JPRN-jRCTs051180190招募中2 期
Phase II study of allogeneic hematopoietic cell transplantation for children with acute myeloid leukemia in first and second complete remission using fludarabine, cytarabine, melphalan and low-dose total body irradiation as a conditioning regimen (AML-SCT15). - AML-SCT15
YABE Hiromasa0 个研究点目标入组 66 人开始时间: 2019年3月26日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 66
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
- ot applicable 至 < 20age old（—）
- 性别
- All
入选标准
- •Inclusion criteria
- •1)AML (acute promyelocytic leukemia, AML which developed in patients with Down syndrome, secondary AML, AML which developed in patients with myelodysplastic syndrome, NK/myeloid leukemia and granulocytic leukemia are excluded)
- •2)Cases registered in the prospective study in JPLSG (JPLSG CHM-14)
- •3)Patients with high-risk AML in first complete remission or bone marrow-relapsed patients with AML in second complete remission
- •4)High-risk AML
- •Any of the following
- •a)Unfavorable chromosome abnormality including -7, del(5q)/-5, t(16;21)(p11;q22)/FUS-ERG, t(9;22)(q34;q11.2)/BCR-ABL1 or t(6;11)(q27;q23)/MLL-MLLT4(AF6), or unfavorable genetic abnormality including FLT3-ITD or NUP98-NSD1
- •b)Blast ratio >=5% in the bone marrow (M2/M3 marrow) after the first induction therapy
- •c)Extramedullary lesions after the first induction therapy
- •5)Patients less than 18 years at the initial diagnosis in first remission, or patients less than 20 years at the relapse diagnosis in second remission
- •6)Written informed consent has been acquired from patients and/or persons with parental authority.
- •7)Cases in which a suitable donor is available and hematopoietic cell transplantation is considered to be mandatory
- •8)Patients whose performance status are 0 or 2 by ECOG criteria
- •9)Patients who satisfactory meet all of the following criteria about organ functions within 28 days prior to registration
- •a)Patients without uncontrolled cardiac failure and ejection fraction of left ventricle >= 50% by UCG
- •b)%VC >= 50% and FEV1.0% >= 50%, or SpO2 >= 95% by room air if pulmonary function tests are impossible
- •c)AST/ALT < 5 x upper limit of normal range (CTCAE < grade 2)
- •d)Patients without uncontrolled renal failure and sCr < 2 x upper limit of normal range
排除标准
- •Exclusion criteria
- •1)Patients who have extramedullary lesions at registry
- •2)Patients who have prior radiation therapy
- •3)Patients who have prior hematopoietic cell transplantation
- •4)Patients who have poorly controlled infectious disease
- •5)Patients who have psychiatric disorder
- •6)Patients who have coinciding malignancies
- •7)Patients who have an episode of hypersensitivity reactions against drugs used in conditioning regimens and/or GVHD prophylaxis
- •8)Pregnant women or women who may be pregnant
- •9)Patients who are considered as inappropriate for this trial by attending physicians
研究者
相似试验
招募中
2 期
Phase II study of allogeneic hematopoietic cell transplantation for children with acute myeloid leukemia in first and second complete remission using fludarabine, cytarabine, melphalan and low-dose total body irradiation as a conditioning regimen (AML-SCT15).acute myeloid leukemia (AML)JPRN-UMIN000027821Japan Children's Cancer Group (JCCG)66
已完成
2 期
Phase II study of allogeneic hematopoietic stem cell transplantation for patients with myeloid malignancies using once daily intravenous busulfan and fludarabine as conditioning regimeacute myeloid leukemia(AML) myelodysplastic syndrome(MDS) chronic myelogenous leukemia(CML)JPRN-UMIN000009766Hematopoietic Stem Cell Transplantation Division, National Cancer Center Hospital75
招募中
2 期
Phase II study of allogeneic hematopoietic stem cell transplantation using a preparative regimens consisting of iv Bu + Flu + L-PAM for patients with juvenile myelomonocytic leukemia (JMML)Juvenile myelomonocytic leukemia (JMML)JPRN-UMIN000005936Japanese Pediatric Leukemia/Lymphoma Study Group (JPLSG)43
已完成
2 期
A phase II study of allogeneic hematopoietic stem cell transplantation for patients with myeloid malignancies using intravenous busulfan and cyclophosphamide as conditioning regimen.CML(chronic myelogenous leukemia) AML(acute myeloid leukemia) MDS(myelodysplastic syndrome)JPRN-UMIN000003648Kanto Study Group for Cell Therapy Nagoya Blood and Marrow Transplantation (NBMT) Group40
已完成
2 期
Randomized phase II study of allogeneic hematopoietic stem cell transplantation for patients with myeloid malignancies using once daily intravenous busulfan and cyclophosphamide as conditioning regimeacute myeloid leukemia(AML) myelodysplastic syndrome(MDS) chronic myelogenous leukemia(CML)JPRN-UMIN000009762Hematopoietic Stem Cell Transplantation Division, National Cancer Center Hospital68