Comparing ATLG and ATG for immune recovery after allogeneic stem cell transplant
An Exploratory, Non-Randomized, Controlled Study of the Effect of Rabbit Anti-Human T-Lymphocyte Immunoglobulin (ATLG) Versus Anti-Thymocyte Immunoglobulin (ATG) on Immune Reconstitution After Allogeneic Hematopoietic Stem Cell Transplantation for Malignant Hematologic Diseases
This study will try using ATLG instead of ATG in adults receiving allogeneic stem cell transplants for blood cancers to see if immune recovery is faster and rates of viral infection or GVHD are lower.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 24 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Peking University First Hospital Academic / other |
| Locations | 1 site (Beijing) |
| Trial ID | NCT06895538 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults (≥18 years) with histologically or cytologically confirmed malignant hematologic disease who are undergoing their first allogeneic HSCT, have ECOG 0–2, and meet specified organ-function criteria are the intended participants.
Not a fit: People with recent prior exposure to ATG/ALG/ATLG, significant uncontrolled organ dysfunction, active severe infection, or who are not candidates for allo-HSCT are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If ATLG leads to faster or more complete immune recovery, patients could face fewer life-threatening viral infections and potentially less severe GVHD after transplant.
How similar studies have performed: Prior clinical reports and transplant series suggest ATLG can reduce GVHD and may lower CMV reactivation compared with some ATG approaches, but evidence is not yet definitive in prospective comparative settings.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Beijing
- Peking University First Hospital — Beijing, China (Recruiting)
Study contacts
- Study coordinator: Jialin Zhu, MD
- Email: julie920219@163.com
- Phone: +86-13671375500
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.