RecruitingPhase 2/3

Comparison of ATLG and ATG for Immune Reconstitution After Allo-HSCT for Hematologic Malignancy

China24 participantsStarted 2025-05-03

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 da…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1This trial is comparing two different anti-thymocyte globulin drugs — ATLG and ATG — to see which leads to fewer viral infections after a stem cell transplant; can you explain what the key differences are between these two drugs and why that comparison matters for my specific diagnosis of leukemia, MDS, or lymphoma?
2Since this is a Phase 2/3 trial, there's still some uncertainty about which of these two approaches is safer and more effective — how does that level of uncertainty compare to what's already known from standard care, and should I consider a more established treatment path first?
3Viral infections after a stem cell transplant can be serious and even life-threatening — based on what's known so far about ATLG versus ATG, are there any early signals about which one better protects against the specific viruses that are most dangerous after transplant?
4What would my monitoring schedule look like if I were to participate in this trial, and how does the added burden of tracking viral infection outcomes fit with the recovery process I'd already be going through after an allogeneic stem cell transplant?
5Am I likely to be randomly assigned to one drug or the other, and if so, is there a possibility I'd receive the option my care team thinks is less ideal for my particular situation?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Incidence of viral infections after hematopoietic stem cell transplantation

Timeframe: From enrollment to 1 year after allo-HSCT

Trial details

NCT IDNCT06895538

SponsorPeking University First Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-02-28

Contact for this trial

Jialin Zhu, MD

+86-13671375500 julie920219@163.com

View on ClinicalTrials.gov More Leukemia trials