A phase I trial of combined azacitidine and lenalidomide salvage therapy in patients with acute myeloid leukaemia and myelodysplasia who relapse after allogeneic stem cell transplantation.

niversity of Birmingham (UK)0 个研究点目标入组 31 人开始时间: 2014年2月25日最近更新: 2021年8月24日

适应症

试验速览

阶段: 1 期
状态: 已完成
发起方
入组人数: 31

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

2016 Funder report results see attached file ISRCTN98163167 Clinical Trial Summary Report.pdf [1.0a] (added 09/08/2021) 2019 Results article in https://pubmed.ncbi.nlm.nih.gov/30653424/ (added 09/08/2021)

研究设计

研究类型: Interventional

入排标准

性别: All

入选标准

•Current inclusion criteria as of 10/05/2018:
•1. Patients with relapsed AML or MDS following an alemtuzumab- or anti-thymocyte globulin (ATG)-based reduced intensity conditioned allogeneic stem cell transplant using a sibling or unrelated donor
•2. Patients able to receive treatment as an outpatient
•3. Patients must be willing to comply with the lenalidomide risk management programme
•4. Patients must have given written informed consent
•5. Patients willing and able to comply with scheduled study visits and laboratory tests
•Previous inclusion criteria:
•1. Patients with relapsed AML following an alemtuzumab or anti-thymocyte globulin (ATG)-based reduced intensity conditioned allogeneic stem cell transplant using a sibling or unrelated donor
•2. Patients able to receive treatment as an outpatient
•3. Patients must be willing to comply with the lenalidomide risk management programme
•4. Patients must have given written informed consent
•5. Patients willing and able to comply with scheduled study visits and laboratory tests

排除标准

•1. Patients with active acute or chronic extensive graft-versus-host-disease
•(GvHD), or a history of grade 3 or 4 GvHD
•2. Patients with hepatic or renal impairment defined as follows:
•Total bilirubin = 2.5 x upper limit of normal (ULN)*
•Aspartate aminotransferase (AST) or Alanine aminotransferase (ALT) = 3.0 x ULN
•Estimated Glomerular Filtration Rate (eGFR) = 40mls/min
•*Patients with elevated bilirubin due to Gilbert's syndrome are eligible
•3. Patients who have received anti-tumour
•therapies, including prior experimental agents or approved anti-tumour
•small molecules and biologics, within 28 days before the start of protocol treatment
•4. Patients with active symptomatic fungal, bacterial, and/or viral infection
•5. Patients with contraindications to receiving azacitidine or lenalidomide
•6. Patients with any other condition that in the Investigators opinion would affect the patient's participation in the trial

研究者

发起方

niversity of Birmingham (UK)

相似试验

Unknown

不适用

Clinical Research for Azacitidine Combined With Low-dose Dasatinib in Maintenance Therapy of Acute Myeloid LeukemiaAcute Myeloid Leukemia

NCT05042531LanZhou University30

已完成

1 期

Azacitidine in Combination With Mitoxantrone, Etoposide Phosphate, and Cytarabine in Treating Patients With Relapsed or Refractory Acute Myeloid LeukemiaRecurrent Adult Acute Myeloid LeukemiaRefractory Acute Myeloid Leukemia

NCT01249430National Cancer Institute (NCI)24

招募中

2 期

A Phase II Study of the Combination of Azacitidine and Pembrolizumab for Patients Relapsed/Refractory Hodgkin's LymphomaHodgkin's Lymphoma

NCT05355051M.D. Anderson Cancer Center24

已完成

1 期

NCT01839240University of Chicago50

Unknown

不适用

Efficacy and Safety of Azacitidine Combined With Interferon in the Treatment of Post-transplant RecurrenceHSCTEfficacy and Safety

NCT04078399Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine30