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

Обзор

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

Подробное описание

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.

Вмешательства

• Процедура different stem cell transplantation type
  cohort study

Первичные конечные точки

• Relapse free survival [Срок оценки: 24 months]

Вторичные конечные точки (11)

• RFS [Срок оценки: 12 months]
• CIR [Срок оценки: 12 months]
• CIR [Срок оценки: 24 MONTHS]
• OS [Срок оценки: 12 months]
• OS [Срок оценки: 24 months]
• NRM [Срок оценки: 12 months]
• NRM [Срок оценки: 24 months]
• CI of aGVHD [Срок оценки: 180 days]
• CI of cGVHD [Срок оценки: 12 months]
• CI of cGVHD [Срок оценки: 24 months]
• Graft failure rate [Срок оценки: 28 days after allo-SCT]

Критерии участия

• 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:

• Creatinine clearance (by Cockcroft-Gault formula) ≥60 mL/min
• Cardiac ejection fraction >50%, with no clinically significant ECG abnormalities
• Baseline oxygen saturation >92%
• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07577531 · SHSYXY-T-LBL-SCT-2025

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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