NCT04857645已完成2 期
A Phase II Prospective Study "GFM-DACORAL-DLI" ASTX727 and Donor Lymphocyte Infusions After Allogenic Stem Cell Transplantation in Very High Risk MDS or AML Patients
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 57
- 试验地点
- 12
- 主要终点
- Disease free Survival (DFS) at one year post transplant
研究概览
简要总结
Study of early administration of ASTX727 associated with late Donor Lymphocyte Infusions after allogenic stem cell transplantation in very high risk MDS or AML patients
详细描述
Prospective study of early administration of ASTX727 associated with late Donor Lymphocyte Infusions after allogenic stem cell transplantation in very high risk MDS or AML patients
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged from 18 to 70 years
- •MDS or AML with unfavorable genetics defined as follow:
- •4 or more cytogenetic abnormalities or
- •3 cytogenetic abnormalities and TP53 or other unfavorable mutations (ASXL1, RUNX1) or
- •3 cytogenetic abnormalities and monosomal karyotype or
- •mutations involving EVI1
- •AML patients should have received chemotherapy
- •Marrow blast < 20% for MDS and < 10% for AML post chemotherapy
- •For MDS : Revised IPSS poor or very poor ; For AML : ELN adverse risk
- •Non-proliferative disease
- •A donor is available (HLA matched or mismatched)
- •Adequate contraception in women < 50 years and for men. Subjects must agree to use, and to be able to comply with, effective contraception without interruption, at least the first six months after transplant, throughout the entire duration of study drug therapy and for at least 6 months for women and 3 months for men after the last dose of study drug therapy.
排除标准
- •ECOG 3 or more
- •Cancer less than 2 years before inclusion or cancer not in remission the last 2 years before inclusion (except in situ cancer or baso cellular cancer)
- •Cardiac failure with Ejection Fraction < 50%
- •Creatininemia level > 150 µmol/L
- •Liver enzyme > 3 N
- •Conjugated bilirubinemia > 25 µmol/L
- •MDS occurring in patients with Fanconi anemia or congenital dyskeratosis
- •Proliferative disease in patients not in remission: White Blood Cell (WBC) > 15 G/L or use of continuous cytotoxic to maintain WBC < 15 G/L
- •AML with marrow or peripheral blast count higher than 10% after chemotherapy
- •Known allergy or hypersensitivity to the investigational agent or decitabine or its metabolites or formulation excipients
- •No contraception
- •Pregnant or breastfeeding women
研究组 & 干预措施
ASTX727 treatment
Experimental
干预措施: ASTX727 (Drug)
ASTX727 treatment
Experimental
干预措施: Donor Lymphocyte Infusions (Other)
结局指标
主要结局
Disease free Survival (DFS) at one year post transplant
时间窗: 1 year post transplant
Measure of time during which no sign of progression is found
次要结局
- Overall Survival (OS) at one year post transplant(1 year post transplant)
- Overall Survival (OS) at two years post transplant(2 years post transplant)
- Risk factors for DFS, OS and non-relapse mortality at 1 and 2 years(1 and 2 years)
研究者
研究点 (12)
Loading locations...
相似试验
撤回
2 期
A Phase I/II Trial to Assess the Efficacy and Toxicity of ASTX727 (Oral Decitabine/Cedazuridine) for the Treatment of Hematological Neoplasms After Allogeneic Stem Cell TransplantationAllogeneic Stem Cell TransplantationNCT06297629M.D. Anderson Cancer Center
已完成
1 期
Phase 1-2 Study of Low Dose ASTX727 (ASTX727 LD) in Lower Risk MDSMyelodysplastic SyndromesNCT03502668Taiho Oncology, Inc.160
招募中
2 期
A Randomized Study of ASTX727 With or Without Iadademstat in Advanced Myeloproliferative Neoplasms (MPNs)Secondary MyelofibrosisEssential ThrombocythemiaPolycythemia VeraPrimary MyelofibrosisNCT06661915National Cancer Institute (NCI)78
撤回
1 期
A Phase 1B/2A Trial of Combination of ASTX727 With ASTX029 in Acute Myeloid LeukemiaAcute Myeloid LeukemiaNCT06113289M.D. Anderson Cancer Center42
Unknown
2 期
Donor Stem Cell Transplant in Treating Patients With Mantle Cell LymphomaLymphomaNCT00720447Cancer Research UK25