NCT02059720Unknown3 期
Haplo-mismatch Donor Stem Cell Transplantation (SCT) Versus Autologous SCT Followed or Not by Maintenance Therapy, for Patients With Acute Myeloid Leukemia (AML) in First Remission: A Chinese Randomized Multicenter Study
The First Affiliated Hospital of Soochow University1 个研究点 分布在 1 个国家目标入组 212 人开始时间: 2014年2月1日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 212
- 试验地点
- 1
- 主要终点
- Leukemia-Free Survival
研究概览
简要总结
A multicentre, prospective, open-label clinical study, including a randomized controlled study in low or intermediate-risk group patients, and a cohort study of maintenance treatment with decitabine after ASCT.
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
- 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
- •Age >= 18y
- •Diagnosed as AML (except acute promyelocytic leukemia M3) for the first time
- •Minimal Residual Disease (MRD) test can be achieved (molecular biology first if applicatable, and/or cytogenetics and/or immunophenotyping)
- •Presence of an available haplo-mismatch related donor
排除标准
- •Contra-indications of chemotherapy or hematopoietic stem cell transplantation
- •Presence of an available identical sibling donor or a 10/10 HLA loci-matched unrelated donor
- •Participating in other clinical trials concerning the prophylaxis of disease recurrence after ASCT
- •No effective contraception
- •Pregnant or lactating females
- •Other causes which are not suitable for the trial in investigator's consideration
结局指标
主要结局
Leukemia-Free Survival
时间窗: Five years
Defined as the survival duration starting at the day of graft infusion, terminating at the day of death, morphological relapse or the end of follow-up.
次要结局
- Overall survival(Five years)
- Cumulative relapse incidence(Five years)
- Non-relapse Mortality(Five years)
- Cumulative incidence of engraftment(180 days)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
2 期
Trial of Haploidentical Stem Cell Transplantation for Haematological CancersHodgkin's LymphomaNon-Hodgkin's LymphomaAcute Myeloid LeukaemiaAcute Lymphoblastic LeukaemiaChronic Myeloid LeukaemiaChronic Lymphocytic LeukaemiaAcquired Bone Marrow Failure SyndromesOther Haematological Malignancies Unrelated HSCT IndicatedMyelodysplastic SyndromeNCT01597219University College, London77
终止
不适用
Randomized Clinical Study Assessing Haplo vs. URD in AMLAcute Myeloid LeukemiaNCT04067180Karolinska Institutet18
进行中（未招募）
2 期
HLA-Mismatched Unrelated Donor Hematopoietic Cell Transplantation With Post-Transplantation CyclophosphamideAcute Myelogenous LeukemiaMyelodysplastic SyndromesLymphomaChronic Lymphocytic LeukemiaAcute Lymphoblastic LeukemiaChronic Myelogenous LeukemiaAcute LeukemiaMixed Phenotype Acute LeukemiaNCT04904588Center for International Blood and Marrow Transplant Research300
终止
1 期
Donor Stem Cell Transplant in Treating Patients With High Risk Acute Myeloid LeukemiaAdult Acute Megakaryoblastic Leukemia (M7)Adult Acute Monoblastic Leukemia (M5a)Adult Acute Monocytic Leukemia (M5b)Adult Acute Myeloblastic Leukemia With Maturation (M2)Adult Acute Myeloblastic Leukemia Without Maturation (M1)Adult Acute Myeloid Leukemia in RemissionAdult Acute Myeloid Leukemia With 11q23 (MLL) AbnormalitiesAdult Acute Myeloid Leukemia With Del(5q)Adult Acute Myeloid Leukemia With Inv(16)(p13;q22)Adult Acute Myeloid Leukemia With t(16;16)(p13;q22)Adult Acute Myeloid Leukemia With t(8;21)(q22;q22)Adult Acute Myelomonocytic Leukemia (M4)Adult Erythroleukemia (M6a)Adult Pure Erythroid Leukemia (M6b)Childhood Acute Erythroleukemia (M6)Childhood Acute Megakaryocytic Leukemia (M7)Childhood Acute Monoblastic Leukemia (M5a)Childhood Acute Monocytic Leukemia (M5b)Childhood Acute Myeloblastic Leukemia With Maturation (M2)Childhood Acute Myeloblastic Leukemia Without Maturation (M1)Childhood Acute Myeloid Leukemia in RemissionChildhood Acute Myelomonocytic Leukemia (M4)Recurrent Adult Acute Myeloid LeukemiaRecurrent Childhood Acute Myeloid LeukemiaSecondary Acute Myeloid LeukemiaUntreated Adult Acute Myeloid LeukemiaUntreated Childhood Acute Myeloid Leukemia and Other Myeloid MalignanciesNCT01801046University of Southern California10
招募中
1 期
Prospective, Single-arm, Multicenter Clinical Study on Haploidentical Hematopoietic Stem Cell Transplantation in Patients With MRD Positive CD19+ALL Treated With Conditioning Regimens Containing BlinatumomabAcute Lymphoblastic LeukemiaNCT06125106Zhejiang University31