NCT07905066|RecruitingDMC
Hemophagocytic Lymphohistiocytosis After Allogeneic Stem Cell Transplantation
HSCT-HLH
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HSCT-HLH
Sponsor study identifier
observational
10,000
1 country
1
Study Start
October 19, 2026
Actual (reported)Primary Completion
January 31, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
December 31, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Hemophagocytic lymphohistiocytosis (HLH) is a severe inflammatory complication that can occur after allogeneic hematopoietic stem cell transplantation. Its signs can overlap with those of infection and other transplant complications, making early recognition difficult. This study will examine whether changes in routine blood tests and clinical information can help identify patients who may develop HLH during the following seven days. The study will combine a review of existing medical records with prospective follow-up at participating hospitals in China. Approximately 20,000 adults undergoing their first allogeneic transplantation will be included, with approximately 400 post-transplant HLH cases expected. Historical records will be used to develop the prediction model. Data from independent centers and prospectively enrolled patients will be used to validate the model. Participants will be followed for one year after transplantation. Those who develop HLH during that year will also be followed for 90 days after HLH onset. The study will describe HLH occurrence, associated factors, treatments, and survival. All tests and treatments will remain part of routine care. No additional research samples or laboratory tests will be required, and model predictions will not be used to guide treatment.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 31, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 19, 2026
Actual (reported)October 23, 2026
Actual (reported)October 29, 2026
Actual (reported)January 31, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
December 31, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Cumulative Incidence of First De Novo HLH Within 365 Days After Transplantation
Cumulative incidence of the first adjudicated de novo HLH episode after first allogeneic hematopoietic stem cell transplantation. HLH requires at least five of the eight HLH-2004 criteria within the same clinical episode and confirmation by the adjudication group. The onset date is the first date the study definition is met. Death and second allogeneic transplantation before HLH are competing events.
From transplantation through day 365.
Discrimination of the 7-Day HLH Risk Prediction Model
Time-dependent area under the receiver operating characteristic curve for predicting first HLH onset within the next seven days, evaluated separately in independent-center and prospective validation cohorts. Values range from 0 to 1, with higher values indicating better discrimination. Estimates account for the sampling design and follow-up.
At evaluable assessments on days 1 to 358 after transplantation, with HLH occurrence evaluated over the subsequent 7 days, through day 365.
Calibration of Predicted 7-Day HLH Risk
Agreement between predicted seven-day probabilities and observed seven-day HLH occurrence, evaluated using calibration curves in independent-center and prospective validation cohorts. Observed occurrence estimates account for the sampling design, follow-up, and competing events.
Cumulative Incidence of HLH Within 100 Days After Transplantation
From transplantation through day 100.
All-Cause Mortality Within 28 Days After HLH Onset
From HLH onset through day 28 after onset.
All-Cause Mortality Within 60 Days After HLH Onset
From HLH onset through day 60 after onset.
All-Cause Mortality Within 90 Days After HLH Onset
From HLH onset through day 90 after onset.
Overall Survival at One Year After Transplantation
From transplantation through day 365.
Patients whose first visit to our institution and the termination of follow-up both occurred before the opening of this study will contribute to the retrospective cohort.
Patients whose first visit to our institution occur after the opening of this study will contribute to the prospective cohort.
Patients whose first visit to our institution occurred before the opening of this study and whose follow-up will terminate after the opening of this study will contribute to the ambispective cohort.
Adults aged 18 years or older undergoing their first allogeneic hematopoietic stem cell transplantation at participating centers in China. The source population includes recipients who develop post-transplant HLH and those who do not. The retrospective component includes eligible transplantations from January 1, 2014, to the day before prospective study activation at each center. The prospective component consecutively enrolls eligible transplant recipients after site activation through December 31, 2029. A center- and transplant-year-stratified 15% random subcohort and all HLH cases are selected for detailed retrospective analysis.
Peking University People's Hospital
Beijing, Beijing Municipality, 100044, China
La Rosee P, Horne A, Hines M, von Bahr Greenwood T, Machowicz R, Berliner N, Birndt S, Gil-Herrera J, Girschikofsky M, Jordan MB, Kumar A, van Laar JAM, Lachmann G, Nichols KE, Ramanan AV, Wang Y, Wang Z, Janka G, Henter JI. Recommendations for the management of hemophagocytic lymphohistiocytosis in adults. Blood. 2019 Jun 6;133(23):2465-2477. doi: 10.1182/blood.2018894618. Epub 2019 Apr 16.
Henter JI, Horne A, Arico M, Egeler RM, Filipovich AH, Imashuku S, Ladisch S, McClain K, Webb D, Winiarski J, Janka G. HLH-2004: Diagnostic and therapeutic guidelines for hemophagocytic lymphohistiocytosis. Pediatr Blood Cancer. 2007 Feb;48(2):124-31. doi: 10.1002/pbc.21039.
Xiao-Hui Zhang, MD
Peking University Institute of Hematology, Peking University People's Hospital
First Submitted
October 23, 2026
First Posted
October 29, 2026
Study Start
October 19, 2026
Actual (reported)Primary Completion
January 31, 2028
EstimatedAt evaluable assessments on days 1 to 358 after transplantation, with HLH occurrence evaluated over the subsequent 7 days, through day 365.
Positive Predictive Value of 7-Day HLH Alerts
Percentage of evaluable model-positive assessments followed by adjudicated first HLH onset within the next seven days. A positive assessment is defined using the prediction threshold fixed before validation. Estimates are adjusted for the sampling design and follow-up where applicable.
At evaluable assessments on days 1 to 358 after transplantation, with HLH occurrence evaluated over the subsequent 7 days, through day 365.
Case Detection Rate for Incident HLH
Percentage of adjudicated incident HLH cases with at least one model-positive assessment during the seven days before onset, among cases with an eligible pre-onset model assessment. The prediction threshold is fixed before validation. Estimates are adjusted for the sampling design and follow-up where applicable.
At evaluable assessments on days 1 to 358 after transplantation, with HLH occurrence evaluated over the subsequent 7 days, through day 365.
Contact the study team to confirm eligibility.
Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
December 31, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
October 29, 2026
Record last verified: 2026-10
There is no current plan to share individual participant data with external researchers. The study involves multicenter clinical records, and access to patient-level data is subject to applicable ethical approvals, institutional policies, and data-use agreements.
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Source: ClinicalTrials.gov.
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