NCT03050216已完成2 期
QUILT-3.033: Haploidentical Donor Natural Killer (NK) Cell Infusion With Subcutaneous ALT-803 in Adults With Refractory or Relapsed Acute Myelogenous Leukemia
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 8
- 试验地点
- 2
- 主要终点
- Number of Participants With Complete Remission With or Without Incomplete Platelet Recovery
研究概览
简要总结
This is a multi-institutional Simon's optimal two-stage phase II trial of CD3/CD19 depleted, ALT-803 activated, haploidentical donor NK cells and subcutaneous ALT-803 given after lymphodepleting chemotherapy (CY/FLU) for the treatment of refractory or released acute myelogenous leukemia (AML).
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
- 是
入选标准
- •Diagnosis of acute myeloid leukemia (AML) and meets one of the following disease criteria:
- •Primary induction failure:
- •De novo AML - no CR after 2 or more chemotherapy induction attempts
- •Secondary AML (from MDS or treatment related): no CR after 1 or more chemotherapy induction attempts
- •Relapse after chemotherapy: not in CR after 1, 2, or 3 re-induction attempts
- •Patients > 60 years of age, the 1 cycle of chemotherapy is not required
- •Relapse after hematopoietic stem cell transplant:
- •Relapse must have occurred > 18 months after transplant
- •No re-induction required and no more than 1 re-induction attempt is allowed
- •For hypomethylating agents (i.e. decitabine, azacitidine) to count as an induction/re-induction attempt, the patient must have completed a minimum of 3 monthly cycles
- •For targeting agents (i.e. sorafenib) to count as an induction/re-induction attempt, the patient must have completed a minimum of 1 month without attaining CR
- •7+3 followed by 5+2 counts as TWO induction attempts
- •Use of hydroxyurea is permitted to control blasts until Day -3 per Section 8.7
- •A history of AML related CNS involvement is allowed if CSF analysis is negative on 2 test dates at least 2 weeks apart prior to study treatment. The use of ongoing CNS maintenance therapy is allowed while on study.
- •HLA-haploidentical related donor (aged 12 to 75 years) with donor/recipient match based on a minimum of intermediate resolution DNA based Class I typing of the A and B locus (at least 2/4 class I allele)
- •Karnofsky Performance Status ≥ 60%
- •Adequate organ function within 14 days of study registration (28 days for pulmonary and cardiac) defined as:
- •Creatinine: ≤ 2.0 mg/dL
- •Hepatic: AST and ALT < 3 x upper limit of institutional normal
- •Pulmonary Function: oxygen saturation ≥ 90% on room air; PFT's required only if symptomatic or prior known impairment - must have pulmonary function >50% corrected DLCO and FEV
- •Cardiac Function: 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 systemic immunosuppressive medications for at least 3 days prior to NK cell infusion (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
- •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
- •Received any investigational agent within the 14 days before the start of study treatment (1st dose of fludarabine)
- •Prior ALT-803
结局指标
主要结局
Number of Participants With Complete Remission With or Without Incomplete Platelet Recovery
时间窗: Day 42 post NK cell infusion
To estimate the rate of complete remission with incomplete platelet recovery (CRp) - defined as leukemic clearance and neutrophil recovery without platelet recovery - by day 42 after the infusion of CD3/CD19 depleted, ALT-803 stimulated, donor NK cells and subcutaneous ALT-803 given after a non-myeloablative preparative regimen for the treatment of refractory or released acute myelogenous leukemia (AML)
次要结局
- Incidence of in Vivo Expansion ≥100 of Donor Derived NK Cells Per /μl Blood(Day 14 post NK cell infusion)
- Number of Participants Experiencing ALT-803 Associated Toxicity(Day 10)
- Number of Participants With Treatment Related Mortality(6 months post-therapy)
研究者
研究点 (2)
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