A Randomized Study of Haploidentical Lymphocytes With Nivolumab and Intermediate Dose Cytarabine Versus Nivolumab and Intermediate Dose Cytarabine as Consolidation Treatment in Older Adults With Acute Myeloid Leukemia.
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Disease-free survival
研究概览
简要总结
A phase II trial to compare the efficacy and safety of nivolumab and intermediate dose cytarabine with or without haploidentical lymphocyte infusion. To identify the role of haploidentical lymphocytes in the treatment of acute myeloid leukemia in older adults. The patients will be stratified based on the remission number (first or second)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 55 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with a diagnosis of acute myeloid leukemia with the confirmed first or second complete remission
- •≥ 55 years of age
- •Not candidates for allogeneic stem cell transplantation as decided by the panel of hematologists at the transplant center
- •Patients with a HLA-haploidentical donor who should be able to provide informed consent for peripheral blood apheresis
- •No severe concurrent illness that limits life expectancy to less than 2 years
排除标准
- •Uncontrolled bacterial or fungal infection at the time of enrollment
- •Karnofsky index <70%
- •Acute promyelocytic leukemia
- •Other tumor requiring treatment at the time of enrollment
- •Active or prior documented autoimmune disease requiring systemic treatment
- •Somatic or psychiatric disorder making the patient unable to sign informed consent
研究组 & 干预措施
Ara-C+HaploLymphocyte+Nivo
Patients treated with nivolumab, intermediate dose cytarabine and haploidentical lymphocyte infusion:
[Cytarabine 500-1000 mg/m2 bid D-4, -3, -2 + G-CSF mobilized HLA-haploidentical donor peripheral blood stem cells infusion D0
- Nivolumab 40 mg D+5] х 2-3 cycles
干预措施: Cytarabine (Drug)
Ara-C+HaploLymphocyte+Nivo
Patients treated with nivolumab, intermediate dose cytarabine and haploidentical lymphocyte infusion:
[Cytarabine 500-1000 mg/m2 bid D-4, -3, -2 + G-CSF mobilized HLA-haploidentical donor peripheral blood stem cells infusion D0
- Nivolumab 40 mg D+5] х 2-3 cycles
干预措施: Nivolumab (Drug)
Ara-C+HaploLymphocyte+Nivo
Patients treated with nivolumab, intermediate dose cytarabine and haploidentical lymphocyte infusion:
[Cytarabine 500-1000 mg/m2 bid D-4, -3, -2 + G-CSF mobilized HLA-haploidentical donor peripheral blood stem cells infusion D0
- Nivolumab 40 mg D+5] х 2-3 cycles
干预措施: G-CSF mobilized HLA-haploidentical donor PBSC (Biological)
Ara-C+ Nivo
Patients treated with nivolumab and intermediate dose cytarabine:
[Cytarabine 500-1000 mg/m2 bid D+1, +2, +3 + Nivolumab 40 mg D+1] х 2-3 cycles
干预措施: Cytarabine (Drug)
Ara-C+ Nivo
Patients treated with nivolumab and intermediate dose cytarabine:
[Cytarabine 500-1000 mg/m2 bid D+1, +2, +3 + Nivolumab 40 mg D+1] х 2-3 cycles
干预措施: Nivolumab (Drug)
结局指标
主要结局
Disease-free survival
时间窗: 2 years
DFS will be assessed with Kaplan-Meier method from the date of last remission before randomization until the date of relapse or the date of death
次要结局
- Incidence of graft-versus-host disease(up to 12 months)
- Treatment-related adverse events as assessed by CTCAE v4.03(up to 12 months)
- Overall survival(2 years)
研究者
Ivan S Moiseev
Vice-director for science of R.M. Gorbacheva Memorial Institute of Hematology, Oncology and Transplantation
St. Petersburg State Pavlov Medical University