A phase II study of haploidentical peripheral blood stem cell transplantation with post-transplant cyclophosphamide as Graft versus Host Disease (GVHD) prophylaxis

St Vincent's Hospital Sydney0 个研究点目标入组 70 人开始时间: 2017年1月27日最近更新: 2019年7月15日

试验速览

暂无简介。

•1. Patients 16 – 70 years of age
•2. Recipients must have a haematological malignancy with a significant risk of relapse (as measured by the Disease Risk Index), where allogeneic transplant is indicated.
•3. Adults without a readily available matched related or unrelated donor.
•4. Patients must have a first-degree relative who are 3/6 to 4/6 HLA matched.
•5. Patients with an HCT-CI/age > or equal to 3 will receive non-myeloablative conditioning.
•6. Adequate cardiac (LVEF >50%), pulmonary (DLCO/VA >50%) and renal function (Creatinine Clearance >60ml/min).
•7. Informed written consent.
•8. Haematological malignancies may be (but are not limited to):
•a. AMLCR1 (high risk cytogenetics, FLT-3 positive), CR2
•b. AML refractory disease with less than or equal 2 CIBMTR adverse risk factors.
•c. tAML/MDS: with less than or equal 2 CIBMTR adverse risk factors
•d. MDSIPSS Int-2/High risk
•e. MPD eligible for HSCT
•f. CML prior AP/BT in CP2; inadequate response to treatment of CP CML:
•g. ALL CR1 (high risk cytogenetics or MRD+ve), CR2
•h. Lymphoma (NHL or HL) in remission

•1.Pregnancy.
•2. Positive serology for HIV.
•3. Refractory Central Nervous System (CNS) disease.
•4. Serious organ dysfunction: LVEF <50%, FEV1, FVC, DLCO <50%of predicted, LFT > 5 x the upper limit of normal, or creatinine clearance < 40 ml/min .
•5. Life expectancy less than 60 days.
•6. Unable or unwilling to provide written informed consent

发起方

St Vincent's Hospital Sydney