NCT03291353撤回早期 1 期
Phase 0- Pilot Study of Pembrolizumab on Immune Cells in Patient With Refractory Acute Myeloid Leukemia
Michael Boyiadzis1 个研究点 分布在 1 个国家开始时间: 2017年10月17日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 早期 1 期
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- Adverse event assessment
研究概览
简要总结
This is an open label, single-arm, pilot trial to evaluate the immune effects, safety and tolerability of pembrolizumab in subjects newly diagnosed with acute myeloid leukemia (AML) who have persistent leukemia after induction chemotherapy. Patients must have an ECOG performance status of 0-1. The enrollment target for this study is 10 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Be willing and able to provide written informed consent/assent for the trial.
- •Be 18 years of age on the day of signing informed consent.
- •Patients with newly diagnosed AML based on the World Health Organization classification (21) who have persistent leukemia after a course or more of treatment with induction chemotherapy (the diagnosis of persistent disease, which is defined as >10% blasts by evaluation of bone marrow biopsy or bone marrow aspirate).
- •Left ventricular ejection fraction (LVEF) ≥ 45%
- •Have a performance status of 0 or 1 on the ECOG Performance Scale.
- •Demonstrate adequate organ function, all screening labs should be performed within 10 days of treatment initiation.
- •Female subject of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
- •Female subjects of childbearing potential must be willing to use an adequate method of contraception- Contraception, for the course of the study through 120 days after the last dose of study medication.
- •Male subjects of childbearing potential must agree to use an adequate method of contraception- Contraception, starting with the first dose of study therapy through 120 days after the last dose of study therapy.
排除标准
- •Has a diagnosis of Acute Promyelocytic Leukemia (APL) as defined by the World Health Organization
- •Relapsed acute myeloid leukemia
- •Bi-lineage or bi-phenotypic leukemias
- •Prior use of clofarabine or fludarabine
- •Previous allogeneic or autologous hematopoietic cell transplantation or solid organ transplantation
- •Is currently participating in and receiving study therapy, or has participated in a study of an investigational agent and received study therapy, or used an investigational device within 4 weeks of the first dose of treatment.
- •Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment.
- •Has a known history of active TB (Bacillus Tuberculosis)
- •Hypersensitivity to pembrolizumab or any of its excipients.
- •Has had a prior anti-cancer monoclonal antibody (mAb) within 4 weeks prior to study Day 1 or who has not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to agents administered more than 4 weeks earlier.
- •Has had prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to study Day 1 or who has not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to a previously administered agent.
- •Concurrent active malignancy; exceptions include patients who have been disease free for 5 years, patients with a history of completely resected non-melanoma skin cancer or successfully treated in situ carcinoma, or patients with another malignancy that is indolent or definitively treated.
- •Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis and/or has known active central nervous system (CNS) leukemia involvement.
- •Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (eg., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.
- •Has a history of (non-infectious) pneumonitis that required steroids or current pneumonitis.
- •Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.
- •Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
- •Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the pre-screening or screening visit through 120 days after the last dose of trial treatment.
- •Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent.
- •Has a known history of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies).
- •Has known active Hepatitis B or Hepatitis C.
- •Has received a live vaccine within 30 days of planned start of study therapy.
研究组 & 干预措施
AML Patients
Experimental
pembrolizumab 200 mg given IV once every three weeks
干预措施: pembrolizumab (Drug)
结局指标
主要结局
Adverse event assessment
时间窗: From prior to first dose up to 48 months
Adverse event assessment using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
次要结局
- Response Rate (RR)(Up to greater than or equal to 48 months)
- Overall survival(Up to greater than or equal to 48 months)
研究者
Michael Boyiadzis
Associate Professor of Medicine
University of Pittsburgh
研究点 (1)
Loading locations...
相似试验
已完成
2 期
Azacitidine and Pembrolizumab in Pancreatic CancerPancreas CancerNCT03264404Susan E. Bates36
进行中（未招募）
2 期
Study of Pembrolizumab, Binimetinib, and Bevacizumab in Patients With Refractory Colorectal CancerMetastatic CancerColorectal CancerNCT03475004University of Colorado, Denver53
招募中
2 期
Pembrolizumab in Treating Participants With LeukoplakiaErythroleukoplakiaLeukoplakiaVerrucous Oral LeukoplakiaNCT03603223Jonsson Comprehensive Cancer Center26
进行中（未招募）
早期 1 期
Pembrolizumab Plus Y90 Radioembolization in HCC SubjectsHepatocellular CarcinomaNCT03099564Ashwin Somasundaram30
已完成
1 期
CMP-001 for Relapsed and Refractory LymphomaLymphomaNCT03983668Umar Farooq14