NCT02757989已完成不适用
Allogeneic Hematopoietic Stem Cell Transplantation in Patients With Low or Intermediate-1 Myelodysplastic Syndrome: A Prospective Multicenter Phase II Study Based on Donor Availability on Behalf of the GFM & SFGM-TC
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 79
- 试验地点
- 74
- 主要终点
- overall survival
研究概览
简要总结
Comparison of survival in patients with or without a matched donor at 36 months
详细描述
Patients with a matched donor (8/8 at molecular level unrelated donor or matched sibling) received an allogeneic hematopoietic stem cell transplantation.
Patients without a matched donor received the best available treatment. All patients will be followed at least 36 months or until the end of the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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 69 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed Informed consent
- •Classical IPSS intermediate 1 or low myelodysplastic syndrome associated with at least one poor prognosis feature:
- •Intermediate or higher risk revised IPSS
- •RBC transfusion dependent anemia and failure to 2 or more lines or therapy (including EPO, Lenalidomide or demethylating agent...)
- •thrombocytopenia < 20 G/L requiring transfusion
- •neutropenia < 0.5 G/L associated with severe infection (defined as requiring hospitalization)
- •Patient aged ≥ 18 and < 70 years For young patients, 18-45 years, Fanconi disease and dyskeratosis should be ruled out
- •Patient for whom a transplantation from a matched donor, (8/8 (HLA A, B, C, DRB1) identical at molecular level)unrelated donor or matched sibling), is considered irrespective of donor availability
- •Performance status 0-2 on the Eastern Cooperative Oncology Group (ECOG) Scale (At time of screening)
- •Negative pregnancy and adequate contraception (including in male patients wishing to father), if relevant.
- •Wash-out of at least 30 days since a previous treatment with Vidaza, Lenalidomide, EPO or any other treatment inducing cytopenias.
排除标准
- •MDS classified according to classical IPSS as intermediate 2 or High risk
- •Transformation in Acute myeloid Leukemia (AML)
- •Severe active infection or any other uncontrolled severe condition.
- •Organ dysfunctions including the following
- •Hepatic : total bilirubin > 2 times upper limit of normal (ULN) (except moderate unconjugated hyperbilirubinemia due to intra medullary hemolysis or Gilbert syndrome) , alanine transaminase (ALT) and aspartate transaminase (AST) > 3xULN
- •Symptomatic respiratory chronic failure
- •Symptomatic cardiac failure
- •Renal clearance < 60ml/min
- •Prior malignancy (except in situ cervix carcinoma, limited basal cell carcinoma, or other tumors if not active during the last 3 years)
- •MDS with the following causal germline disease : Fanconi anemia, GATA2 related syndromes and telomere disorders
结局指标
主要结局
overall survival
时间窗: 36 months
comparison of overall survival in patients with or without a matched donor (8/8 unrelated donor or matched sibling) at 36 months
次要结局
- quality of life(12, 24 and 36 months)
- proportion of patients with iron overload(16 months)
- number of patients with adverse events grade III and IV as assessed by CTCAE v4.0(36 months)
- number of patients with complete response at 36 month(36 months)
- efficiency of chelation(3 and 16 months)
- number of patients with transformation in AML at 36 month(36 months)
- evolution of innovative iron markers including Non-transferrin binding iron (NTBI), labile plasmatic Iron (LPI) and Hepcidine(3 and 16 months)
研究者
研究点 (74)
Loading locations...
相似试验
已完成
不适用
HLA-mismatched allogeneic hematopoietic stem cell transplantation for advanced hematological malignancy using low-dose alemtuzumabadvanced hematological malignancyJPRN-UMIN000007913Division of Hematology, Saitama Medical Center, Jichi Medical University14
招募中
2 期
Allogeneic Hematopoietic Stem Cell Transplant for Patients With Inborn Errors of ImmunityLymphoproliferative DisordersAutoimmune LymphoproliferativeImmune System DiseasesPrimary T-cell Immunodeficiency DisordersCommon Variable ImmunodeficiencyNCT04339777National Cancer Institute (NCI)66
终止
不适用
Allogeneic Hematopoietic Stem Cell Transplantation in HIV-1 Infected PatientsHIV-1 InfectionNCT02732457Kirby Institute5
招募中
2 期
A Phase II Study of Allogeneic Hematopoietic Stem Cell Transplant for Subjects With VEXAS (Vacuoles, E1 Enzyme, X-linked, Autoinflammatory, Somatic) SyndromeImmunodeficiencyHematopoietic Stem Cell TransplantationNCT05027945National Cancer Institute (NCI)54
进行中（未招募）
1 期
Stem cells transplant from matched donor in patients with chronic myeloid leukemia who do not improve with TKI therapyChronic Myeloid LeukemiaMedDRA version: 18.0Level: LLTClassification code 10054352Term: Chronic phase chronic myeloid leukemiaSystem Organ Class: 100000004864EUCTR2014-003126-40-ITIVERSITà DEGLI STUDI MILANO BICOCCA20