NCT06337331撤回2 期
A Phase II Trial of Venetoclax-Enhanced Reduced Intensity HLA-Mismatched Allogeneic Transplant for Ultra-High-Risk Acute Myeloid Leukemia (AML) and Myelodysplastic Syndrome (MDS)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Incidence of relapse/progression by conducting blood and bone marrow biopsy evaluations at one-year post-transplant
研究概览
简要总结
Patients eligible for a mismatch allogeneic stem cell transplant will receive Venetoclax daily for 7 days prior to transplant in addition to the following chemotherapy regimen: Decitabine daily for 5 days, Fludarabine daily for 5 days, and Busulfan daily for 2 days followed by 1 day of total body irradiation. Stem cell transplant will occur thereafter.
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
- •Availability of a 4/8 - 6/8 HLA-matched related donor or a 7/8 HLA-matched unrelated donor
- •Receiving first allogeneic transplant
- •KPS >/= 70%
- •MDS associated with TP53 mutation AND R-IPSS high or very high risk at diagnosis OR
- •AML with adverse risk cytogenetics or molecular abnormalities according to the 2017 ELN risk stratification OR pre-transplant MRD by either flow cytometry, cytogenetics or FISH
- •Less than 5% myeloblasts in the marrow pre-transplant
排除标准
- •Poor cardiac function defined as LVEF <45%
- •Poor pulmonary function defined as FEV1, FVC, or DLCO <50% predicted
- •Poor liver function defined as bilirubin >/=2.5mg/dL, AST/ALT >3xULN
- •Poor renal function defined as creatinine >/=2.0mg/dL or CrCl <40mL/min
- •Ongoing or active systemic infection, active Hepatitis B or C virus infection, or known HIV positivity
- •Patient requiring treatment with a moderate or strong inhibitor or inducer of CYP3A4 or a P-gp inhibitor within 7 days prior to starting preparative chemotherapy through Day +4 post-transplant
研究组 & 干预措施
High-dose Chemotherapy + Mismatched Allogeneic Stem Cell Transplant
Experimental
干预措施: Venetoclax (Drug)
High-dose Chemotherapy + Mismatched Allogeneic Stem Cell Transplant
Experimental
干预措施: Decitabine (Drug)
High-dose Chemotherapy + Mismatched Allogeneic Stem Cell Transplant
Experimental
干预措施: Fludarabine (Drug)
High-dose Chemotherapy + Mismatched Allogeneic Stem Cell Transplant
Experimental
干预措施: Busulfan (Drug)
High-dose Chemotherapy + Mismatched Allogeneic Stem Cell Transplant
Experimental
干预措施: Total Body Irradiation (Radiation)
结局指标
主要结局
Incidence of relapse/progression by conducting blood and bone marrow biopsy evaluations at one-year post-transplant
时间窗: 12 months
次要结局
- Number of patients who fully engrafted (blood counts fully recovered) by conducting chimerism studies at 30-, 60-, 90-, 180-, and 365-days post transplant(12 months)
- Number of patients who developed acute graft-versus-host disease by recording signs and symptoms of acute GVHD according to MAGIC standards at one-year post-transplant(12 months)
- Number of patients alive at one-year post transplant(12 months)
- Number of patients who developed chronic graft-versus-host disease by recording signs and symptoms of chronic GVHD according to NIH standards at one-year post-transplant(12 months)
- Number of patients who died one year post-transplant not related to recurrence of disease(12 months)
- Number of patients who are alive at one-year post transplant who also did not develop GVHD(12 months)
- Number of patients alive without recurrence of disease at one-year post transplant by conducting blood and bone marrow biopsy procedures(12 months)
- Number of patients with treatment-related adverse events to venetoclax as assessed by CTCAE v5.0(12 months)
研究者
研究点 (1)
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