JPRN-jRCTs041190061进行中（未招募）2 期
Multicenter, single-group, open-label study of T-cell-replete haploidentical stem cell transplantation for relapsed and refractory childhood acute leukemia with low dose anti-thymocyte immunoglobulin - Haplo-SCT16
Kobayashi Shogo0 个研究点目标入组 38 人开始时间: 2019年8月13日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 38
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
- >= 至 < 20age old（—）
- 性别
- All
入选标准
- •(1) Childhood Acute Leukemia Patient at the Time of Initial Age 0 to under 18 and under the age of 20 when registering
- •(2) It is a relapsed / refractory case having one of the following stages
- •(2-1) non-remission for the first two or more different induction therapies
- •(2-2) extremely early and early relapsed ALL (corresponding to BFM recurrence risk classification S3, 4) within 6 months after treatment, during treatment,
- •(2-3) Recurrence AML less than 1 year after treatment start
- •(2-4) Relapse after transplantation (including autologous, syngeneic, allogeneic transplantation, haploidentical transplantation)
- •(2-5) Second recurrence or more
- •(3) HLA haploidentical transplant donors are present
- •(4) ECOG Performance status (PS) 0 - 3
- •(5) Patients enrolled for JPLSG's forward vision study (JPLSG-CHM-14)
- •(6) Patients who agreed in writing (including ascent) from the principal and / or substitute for this study participation
排除标准
- •(1) Relapsed leukemia patients with extramedullary invasion only (eg central nervous invasion only)
- •(2) Ph1 positive acute leukemia patients who have never received treatment with tyrosine kinase inhibitor (TKI)
- •(3) There is a merger of congenital chromosomal abnormality syndrome such as Down's syndrome
- •(4) There is an organ failure that interferes with examination treatment
- •(4-1) Renal function: serum creatinine value is less than twice as high as the age-specific upper limit
- •(4-2) cardiac function: heart failure requiring treatment and arrhythmia. Or less than 50% EF or less than 28% SF
- •(4-3) Liver function: AST / ALT is at least 5 times higher than age-specific reference value upper limit (CTCAE grade 3 or more) and T-Bil is at least 3 times higher than age-specific reference value upper limit (CTCAE grade 3 or more)
- •(4-4) Respiratory function: There is a breathing disorder that is less than 95% SpO 2 in room air or requires oxygen administration
- •(5) Patients who have an uncontrolled infection (including active tuberculosis, HIV infection)
- •(6) Patients who are pregnant or possibility of pregnancy
- •(7) Have congenital or psychiatric disorders that interfere with study treatment
- •(8) Secondary cancers other than recurrent hematopoietic tumors are merged
- •(9) Patients received two or more myeloablative conditioning allogeneic transplantation in the past
- •(10) Secondary leukemia
- •(11) myeloid NK cell leukemia
- •(12) There is a history of hypersensitivity in drugs used for pretransplant treatment and prevention of acute GVHD
- •(13) Any inappropriate status judged by physician
研究者
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