NCT05788679招募中2 期
A Phase II Multicenter Single-armed Study Using Subject-specific Minimal Residual Disease Markers to Adopt Treatment After Allogeneic Stem Cell Transplantation for Subjects With Myelodysplastic Syndrome
Karolinska University Hospital1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2022年11月22日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Clinical event defined as relapse or death within 1 year from first MRD+ sample
研究概览
简要总结
The goal of this interventional study is to evaluate if pre-emptive intervention using Azacitidine and / or donor lymphocytes or tapering of immune suppression in measurable residual disease (MRD) positive subjects can prevent clinical relapse. Participants will undergo MRD surveillance and be subjected to intervention in case of MRD positivity. Results will be compared with NMDSG14B, part one, in which MRD was analyzed in included patients without recieving intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed informed consent
- •Age ≥ 18 years
- •Subjects eligible for SCT
- •Subjects having the disease MDS, mixed myelodysplastic/myeloproliferative syndrome or AML with myelodysplasia related dysplasia and 20-29% marrow blasts
- •All female subjects of childbearing potential have to have negative pregnancy test within 2 weeks prior to inclusion to the study
排除标准
- •No traceable genetic aberration identified either in screening next generation sequencing panel or next generation sequencing panel performed at diagnosis
- •Uncontrolled hypertension, heart, liver, kidney related or other uncontrolled medical or psychiatric disorders
- •Mental inability, reluctance or language difficulties that results in difficulty understanding the meaning of study participation
研究组 & 干预措施
Intervention in MRD positive patients
Experimental
Azacitidine and / or Donor lymphocytes or tapering of immune suppression
干预措施: Azacitidine (Drug)
Intervention in MRD positive patients
Experimental
Azacitidine and / or Donor lymphocytes or tapering of immune suppression
干预措施: Donor lymphocytes (Other)
Intervention in MRD positive patients
Experimental
Azacitidine and / or Donor lymphocytes or tapering of immune suppression
干预措施: Tapering of immune suppression (Other)
结局指标
主要结局
Clinical event defined as relapse or death within 1 year from first MRD+ sample
时间窗: Within 1 year from first MRD+ sample
次要结局
- Incidence and severity of graft-versus host disease(From transplantation until 2y after transplantation)
- Safety, adverse events reporting(After start of Azacitidine until 30 days after last azacitidine injection)
- Relapse-free survival(From transplantation until 2y after transplantation)
- Overall survival(From transplantation until 2y after transplantation)
- Number of MRD+ patients achieving MRD negativity(From MRD positivity until 2y after transplantation)
研究者
Magnus Tobiasson
Coordinating investigator
Karolinska University Hospital
研究点 (1)
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