Busulphan

also known as Busilvex · Busulfan

Developed for: acute myeloid leukemia · myelodysplastic syndrome · myelofibrosis
Investigated by: Adienne SA · Jazz Pharmaceuticals · King's College Hospital NHS Trust · University of Birmingham

today NCT04217278 · Ph 2/3 NCT00915811 · Ph 2

200720082009201020112012201320142015201620172018201920202021202220232024202520262027

Phase	Registry id	Dates	Indication	Sponsor	Status	Outcome
Phase 21 trial
Phase 2	NCT00915811	Jun 2007 → Jun 2011	acute myeloid leukemia, myelodysplastic syndrome	King's College Hospital NHS Trust	Terminated	No outcome recorded
Phase 2/31 trial
Phase 2/3	NCT04217278	Jan 2020 → May 2026 overdue	acute myeloid leukemia, myelodysplastic syndrome	University of Birmingham	Active not recruiting	No outcome recorded
Comparator or background therapy4 trials
Phase 2	NCT03955601 Background	Jul 2018 → Dec 2020	idiopathic aplastic anemia	National Institute of Blood and Marrow Transplant (NIBMT), Pakistan	Unknown	No outcome recorded
Phase 2	NCT01814475 Comparator	Jul 2011 → Dec 2016	myelofibrosis	Italian Group for Bone Marrow Transplantation	Completed	No outcome recorded
Phase 2	NCT00916045 Background	Sep 2009 → Mar 2012	Hodgkins lymphoma, acute myeloid leukemia, chronic lymphocytic leukemia/small lymphocytic lymphoma, myelodysplastic syndrome	King's College Hospital NHS Trust	Terminated	No outcome recorded Stop: Enrollment
Phase 3	NCT01191957 Background	Jan 2008 → Dec 2012	acute myeloid leukemia	Italian Group for Bone Marrow Transplantation	Completed	Met primary

Every value below carries the sentence it was read from. 6 sources stand behind the page.

Field	Value	Cited text
Known as	busulphan	“''Busulphan'' will be used in place of ''TBI'' in equivalent myelotoxic dose to facilitate engraftment” NCT03955601 ↗ 5 NCT00916045 ↗ NCT01191957 ↗ NCT04217278 ↗ NCT00915811 ↗ NCT01814475 ↗
Known as	Busilvex	“Conventional conditioning regimen with intravenous (i.v.) Busulphan (Busilvex), 12.8 mg/kg followed by Cyclophosphamide, 120 mg/kg iv.” NCT01191957 ↗ 1 “Busulphan (Busilvex)” NCT01814475 ↗
Known as	Busulfan	“Busulfan (BU) Plus Fludarabine Vs Intravenous BU Plus Cyclophosphamide as Conditioning Regimens Prior Allogeneic Hematopoetic Stem Cells Transplant (HSCT) in AML” NCT01191957 ↗
Route	Intravenous	“0.8mg/kg intravenously 6 hourly” NCT00915811 ↗