NCT05009719已完成1 期
Study of the Efficacy and Safety of Risk-adapted Donor Lymphocyte Infusions for the Prophylaxis and Prevention of Relapses After Allogeneic Hematopoietic Stem Cell Transplantation in Children and Adolescent With Hematologic Malignancy
St. Petersburg State Pavlov Medical University2 个研究点 分布在 2 个国家目标入组 50 人开始时间: 2021年4月1日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Relapse - free survival
研究概览
简要总结
Allo-hsct is potentially curative method of treatment for children and adolescent with hematologic malignancy. However, relapses of disease after allo-hsct occur up to 50% of patients and constitute the main cause of mortality after HSCT. Donor lymphocytes infusion (DLI) is a form of immunotherapy based on developement of reaction "graft versus from leukemia". This study evaluates the safety and efficacy of risk-adapted srtategy of DLI for prophylaxis and prevention posttransplant relapses in children and adolescent with hematologic malignancy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 4 Months 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 4 months - 18 years old
- •Diagnosis: acute lymphoblastic leukemia, acute myeloid leukemia, juvenile myelomonocytic leukemia, myelodysplastic syndrome, chronic myeloid leukemia
- •Signed by legal representatives informed consent
- •High risk disease ( for ALL - initial hyperleukocytosis> 50x109 / L, T-cell ALL, hypodiploid karyotype, complex karyotype, MLL gene rearrangement, SIL-TAL deletion, primary resistent of the disease, early/very earle relapse, infant ALL; for AML patients - rearrangement of the MLL gene (except for t (1; 11) and t (9; 11) with M5 morphology), inv (3), t (3; 3), complex karyotype anomalies, t (8; 21 ) with trisomy 4, t (16; 21), monosomy 7, monosomy 5, M7 without t (1; 22), FLT3+, M6, t (7; 12), AML with multilineage dysplasia, p53 gene mutations, NUP98 translocations, primary resistent of the disease, early/very earle relapse infant AML, secondary AML; all juvenile myelomonocytic leukemia and myelodysplastic syndrome; allo-HSCT at 3 or more remission; persistence MRD before alloHSCT; allo-HSCT out of remission; persistence MRD after alloHSCT; cytogenetic relapse after alloHSCT )
- •Donor chimerism=>95%
- •No poor graft function (haemoglobin concentration < 100 g/L; neutrophils < 1.0 × 10E + 9/L; and platelets < 30 × 10E + 9/L on day ≥ 30 post transplant with complete donor chimerism and no graft-versus-host disease or relapse )
- •ECOG 0-2 status
- •Karnofsky/Lansky status >30%
排除标准
- •Uncontrolled bacterial or fungal infection at the time of enrollment
- •Severe organ failure: creatinine more than 2 norms; ALT, AST more than 5 norms; bilirubin more than 1.5 norms
- •Ejection fraction less than 50%
- •Requirement for vasopressor support at the time of enrollment
- •Somatic or psychiatric disorder making the patient unable to sign an informed consent
- •Acute GVHD grade 3-4 in patient medical history
- •Severe chronic GVHD in patient medical history
结局指标
主要结局
Relapse - free survival
时间窗: 24 months
Estimate time to morphological relapse by Kaplan Mayer
次要结局
- Relapse rate analysis(24 months)
- Incidence of acute GVHD grade II-IV(125 days)
- Graft - versus -host-disease free/relapse free survival(24 months)
- Incidence of moderate and severe chronic GVHD(24 months)
- Relapse - free survival(24 months)
- Non-relapse mortality analysis(24 months)
- Overall survival analysis(24 months)
- Incidence of achievement MRD negative status(24 months)
研究者
Ivan S Moiseev
Vice-director for science RM Gorbacheva Institute
St. Petersburg State Pavlov Medical University
研究点 (2)
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