HLH after stem cell transplant: can routine blood tests flag risk in the next week?
Official title: Hemophagocytic Lymphohistiocytosis After Hematopoietic Stem Cell Transplantation: A Multicenter Ambispective Longitudinal Cohort Study
Run by Peking University People's Hospital · NCT07905066 · Data updated 2026-11-12
This study tests whether changes in common blood tests and clinical data can predict HLH within seven days after a first allogeneic stem cell transplant.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 10000 (estimated) |
| Sponsor | Peking University People's Hospital Academic / other |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Status | Recruiting |
| Started | October 19, 2026 |
| Main results expected | January 31, 2028 |
| Study ends | December 31, 2029 |
| Registry record updated | October 29, 2026 |
| Trial ID | NCT07905066 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults 18 years or older undergoing their first allogeneic hematopoietic stem cell transplant at participating centers.
✕Probably not a fit
Patients who do not develop HLH or whose HLH signals are not captured by routine data may not benefit from the model.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This multicenter, ambispective observational cohort will develop and validate a dynamic model to predict post-transplant HLH occurring within seven days. It combines retrospective data (from 2014 onward) with prospective follow-up at participating Chinese hospitals and uses a stratified case-cohort design to study de novo HLH after allo-HSCT. Eligible adults (≥18) undergoing their first allo-HSCT are followed for one year, with HLH diagnosed after transplantation excluded if present before transplant. The study aims to use routine laboratory results and clinical information to identify early signals of HLH, with validation across independent centers and prospectively enrolled patients.
Why it matters
Potential benefit: If successful, the model could help clinicians recognize HLH earlier and start timely interventions post-transplant.
How similar studies have gone: Prior work in HLH prediction exists in smaller cohorts; this study aims to validate a dynamic, seven-day horizon across multiple centers, which is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age 18 years or older at first allogeneic hematopoietic stem cell transplantation. First allogeneic hematopoietic stem cell transplantation performed at a participating center within the study period. Verifiable transplantation date and basic clinical information. Written informed consent from the participant or legally authorized representative for prospective participation. Retrospective records are used under the applicable ethics-approved consent or waiver procedures. Exclusion Criteria: * Autologous transplantation or transplantation other than hematopoietic stem cell transplantation. HLH diagnosed before transplantation, or transplantation performed primarily for HLH. Previous allogeneic hematopoietic stem cell transplantation. Patient identity, transplantation date, or key outcome information cannot be verified. Explicit refusal to participate or to permit the use of clinical information for this study.
Where it's running
-
Peking University People's Hospital
Beijing, Beijing Municipality, China Recruiting
Study contacts
- Principal investigator: Xiao-Hui Zhang, MD — Peking University Institute of Hematology, Peking University People's Hospital
- Study coordinator: Jin Wu, MD
- Email: wujin1996@126.com
- Phone: 086-01088326002
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.