WHO ICTRP trial

A phase II multicentric study in adults with acute myelogenous leukaemia (AML)…

EUCTR2009-016601-42-FR · EU Clinical Trials Register · Not Recruiting

Key facts

Trial ID EUCTR2009-016601-42-FR
Public title A phase II multicentric study in adults with acute myelogenous leukaemia (AML) in first complete remission (CR1) using IV BuCy2 in a once daily Bu regimen targeting a narrow therapeutic window prior to hematopoietic stem cell transplantation.
Scientific title A phase II multicentric study in adults with acute myelogenous leukaemia (AML) in first complete remission (CR1) using IV BuCy2 in a once daily Bu regimen targeting a narrow therapeutic window prior to hematopoietic stem cell transplantation.
Primary sponsor PIERRE FABRE MEDICAMENT
Registry EU Clinical Trials Register
Recruitment status Not Recruiting
Study type Interventional clinical trial of medicinal product
Phase Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no
Countries France;Spain;Italy
Conditions Acute myeloid leukaemia MedDRA version: 12.1 Level: PT Classification code 10000881 Term:
Interventions Trade Name: BUSILVEX Product Name: BUSILVEX Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: Busulfan Current Sponsor code: F60002 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal…
Registration date Apr 1, 2010
Target size 28
Secondary IDs F60002 IN 202 G0
Registry page clinicaltrialsregister.eu

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Source: World Health Organization (WHO), International Clinical Trials Registry Platform (ICTRP) · Source date:

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