NCT06895538 Comparison of ATLG and ATG for Immune Reconstitution After Allo-HSCT for Hematologic Malignancy
| NCT ID | NCT06895538 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Peking University First Hospital |
| Condition | Leukemia |
| Study Type | OBSERVATIONAL |
| Enrollment | 24 participants |
| Start Date | 2025-05-03 |
| Primary Completion | 2026-01-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 24 participants in total. It began in 2025-05-03 with a primary completion date of 2026-01-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Allogeneic hematopoietic stem cell transplantation is the only curative treatment for malignant hematologic diseases. However, immune rejection is a major limitation in its application. In the "Beijing Protocol", the use of granulocyte colony-stimulating factor (G-CSF) in combination with anti-thymocyte globulin (ATG) can achieve "everyone has a donor". The use of ATG, however, can interfere with the recovery of immune function after transplantation, increasing the risk of life-threatening complications such as viral infections or graft-versus-host disease. Rabbit anti-human T-lymphocyte immunoglobulin (ATLG) is currently approved for the prevention of organ transplant rejection, which is produced differently from ATG. Previous studies have shown that transplant preconditioning with ATLG is effective in preventing graft-versus-host disease and even reduces the incidence of cytomegalovirus, etc. after transplantation. In this study, we will prospectively apply containing ATLG in a cohort of allogeneic hematopoietic stem cell transplantation for malignant hematologic diseases and dynamically observe the state of immune reconstitution of patients after transplantation. We will also compare it with a matched cohort of conventional combined ATGs during the same period to explore the impact of ATLG on immune reconstitution after transplantation.
Eligibility Criteria
Inclusion Criteria: * 1）Age ≧18 years, gender is not limited; * 2）Histologically or cytologically confirmed diagnosis of malignant hematologic diseases; * 3\) First time undergoing allogeneic hematopoietic stem cell transplantation; * 4\) ECOG score 0-2; * 5\) Hepatic and renal function, cardiopulmonary function meet the following requirements. * Serum creatinine ≤ 1.5 ULN; ②Left ventricular ejection fraction ≥ 45%; * Blood oxygen saturation \>91%; * Total bilirubin ≤ 2 × ULN; ALT and AST ≤ 3 × ULN; for ALT and AST abnormalities due to disease (e.g., liver infiltrates or bile duct obstruction), in the judgment of the investigator, the values may be adjusted to ≤ 5 × ULN; * 6\) Expected survival is longer than 12 weeks; * 7\) The subjects will voluntarily and strictly comply with the requirements of the study protocol and will sign a written informed consent form. Exclusion Criteria: * 1\) Prior treatment with ATG, ALG, or ATLG drugs within the past six months; * 2\) Allergic to any component of ATLG or ATG; * 3\) Bacterial, viral, parasitic, or mycobacterial infections not adequately controlled by treatment, i.e., inability to undergo hematopoietic stem cell transplantation due to severe infection. 4\) Women who are pregnant or breastfeeding, or participants of childbearing potential who are unwilling or unable to use effective methods of contraception; 5) Participants enrolled in another clinical trial (of any investigational drug or device) within 30 days prior to the subject's baseline visit. (Subjects enrolled in observational studies are eligible to participate). 6\) Any other circumstance that, in the judgment of the investigator, may interfere with the conduct of the clinical trial and the determination of the results of the trial.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06895538 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Leukemia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06895538 currently recruiting?
Yes, NCT06895538 is actively recruiting participants. Contact the research team at julie920219@163.com for enrollment information.
Where is the NCT06895538 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT06895538 clinical trial?
NCT06895538 is sponsored by Peking University First Hospital. The trial plans to enroll 24 participants.
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