Study Evaluating the Efficacy of Allogeneic Transplant Conditioning With Adaptive Dose Busulfan Intravenous (Busilvex®) in Patients at High Risk of Carrying Blood Diseases

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02483325
• Date of registration: 24/06/2015
• Prospective Registration: No
• Primary sponsor: Institut Paoli-Calmettes
• Public title: Study Evaluating the Efficacy of Allogeneic Transplant Conditioning With Adaptive Dose Busulfan Intravenous (Busilvex®) in Patients at High Risk of Carrying Blood Diseases BX-PK
• Scientific title: Phase II Study Evaluating the Efficacy of Allogeneic Transplant Conditioning With Adaptive Dose Busulfan Intravenous (Busilvex®) in Patients at High Risk of Carrying Blood Diseases
• Date of first enrolment: September 2014
• Target sample size: 33
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02483325
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 2

Countries of recruitment

France

Key inclusion & exclusion criteria

Inclusion Criteria :

- Informed consent signed,

- Patient affiliated to a social security system or benefiting from such a system,

- Related HLA identical donor or unrelated HLA identical donor :

all patients aged > 55 years with hematological malignancy and deemed eligible for an
allogeneic transplant from a geno-identical donor and pheno-identical 10/10

- the basic pathology should be considered "chemo-sensitive" complete or partial remission
(CR, PR) or stable disease

Exclusion Criteria :

- Pregnant or lactating woman or without contraception (for child bearing potential
women)

- Patient deprived of liberty or under supervision of a guardian

- Impossibility to undergo medical examinations of the study for geographical, social or
psychological reasons

- Usual contra-indications for allogenic transplant

- Aged < 55 years

- History of allogenic transplant

- Concomitant neoplastic disease

- Evolutive psychiatric disease

- HIV seropositivity or C hepatitis under treatment

- Women of childbearing age or man, in the absence of effective contraception during
treatment and up to 12 months after treatment discontinuation



Age minimum: 55 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Hematological Diseases

Intervention(s)

Drug: Allogeneic transplant conditioning

Primary Outcome(s)

rates progression free survival 2 years [Time Frame: Time to progression or death]

Secondary Outcome(s)

Plasmatic concentration of Busulfan [Time Frame: Time from inclusion until Day -1 before allogenic transplantation]

Secondary ID(s)

BX-PK-IPC 2013-016

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Agence de La Biomédecine