NCT03365661撤回2 期
QUILT-3.034: Multi-Center Trial of Non-Myeloablative TCRa/b Deplete Haploidentical Hematopoietic Cell Transplantation With Post HCT ALT-803 in High-Risk Myeloid Diseases
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Incidence of disease response
研究概览
简要总结
This is a phase II multi-institutional therapeutic study of a non-myeloablative T cell receptor (TCR) alpha/beta depleted haploidentical transplantation with post-transplant immune reconstitution using ALT-803 for the treatment of high-risk myeloid leukemia (AML), treatment-related/secondary AML, and myelodysplastic syndrome (MDS).
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
- •Age ≥18 to ≤70 years
- •Meets one of the following disease and risk categories:
- •High-Risk Acute Myeloid Leukemia (AML) with predicted risk of relapse higher than 30%, which includes, but not limited to the following:
- •Patients in morphological remission (CR1 or beyond) with minimal residual disease as quantified either by flow cytometry, or by cytogenetics or molecular markers.
- •Patients with the following karyotypes in morphological CR or CRi: ELN-Intermediate I, Adverse, ELN-Intermediate-II. (18) (Examples include monosomal karyotype, complex karyotype, mutant p53, mutant RUNX1, mutant ASXL1, mutant FLT3-ITD, mutant DNMT3A, Inversion 3, T(6:9), KIT mutated core binding factor AML)
- •Treatment-Related AML and Secondary AML in morphological remission (CR1 or beyond) with minimal residual disease as quantified either by flow cytometry, or by cytogenetics or molecular markers
- •Myelodysplastic Syndrome (MDS) with < 5% blasts by morphology and meets at least one of the following:
- •Received intensive induction chemotherapy (i.e. 7+3 or MEC) OR
- •Progression after 4 cycles of hypomethylating agents
- •The donor and recipient must be HLA identical for at least one haplotype (using high resolution DNA based typing) at the following genetic loci: HLA-A, HLA-B, HLA-C, and HLA-DRB1
- •Karnofsky performance status ≥ 60% (appendix IV)
- •Adequate organ function within 14 days of study registration (30 days for pulmonary and cardiac) defined as:
- •Hepatic: AST and ALT < 3 x upper limit of institutional normal
- •Renal: estimated glomerular filtration rate (GFR) ≥ 40 mL/min/1.73m2
- •Pulmonary: oxygen saturation ≥ 90% on room air with no symptomatic pulmonary disease. If symptomatic or prior known impairment DLCOcor ≥ 40%.
- •Cardiac: LVEF ≥ 40% by echocardiography, MUGA, or cardiac MRI, no uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities
- •Able to be off prednisone or other immunosuppressive medications for at least 3 days prior to transplant (excluding preparative regimen pre-medications)
- •Sexually active females of child bearing potential and males with partners of child bearing potential must agree to use effective contraception during therapy and for 4 months after completion of therapy
- •Voluntary written consent prior to the performance of any research related procedures
排除标准
- •Acute leukemias of ambiguous lineage
- •Allogeneic transplant for AML within the previous 6 months (no time limit for autologous transplant)
- •Active CNS disease - if a history of AML related CNS involvement, screening CSF analysis must be negative
- •Pregnant or breastfeeding - The agents used in this study include those that fall under Pregnancy Category D - have known teratogenic potential. Women of child bearing potential must have a negative pregnancy test at screening
- •Active autoimmune disease requiring systemic immunosuppressive therapy
- •History of severe asthma and currently on systemic chronic medications (mild asthma requiring inhaled steroids only is eligible)
- •New or progressive pulmonary infiltrates on screening chest x-ray or chest CT scan unless cleared for study by Pulmonary. Infiltrates attributed to infection must be stable/improving (with associated clinical improvement) after 1 week of appropriate therapy (4 weeks for presumed or documented fungal infections).
- •Uncontrolled bacterial, fungal or viral infections including HIV-1/2 or active hepatitis C/B - chronic asymptomatic viral hepatitis is allowed
- •Active concomitant second malignancy (i.e. has required treatment in the previous 6 months)
- •Known hypersensitivity to any of the study agents
- •Received any investigational drugs within the 14 days before 1st dose of fludarabine
研究组 & 干预措施
ALT-803
Experimental
干预措施: ALT-803 (Biological)
结局指标
主要结局
Incidence of disease response
时间窗: Day 28
Rate of donor neutrophil engraftment in the absence of disease at Day +28. Neutrophil engraftment is defined as absolute neutrophil count (ANC) ≥ 5 X 10 8 /L.
次要结局
- Disease Free Survival (DFS)(12 months)
- Treatment Related Mortality (TRM)(12 months)
- Disease Relapse(12 months)
- Grade II-IV acute Graft versus Host Disease (aGVHD)(Day 100)
- Serious Adverse Events from ALT-803 (Early Schedule)(1 Year)
- Serious Adverse Events from ALT-803 (Late Schedule)(1 Year)
- Chronic Graft versus Host Disease (cGVHD)(1 year)
研究者
研究点 (2)
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