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Autologous Versus Allogeneic Hematopoietic Stem Cell Transplantation for T-Lymphoblastic Leukemia/Lymphoma in First Complete Remission

2026年5月10日 更新者：Xianmin Song, MD、Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
To evaluate, through a prospective multicenter observational study, autologous or allogeneic hematopoietic stem cell transplantation (Auto-SCT/allo-SCT)as consolidation therapy in subjects with T lymphoblastic leukemia/Lymphoblastic lymphoma(T-ALL/LBL)who have achieved first complete remission (CR). Assess relapse-free survival (RFS), overall survival (OS), cumulative incidence of relapse (CIR), and non-relapse mortality (NRM) among different treatment regimens

研究概览

地位

尚未招聘

条件

干预/治疗

详细说明

This prospective, multicenter cohort study enrolls patients with T-lymphoblastic leukemia/lymphoma in first complete remission (CR1) to investigate the efficacy and safety of autologous versus allogeneic hematopoietic stem cell transplantation as consolidation therapy. At screening/baseline, informed consent is obtained and inclusion/exclusion criteria are checked. The planned enrollment is 84 patients per group. Data collection includes demographics, medical history, vital signs, physical examination, laboratory tests (cranial MRI with contrast, PET-CT, routine blood and urine tests, liver and kidney function, routine CSF analysis, biochemistry, abnormal cells), pregnancy tests for female patients, and other necessary auxiliary examinations.

研究类型

观察性的

注册 (估计的)

84

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 孩子
  • 成人

接受健康志愿者

不

取样方法

非概率样本

研究人群

T-ALL/LBL patients in first complete remission

描述

  • Inclusion Criteria:
  • Age 14-55 years, no gender restriction
  • Expected survival >12 weeks
  • ECOG performance status 0-2
  • Pathologically or by bone marrow flow cytometry confirmed •T-lymphoblastic lymphoma in first complete remission (CR1) after chemotherapy; CR1 criteria: first complete remission, defined as: ① For intramedullary disease, meeting the CR criteria of the 2024 Chinese Adult Acute Lymphblastic Leukemia Diagnosis and Treatment Guidelines (2024 edition) with flow cytometric/gene testing showing MRD negativity; ② For extramedullary disease, meeting the Lugano 2014 response criteria for CR with a PET-CT score of 1-2

  • Hepatic, renal, cardiac, and pulmonary function meeting the following requirements:

    1. Creatinine clearance (by Cockcroft-Gault formula) ≥60 mL/min
    2. Cardiac ejection fraction >50%, with no clinically significant ECG abnormalities
    3. Baseline oxygen saturation >92%
    4. Total bilirubin ≤1.5×ULN; ALT and AST ≤3×ULN
  • Ability to understand the trial and signed informed consent
  • Exclusion Criteria:
  • Malignancies other than acute T-lymphoblastic leukemia, T-cell lymphoma, or T-lymphoblastic lymphoma within 5 years prior to screening, except for adequately treated cervical carcinoma in situ, basal cell or squamous cell skin cancer, localized prostate cancer after radical surgery, ductal carcinoma in situ after radical surgery, or thyroid cancer after radical surgery.
  • Active, uncontrolled bacterial, viral, or fungal diseases requiring treatment; HBsAg or HBcAb positive with peripheral blood HBV DNA ≥ lower limit of detection; HCV antibody positive with peripheral blood HCV RNA positive; positive TRUST test for syphilis; positive HIV antibody.
  • Dysfunction of vital organs (cardiovascular, cerebrovascular, pulmonary);history of active gastrointestinal bleeding within the past 3 months; uncontrolled hypertension or history of hypertensive crisis or hypertensive encephalopathy; history or evidence of major cardiovascular risk, including any of the following: congestive heart failure, unstable angina, clinically significant arrhythmias (e.g., ventricular fibrillation, ventricular tachycardia); history of arterial thrombosis within the past 3 months (e.g., stroke, transient ischemic attack); history of symptomatic deep vein thrombosis or pulmonary embolism within the past 6 months, or history of coronary angioplasty, defibrillation, or any clinically relevant complication or disease that may pose a risk to subject safety or interfere with study assessments, procedures, or completion.
  • Any other uncontrolled active disease that precludes participation in the trial.
  • Active, uncontrolled central nervous system involvement, or subjects with a history of CNS disease requiring treatment (e.g., epilepsy patients).
  • Pregnant or breastfeeding women; subjects planning to become pregnant within 1 year after infusion, or during or after treatment.
  • Presence of uncontrolled active infection (excluding simple urinary tract infection or upper respiratory tract infection).
  • Known allergy to conditioning regimen drugs.
  • Any condition that, in the investigator's judgment, would compromise subject safety or interfere with study objectives, or subjects deemed unsuitable for participation in this trial; subjects with illnesses affecting their ability to give written informed consent or to comply with study procedures; unwilling or unable to comply with study requirements

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

队列和干预

团体/队列
干预/治疗
Autologous stem cell transplantation group
T-ALL/LBL patients undergoing auto-SCT in CR1
程序：different stem cell transplantation type
cohort study
Allogeneic stem cell transplantation group
T-ALL/LBL patients undergoing allo-SCT in CR1
程序：different stem cell transplantation type
cohort study

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Relapse free survival
大体时间：24 months
Relapse free survival
24 months

次要结果测量

结果测量
措施说明
大体时间
操作系统
大体时间：12个月
总生存期
12个月
操作系统
大体时间：24个月
总生存期
24个月
RFS
大体时间：12 months
relapse free survival
12 months
CIR
大体时间：12 months
Cumulative incidence of relapse
12 months
CIR
大体时间：24 MONTHS
Cumulative incidence of relapse
24 MONTHS
NRM
大体时间：12 months
non-relapse mortality
12 months
NRM
大体时间：24 months
non-relapse mortality
24 months
CI of aGVHD
大体时间：180 days
Cumulative incidence of acute graft-versus-host disease (acute GVHD) for patients undergoing allo-SCT
180 days
CI of cGVHD
大体时间：12 months
Cumulative incidence of chronic graft-versus-host disease (chronic GVHD) after autologous versus allogeneic hematopoietic stem cell transplantation
12 months
CI of cGVHD
大体时间：24 months
Cumulative incidence of chronic graft-versus-host disease (chronic GVHD) after autologous versus allogeneic hematopoietic stem cell transplantation
24 months
Graft failure rate
大体时间：28 days after allo-SCT
Graft failure rate
28 days after allo-SCT

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年5月5日

初级完成 (估计的)

2029年5月5日

研究完成 (估计的)

2029年5月5日

研究注册日期

首次提交

2026年5月4日

首先提交符合 QC 标准的

2026年5月4日

首次发布 (实际的)

2026年5月11日

研究记录更新

最后更新发布 (实际的)

2026年5月13日

上次提交的符合 QC 标准的更新

2026年5月10日

最后验证

2026年5月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • SHSYXY-T-LBL-SCT-2025

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

未定

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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