Study of pharmacokinetics of intravenous busulfan (Busilvex ®) in the conditioning allogeneic transplantation in patients with high-risk hematological disease. - BX-PK-IPC2013-016

INSTITUT PAOLI CALMETTES0 个研究点目标入组 33 人开始时间: 2014年4月10日最近更新: 2020年7月27日

适应症

试验速览

暂无简介。

•1. Consent to participate signed
•2. Affiliation to a social security scheme, or beneficiary of such a system,
•3. Related or unrelated donor HLA identical: All patients age = 55 years with hematologic malignancies and considered eligible for an allogeneic transplant from a donor genotype and phenotype identical identical 10/10,
•4. The basic pathology should be considered chemo-sensitive complete or partial remission (CR, PR) or stable disease (SD).
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 33
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•1. Pregnant or likely to be (without effective contraception) or breastfeeding woman
•2. Person in an emergency situation, a major person under a legal protection measure (major guardianship, curatorship or judicial protection), or unable to consent,
•3. Inability to undergo medical monitoring test for geographical, social or psychological reasons,
•4. Cons-indications for allogeneic transplantation,
•5. Age <55 years
•6. Previous allograft
•7. Convert cancerous progressive disease concomitantly
•8. Evolutionary psychiatric condition,
•9. Seropositive for human immunodeficiency virus or hepatitis C scalable requiring treatment,
•10. Women of childbearing potential and men, in the absence of effective contraception during treatment and for 12 months after stopping treatment.

发起方

INSTITUT PAOLI CALMETTES