A Randomized Phase III study comparing conventional chemotherapy to low dose total body irradiation-based conditioning and hematopoietic cell transplantation from related and unrelated donors as consolidation therapy for older Patients with AML in first Complete Remission - HCT versus CT elderly AM

EBMT0 个研究点目标入组 218 人开始时间: 2010年5月6日最近更新: 2017年2月6日

适应症

试验速览

暂无简介。

•- Age > or équal 60years and < ou equal 75 years
•- AML as defined by WHO
•- Refractory anemia with excess of blasts (RAEB)
•- primary and secondary AML
•- First complete remission following one or two cycles of induction chemotherapy, according to current participating cooperative group protocols
•- Presence of an HLA-identical familiy donor or an unrelated donor (6/6 or 10/10 according to the center policy)
•- a male donor is preferred for male recipients
•- Karnofsky score > 70 (see appendix D)
•- Written informed consent
•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
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

•- AML FAB M3
•- Patients aged > 70 years with a comorbidity score =2 according to the modified charlson comobidity index (Sorror score –see Appendix)
•- Organ dysfunction
•- Patients with creatinine clearance < 50 ml/min
•- Cardiac ejection fraction < 50%
•- Severe defects in pulmonary function testing (defects are currently categorized as mild, moderate and severe) as defined by the pulmonary consultant, or receiving supplementary continuous oxygen
•- Liver function tests: total bilirubin > 2x the upper limit of normal, SGOT and SGPT - 4x the upper limit of normal
•- Karnofsky score £ 60 (see appendix D )
•- Patients with poorly controlled hypertension
•- HIV positivity
•- Treament in other clinical studies with investigational drugs
•- Exclusion criteria apply at time of randomization

发起方