Comparing ATLG and ATG for immune recovery after allogeneic stem cell transplant

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective observational comparison of rabbit anti-human T-lymphocyte immunoglobulin (ATLG) versus conventional ATG in adults undergoing first allogeneic hematopoietic stem cell transplantation for leukemia, MDS, or lymphoma under the Beijing Protocol. Participants receive standard transplant conditioning and graft procedures with either ATLG-containing regimens or ATG, and immune reconstitution, viral reactivation (CMV/EBV), graft-versus-host disease, and clinical outcomes are followed longitudinally. The study measures kinetics of T- and B-cell recovery, incidence and timing of infections and GVHD, and transplant-related morbidity and mortality. Results will be used to compare safety and post-transplant immune function between the two preparations.

Why it matters

Who can join: the full rules

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.

Where it's running

• Peking University First Hospital
  Beijing, China Recruiting

Study contacts

• Study coordinator: Jialin Zhu, MD
• Email: julie920219@163.com
• Phone: +86-13671375500

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.