Autologous Versus Allogeneic Hematopoietic Stem Cell Transplantation for T-Lymphoblastic Leukemia/Lymphoma in First Complete Remission
1 other identifier
observational
84
0 countries
N/A
Brief Summary
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started May 2026
Typical duration for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 4, 2026
CompletedStudy Start
First participant enrolled
May 5, 2026
CompletedFirst Posted
Study publicly available on registry
May 11, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 5, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 5, 2029
May 13, 2026
May 1, 2026
3 years
May 4, 2026
May 10, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Relapse free survival
Relapse free survival
24 months
Secondary Outcomes (11)
RFS
12 months
CIR
12 months
CIR
24 MONTHS
OS
12 months
OS
24 months
- +6 more secondary outcomes
Study Arms (2)
Autologous stem cell transplantation group
T-ALL/LBL patients undergoing auto-SCT in CR1
Allogeneic stem cell transplantation group
T-ALL/LBL patients undergoing allo-SCT in CR1
Interventions
cohort study
Eligibility Criteria
T-ALL/LBL patients in first complete remission
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 24 Months
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
May 4, 2026
First Posted
May 11, 2026
Study Start
May 5, 2026
Primary Completion (Estimated)
May 5, 2029
Study Completion (Estimated)
May 5, 2029
Last Updated
May 13, 2026
Record last verified: 2026-05