REscuing bone marrow function in patients with aplaStic anaEmia and bone marrow faiLure post allogEneiC Transplantation (RESELECT)Phase I/II single arm with historical control study assessing the efficacy and safety of Atorvastatin and N-Acetyl Cysteine in the treatment of Poor Graft Function post allogeneic transplantation and relapsed/refractory aplastic anaemia

The Royal Melbourne Hospital0 个研究点目标入组 20 人开始时间: 2020年12月11日最近更新: 2021年11月29日

试验速览

暂无简介。

•1. Poor Graft function OR Relapsed/refractory AA defined as the following
•Poor Graft Function:
•Two Lineage cytopenias defined as
•-Thrombocytopenia
•i)Less than or equal to 30x10^9 /L from D40-D60 OR
•ii)Less than or equal to 50 x10 ^9/L from D60 onwards
•-Neutropenia requiring filgrastim support at any time post D40
•-Hb less than or equal to 80g/L
•Relapsed /Refractory AA:
•Relapse after stem cell transplant OR relapsed post/refractory to 1st line immunosuppression without an unrelated donor identified.
•2. Age greater than or equal to 17 years
•3. ECOG performance status 0-1
•4. Life expectancy > 6 months
•5. Patient’s written informed consent

•1. Active Grade 3-4 acute GVHD
•2. Relapsed or progressive disease on screening bone marrow biopsy or most recent PET imaging.
•3. Active second malignancy currently requiring treatment
•4. Human Immuno-deficiency Virus (HIV) infection.
•5. Any coexisting medical or psychological condition that would preclude participation in the required study procedures.
•6. Female patients who are both lactating and breast-feeding or have a positive serum pregnancy test during the screening period or a positive pregnancy test on Day 1 before first dose of study drug
•7. Prior history of statin induced myopathy
•8. Prior history of severe asthma

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