AML and MDS

PHASE3TerminatedINTERVENTIONAL
Enrollment

52

Participants

Timeline

Start Date

July 24, 2018

Primary Completion Date

February 13, 2023

Study Completion Date

February 13, 2023

Conditions
Acute Myeloid Leukaemia (AML)Myelodysplastic Syndromes (MDS)
Interventions
DRUG

Panobinostat

"Panobinostat should be taken orally once on each scheduled day at about the same time, either with or without food. Each dose of panobinostat should be taken with a cup of water.~The capsules should be swallowed as whole. If vomiting occurs during the course of treatment, no re-dosing is allowed before the next scheduled dose. If one dose is forgotten during the morning on a scheduled treatment day then the missed dose should be taken on that same day within 12 hours. After more than 12 hours, that day's dose should be withheld, and the patient should wait to take panobinostat until the next schedule treatment day. The patient should then continue treatment with the original dosing schedule.~Panobinostat will be administered at a dose of 20 mg three times weekly (TIW) every second week and will be dosed on a flat scale of mg/day and not by weight or body surface area.~Panobinostat will be dispensed as a 20 mg capsule or as two 10 mg capsules."

Trial Locations (19)

3015

Erasmus University Medical Center, Rotterdam

39120

Otto-von-Guericke University, Magdeburg

70376

Robert Bosch Krankenhaus, Stuttgart

90419

Klinikum Nürnberg Nord, Nuremberg

07747

University Hospital Jena, Jena

04103

Universitätsklinikum Leipzig, Leipzig

Unknown

Klinikum Augsburg, Augsburg

University Hospital Bonn, Bonn

University Hospital Frankfurt, Frankfurt

University Hospital Hamburg-Eppendorf, Hamburg

Universitätsmedizin Mainz, Mainz

Klinikum Mannheim, Mannheim

Philipps-Universität Marburg, Marburg

University Hospital Münster, Münster

Maastricht University Medical Center, Maastricht

01307

Universtity Hospital Dresden, Dresden

1081 HV

Amsterdam University Medical Center - VUMC, Amsterdam

9713 GZ

University Medical Center Groningen, Groningen

6500 HB

Radboud UMC, Nijmegen

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Stichting Hemato-Oncologie voor Volwassenen Nederland

OTHER

collaborator

Polish Adult Leukemia Group

OTHER

collaborator

Schweizerische Arbeitsgemeinschaft für klinische Krebsforschung

UNKNOWN

lead

Goethe University

OTHER

NCT04326764 - Panobinostat Maintenance After HSCT fo High-risk AML and MDS | Biotech Hunter | Biotech Hunter