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Cytokine Guided Diangosis, Risk Stratification and Treatment in Pediatric Hemophagocytic Lymphohistiocytosis

Clinical Study on the Diagnosis and Treatment of Pediatric Hemophagocytic Lymphohistiocytosis Based on Cytokine Guided Risk Stratification: A Prospective Study

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300076631
Enrollment
Unknown
Registered
2023-10-13
Start date
2017-01-01
Completion date
Unknown
Last updated
2023-10-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hemophagocytic lymphohistiocytosis

Interventions

DXM group:Dexamethasone (DXM): week1-2: 10 mg/m2.d, week 3-4: 5 mg/m2.d, week5-6: 2.5 mg/m2.d, week7: 1.25 mg/m2.d, week8: tapering.
HLH-94 group:DXM: week1-2: 10 mg/m2.d, week 3-4: 5 mg/m2.d, week5-6: 2.5 mg/m2.d, week7: 1.25 mg/m2.d, week8: tapering. Etoposide (VP16): 150 mg/m2 in the first two weeks, twice a week, 150 mg/m2 in 3

Sponsors

the Children's Hospital of Zhejiang University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
No minimum to 18 Years

Inclusion criteria

Inclusion criteria: 1.Age from one day to 18 years old; 2.Newly diagnosed HLH, fulfilling the HLH criteria; 3.To observed the early diagnosis role of cytokines, patients who is suspected to be HLH and fulfill 3 out of 8 criteria can be pre-enrolled; 4.Signed an informed consent form before participating in the study

Exclusion criteria

Exclusion criteria: 1.Treated with steroids or etoposide within 72 hours before diagnosis. 2.Patient has prior HLH therapy. 3.History of severe allergic, anaphylactic, or other hypersensitivity reactions to chemicals. 4.Patients diagnosed with tumor-associated HLH and macropahge activation syndrome were excluded from the stratification treatmet. 5.Other problems which make the patients unable to undergo this clinical trials.

Design outcomes

Primary

MeasureTime frame
Complete response;Overall survival;Overall response rate;Event-free survival ;

Secondary

MeasureTime frame
Reactivation rate;Rate of Early Death;Sustained remission;

Countries

China

Contacts

Public ContactYongmin Tang

Children’s Hospital of Zhejiang University School of Medicine

y_m_tang@zju.edu.cn+86 571 8887 3450

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026