T Cell Acute Lymphoblastic Leukemia/Lymphoblastic LymphomaNCT07577531
Autologous Versus Allogeneic Hematopoietic Stem Cell Transplantation for T-Lymphoblastic Leukemia/Lymphoma in First Complete Remission
An observational study of T Cell Acute Lymphoblastic Leukemia/Lymphoblastic Lymphoma, run by Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine.
Trial 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). Read more about this study
- Who is it for?
- Ages 14 to 55 years
- Conditions the study is for
- T Cell Acute Lymphoblastic Leukemia/Lymphoblastic Lymphoma
- What is being tested?
- different stem cell transplantation type
- Type of treatment
- Surgery or procedure
- How many people
- 84 participants
- Where
- No sites listed yet
- Study dates
- 5 May 2026to 5 May 2029
- How long will I take part?
- 24 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 55 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: T-ALL/LBL patients in first complete remission
Who may be able to join
- 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
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- 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
Who cannot join
- 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.
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- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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
Read the detailed description
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.
- Being tested
- different stem cell transplantation type
- Medical subject headings
- Precursor T-Cell Lymphoblastic Leukemia-Lymphoma, Precursor Cell Lymphoblastic Leukemia-Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
different stem cell transplantation typeProcedure or surgery
cohort study
| Study group | Role | What they receive |
|---|---|---|
| Autologous stem cell transplantation group | T-ALL/LBL patients undergoing auto-SCT in CR1 Receives: Procedure: different stem cell transplantation type | |
| Allogeneic stem cell transplantation group | T-ALL/LBL patients undergoing allo-SCT in CR1 Receives: Procedure: different stem cell transplantation type |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relapse free survival
Relapse free survival
Measured: 24 months
Secondary outcomes (11)
RFS
relapse free survival
Measured: 12 months
CIR
Cumulative incidence of relapse
Measured: 12 months
CIR
Cumulative incidence of relapse
Measured: 24 MONTHS
OS
Overall survival
Measured: 12 months
OS
Overall survival
Measured: 24 months
NRM
non-relapse mortality
Measured: 12 months
NRM
non-relapse mortality
Measured: 24 months
CI of aGVHD
Cumulative incidence of acute graft-versus-host disease (acute GVHD) for patients undergoing allo-SCT
Measured: 180 days
CI of cGVHD
Cumulative incidence of chronic graft-versus-host disease (chronic GVHD) after autologous versus allogeneic hematopoietic stem cell transplantation
Measured: 12 months
CI of cGVHD
Cumulative incidence of chronic graft-versus-host disease (chronic GVHD) after autologous versus allogeneic hematopoietic stem cell transplantation
Measured: 24 months
Graft failure rate
Graft failure rate
Measured: 28 days after allo-SCT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2026
- Study start5 May 2026 (estimated)
- Primary completion5 May 2029 (estimated)
- Study completion5 May 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for T Cell Acute Lymphoblastic Leukemia/Lymphoblastic LymphomaStudies of the same condition, open and under way.
- More trials run by Shanghai General Hospital, Shanghai Jiao Tong University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 84 participants (estimated)
- Target duration
- 24 Months
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xianmin Song, MD, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07577531
- Sponsor's protocol ID
- SHSYXY-T-LBL-SCT-2025
- Status last verified
- May 2026
- First submitted
- 4 May 2026
- Last updated
- 13 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Autologous Versus Allogeneic Hematopoietic Stem Cell Transplantation for T-Lymphoblastic Leukemia/Lymphoma in First Complete Remission
- ClinicalTrials.gov ID
- NCT07577531
- Acronym / sponsor ID
- SHSYXY-T-LBL-SCT-2025
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Shanghai General Hospital, Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- 5 May 2026 (estimated)
- Primary completion
- 5 May 2029 (estimated)
- Study completion
- 5 May 2029 (estimated)
- First posted
- 11 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 24 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Autologous stem cell transplantation group | – | Procedure: different stem cell transplantation typeT-ALL/LBL patients undergoing auto-SCT in CR1 |
| Allogeneic stem cell transplantation group | – | Procedure: different stem cell transplantation typeT-ALL/LBL patients undergoing allo-SCT in CR1 |
Who may qualify
- Ages
- 14 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- T-ALL/LBL patients in first complete remission
Key inclusion criteria (10 listed)
- 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:
Key exclusion criteria (9 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| different stem cell transplantation typecohort study | Procedure or surgery | Allogeneic stem cell transplantation group, Autologous stem cell transplantation group |
Primary outcome
Relapse free survival
Time frame: 24 months
Relapse free survival
11 secondary outcomes
RFS
Time frame: 12 months
CIR
Time frame: 12 months
CIR
Time frame: 24 MONTHS
OS
Time frame: 12 months
OS
Time frame: 24 months
NRM
Time frame: 12 months
NRM
Time frame: 24 months
CI of aGVHD
Time frame: 180 days
CI of cGVHD
Time frame: 12 months
CI of cGVHD
Time frame: 24 months
Graft failure rate
Time frame: 28 days after allo-SCT
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
An observational study of T Cell Acute Lymphoblastic Leukemia/Lymphoblastic Lymphoma, run by Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 13 May 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xianmin Song (021-36123559, shongxm@sjtu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relapse free survival (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2026.