Reversing poor graft function with eltrombopag after allogeneIc hematopoietic cell transplantation : a prospective, phase II study by the SFGM-TC. - REGALIA

CHRU of Lille0 个研究点目标入组 25 人开始时间: 2018年10月9日最近更新: 2019年2月28日

适应症

试验速览

暂无简介。

•- Patient age = 6 years old
•- Diagnosis of poor graft function defined as:
•Patient = day+60 after allo-HCT,
•Persisting thrombocytopenia on two different samples over at least two weeks (platelet < 20G/L with transfusion requirement) +/- neutropenia (ANC <1G/L) +/- anemia (Hb <8g/dL or transfusion requirement),
•Full donor chimerism on whole blood (= 95%),
•Biopsy proven hypocellular marrow without evidence of myelodysplasia
•No evidence for relapse,
•No evidence for active acute or chronic graft versus host disease,
•Absence of active viral infection (EBV, CMV, ADENOVIRUS, PARVOVIRUS B19),
•Absence of B9/B12 deficiency,
•Absence of hypothyroidism,
•Absence of hypogonadism,
•Absence of dialysis,
•Absence of thrombotic microangiopathy,
•Absence of macrophage activation syndrome,
•No other known causes of poor graft function.
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 5
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 15
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 5

•Criteria for poor graft function not fulfilled (see above),
•Patients aged less than 6 years old (or unable to swallow),
•Hepatic impairment (Child-Pugh = 5),
•Hypersensitivity to eltrombopag or to any of the excipients,
•Patients with any contra-indication to eltrombopag, filgrastim,
•Unable to understand the investigational nature of the study or give informed consent,
•History of congestive heart failure, arrhythmia requiring chronic treatment, arterial or venous,
•Thrombosis (not excluding line thrombosis) within the last 1 year, or myocardial infarction within 3 months before enrollment,
•ECOG Performance Status of 3 or greater,
•Pregnant and/or lactating women,
•Freedom privacy.

发起方

CHRU of Lille