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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age14-55
SponsorShanghai General Hospital, Shanghai Jiao Tong University School of Medicine

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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.

Trial population

T-ALL/LBL patients in first complete remission

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • different stem cell transplantation type

    Procedure/Surgery

    cohort study

Treatment groups

84 Participants
are divided into 2 treatment groups
Group A: Autologous stem cell transplantation group1 intervention
Group B: Allogeneic stem cell transplantation group1 intervention

Trial outcomes

Primary outcomes

1

Relapse free survival

Relapse free survival

Time frame
24 months

Secondary outcomes

1

RFS

relapse free survival

Time frame
12 months
2

CIR

Cumulative incidence of relapse

Time frame
12 months
3

CIR

Cumulative incidence of relapse

Time frame
24 MONTHS
4

OS

Overall survival

Time frame
12 months

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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