Stem cell showdown: which transplant best keeps T-Cell cancer at bay?
NCT ID NCT07577531
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looks at two stem cell transplant methods—using a patient's own cells or a donor's cells—as a follow-up treatment for people with T-cell acute lymphoblastic leukemia or lymphoma who are in their first complete remission. The goal is to see which approach better prevents the cancer from coming back and improves survival. About 84 participants aged 14-55 will be observed over time.
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Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 84 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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May 2026
An estimate. Start dates often move.
- Expected to finish
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May 2029
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
T-ALL/LBL patients in first complete remission
- Ages
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14 to 55 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
* 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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- New maintenance therapy shows promise in preventing T-Cell cancer relapse after transplant
- Engineered immune cells take on tough childhood cancers
- Engineered immune cells take on tough T-Cell cancers in new trial
- Engineered immune cells take aim at stubborn leukemia after transplant
- Engineered immune cells take on tough blood cancers in early trial