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 vs. CT elderly AM

European Group for Blood and Marrow trasnplantation0 个研究点目标入组 231 人开始时间: 2009年7月22日最近更新: 2017年1月9日

适应症

试验速览

暂无简介。

•Inclusion criteria at registration:
•- Age >= 60years and <= 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
•- Karnofsky score > 70 (see appendix of the trial protocol)
•- Written informed consent
•Inclusion criteria at randomization:
•- Patient is registered in this trial
•- Complete remission must be confirmed after first consolidation cycle according to the response criteria enlisted in the appendix of the
•trial protocol with the following exception regarding the peripheral blood recovery (B1):
•Peripheral Blood Recovery (PBR): ANC >=1.5x10^9/l or 1500/mm^3, transfusion independent platelet count >=50x10^9/l
•(i.e. 48 h after last transfusion) and no leukemic blasts in the peripheral blood and no dysplasia
•- AND platelet count must be increasing
•-Matching (10/10: HLA-A, -B, -C, DRB1 and DQ) related or unrelated donor is available
•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 116
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 115

•Exclusion criteria at registration
•- AML FAB M3
•- HIV positivity
•Participation in another clinical trial without prior consent of the coordinating investigator, patients may exceptionally take part in a further study only if
•- The second study exclusively concerns induction therapy
•- Consolidation cycle one and two are given according to the accredited study group policy
•- No investigational drugs are used post registration for the HCT vs CT in eldery AML study.
•- Documentation for the HCT vs CT in eldery AML study is not compromised. Second hand data from foreign study is not accepted
•Exclusion criteria at randomization:
•- Organ dysfunction
•- Patients with creatinine clearance < 50 ml/min
•- Cardiac ejection fraction < 40%
•- 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
•- Patients with poorly controlled hypertension
•- Patient has undergone more than one consolidation cycle
•- More than 5 months (>150 days) after diagnosis
•- Participation in another clinical trial without prior consent of the coordinating investigator

发起方

European Group for Blood and Marrow trasnplantation