JPRN-jRCT2033200305进行中（未招募）2 期
A phase IIa study of aAVC-WT1 therapy to treat acute myeloid leukemia with MRD-positive complete remission or partial remission and high-risk myelodysplastic syndromes
Fujii Shinichiro0 个研究点目标入组 18 人开始时间: 2021年1月15日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 18
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 ot applicable（—）
- 性别
- All
入选标准
- •1.Ability to give patients' consent by written informed consent form
- •2.Age >= 20
- •3.AML with MRD-positive complete remission or partial remission and high-risk MDS by 2016 WHO classification
- •4.Awareness of AML or MDS
- •5.Peripheral blood WT-1 mRNA => 50 copies/microgram ever before
- •6.In patients with Hematological CR, one of the following 1) and 2) was observed :
- •1) Blood WT-1 mRNA => 50 copies/microgram
- •2) In the quantitative analysis of disease-specific mRNAs (one or more of RUNX1-RUNX1T1, DEK-NUP214, NUP98-HOXA9, CBFB-MYH11, KMT2A-MLLT3, KMT2A-AFDN) caused by chromosomal abnormalities using bone marrow or peripheral blood, disease-specific mRNAs => 50 copies/microgram.
- •7.ECOG Performance Status <= 2
- •8.Life expectancy >= 12 weeks
排除标准
- •1.Acute promyelocytic leukemia, BCR-ABL-positive leukemia
- •2.Central nervous system infiltration/extramedullary AML
- •3.Sustained non-hematological toxicity ( >= Grade 2) related to prior therapy for AML
- •4.Clinically relevant graft-versus-host disease required for treatment
- •5.Duration from prior therapy to administration:
- •1) Systemic immunosuppressive drugs including steroids <= 14 days
- •2) Investigational drugs, products, or medical devices <= 4 weeks
- •3) Hematopoietic stem cell transplantation <= 8 weeks
- •4) Chemotherapy (excluding hydroxyurea for leukemia control)
- •5) SARS-CoV-2 Vaccination within 2 weeks (Preferably for one month.)
- •(Do not administer aAVC-WT1 while the adverse event(s) persist, even after a patient cleared this criterion.)
- •6.Laboratory examination <= 14 days prior to registration:
- •1) AST/ALT >= 3 times upper limit of normal level (ULN)
- •2) Total serum bilirubin level >= 2 times ULN
- •3) Lymphocytes (peripheral blood) <= 5.0 x 10^2 /microliter
- •4) Estimated glomerular filtration rate < 30 mL/min
- •5) SpO2 < 94% (room air)
- •7.Other active malignancies
- •8.Angina pectoris, acute myocardial infarction, congestive heart failure (>= NYHA class 3), or severe abnormality on electrocardiography <= 12 weeks prior to 1st administration
- •9.Poor control hypertension, interstitial pneumonia, pulmonary fibrosis, chronic obstructive pulmonary disease (>= stage 3)
- •10.Disseminated intravascular coagulation
- •11.Active/poor control infection, HIV infection
- •12.Active hepatitis B/C virus infection, other active liver disease
- •13.Congenital/acquired immune deficiency
- •14.Pregnant, possible pregnant, breast feeding women
- •15.Poor control diabetes mellitus
- •16.Known hypersensitivity to reagents (human albumin, etc.), additives (galactose/ceramide), antibiotics (streptomycin/gentamicin) and heterologous proteins (fetal bovine serum/porcine trypsin)
- •17.Principal investigator/co-investigator judgement
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