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临床试验/NCT05510505
NCT05510505招募中2 期

A Prospective, Randomized, Multi-center Study to Assess the Efficacy and Safety of GVHD Prophylaxis by Addition of CD20 Monoclonal Antibody to the Conditioning Regimen in Severe Aplastic Anemia Patients With Treatment of Allogeneic HSCT

The First Affiliated Hospital of Soochow University1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2021年12月30日最近更新:
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适应症
干预措施

试验速览

阶段
2 期
状态
招募中
发起方
入组人数
100
试验地点
1
主要终点
GVHD incidence
研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

Objectives 2.1 Primary objectives

  1. To observe and compare incidence and severity of aGVHD and cGVHD between the two arms within 2 years after transplantation.

  2. To observe and compare the engraftment rate between the two arms. 3) To observe and compare the incidence of infections between the two arms. 2.2 Secondary objectives

  1. To conduct pharmacogenomic assay in CD20 arm(treatment arm) before conditioning and monitor plasma concentration of CD20 dynamically（7d、14d、28d、56d、91d）.
  2. To monitor levels of B cells in peripheral blood dynamically (+90d、+180d、+270d、+360d、+450d、+540d、+630d、+720d) in all patients.
  3. To observe and compare the incidence of PTLD between the two arms.
  4. To observe and compare immunoglobulin levels after transplantation in all patients.
  5. To evaluate transplant-related mortality.
  6. To evaluate the effect on hematopoietic reconstruction.

详细描述

  1. Study design 3.1 Principle of design: prospective, randomized, control, open label 3.2 Subjects: patients with SAA undergoing allogeneic HSCT 3.3 Grouping: In this study, central randomization was used for random enrolment (1:1). After signing the informed consent, patients were randomized into rituximab conditioning group (test group) or non- rituximab conditioning group (control group). Treatment was assigned on a randomized basis according to a 1:1 ratio. The test group and the control group each will include 100 cases.

3.4 Study schedule: This clinical research is to be completed from September 2020 to September 2023.

  1. Subject enrollment 36months
  2. Transplantation to the end of follow-up 24months
  3. Data collection and report writing 3months In total 63months

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Investigator)

入排标准

年龄范围
— 至 50 Years（Child, Adult）
性别
All
接受健康志愿者
否

入选标准

  • •Subjects eligible for inclusion in this study must meet all of the following criteria:
  • •SAA characterized Bone marrow cellularity< 25%, or 25-50% with <30% residual hematopoietic cells and pancytopenia, with at least two of the following parameters in peripheral blood Absolute neutrophil count < 0.5*10E9/L Platelet count < 20*10E9/L Absolute reticulocyte count < 20*10E9/L
  • •ALL patients will undergo allo-HSCT.
  • •Subjects aged <50 years old with KPS performance status ≥70 at the same time.
  • •Aspartate aminotransferase (AST) , alanine aminotransferase (ALT) and alkaline phosphatase≤2 times the upper limit of normal (ULN). Blood urea nitrogen and Creatinine ≤1.25 times ULN.
  • •Cardiac function of subjects must meet all of the following requirements: ECG examination do not reveal any acute myocardial infarction, arrhythmia, or first-degree or higher atrioventricular block. No signs of heart failure. No carrying of active rheumatoid heart disease. Chest radiograph or physical examination do not indicate an enlarged heart.
  • •ALL subjects show none contraindication for allogeneic hematopoietic stem cell transplantation.
  • •Patients enrolled in the rituximab group have no contraindications for the use of rituximab.
  • •Patients and their clients are willing to perform hematopoietic stem cell transplantation.
  • •Potential donor is accessible.
  • •Patients have no anti-HLA antibodies.

排除标准

  • •Subject who is unable comprehend or is unwilling to sign an informed consent form or consent form due to severe physical or mental illness resulting in a survival of less than 2 years.
  • •Presence of clinically active uncontrolled significant chronic infections (including bacterial, fungal or viral infection), such as dental caries, otitis media, sinusitis, etc., need to be carried out after effective control.
  • •Past medical history of severe pulmonary dysfunction.
  • •Past medical history of diabetes with a propensity for ketoacidosis.
  • •Presence of severe coagulopathy, thrombophlebitis or pulmonary embolism.
  • •Presence of decompensated liver insufficiency or active hepatitis.
  • •Presence of history of severe autoimmune disease.
  • •Past medical history of thyroid dysfunction with currently abnormal thyroid function.
  • •Any concomitant malignancies that have not been disease-free for 5 years.
  • •Past medical history of hypersensitivity to biological products (including antibiotics).
  • •Pregnant or nursing woman.
  • •Inherited bone marrow failure.

研究组 & 干预措施

ATG arm (control group)

Active Comparator

4.2.1 Matched sibling donor 1) ATG arm (control group) Fludarabine 30mg/m2/d×6d（-7d ~ -2d）+ Cyclophosphamide 50mg/kg/d×2d （-4d ~ -3d）+ ATG 2.5mg/kg/d×5d（-8d ~ -4d）

4.2.2 Unrelated donor and haploidentical donor

  1. ATG arm (control group) Busulfan 3.2 mg/kg/d（0.8 mg/kg，q6h）×2d（-7d ~ -6d） + Cyclophosphamide 50mg/kg/d×4d （-5d ~ -2d）+ ATG 2.5mg/kg/d×4d（-5d ~ -2d）

干预措施: ATG (Drug)

ATG + CD20 monoclonal antibody (test arm)

Experimental

4.2.1 Matched sibling donor 2) ATG + CD20 monoclonal antibody (test arm) Fludarabine 30mg/m2/d×6d（-7d ~ -2d） + Cyclophosphamide 50mg/kg/d×2d （-4d ~ -3d）+ ATG 2.5mg/kg/d×5d（-8d ~ -4d）+ CD20 monoclonal antibody 375mg/m2, -1d

4.2.2 Unrelated donor and haploidentical donor 2) ATG + CD20 monoclonal antibody (test arm) Busulfan 3.2 mg/kg/d（0.8 mg/kg，q6h）×2d（-7d ~ -6d） + Cyclophosphamide 50mg/kg/d×4d （-5d ~ -2d）+ ATG 2.5mg/kg/d×4d（-5d ~ -2d）+ CD20 monoclonal antibody 375mg/m2, -1d

干预措施: CD20 monoclonal antibody (Drug)

结局指标

主要结局

GVHD incidence

时间窗: 2 years

GVHD incidence, location and grade. Infection incidence and recurrence rate.

次要结局

  • Infection incidence(2 years)
  • transplant related mortality(2 years)
  • GVHD-free survival rate(2 years)
  • overall survival rate(2 years)

研究者

发起方
The First Affiliated Hospital of Soochow University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Wu Depei

Professor

The First Affiliated Hospital of Soochow University

研究点 (1)

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