Skip to content

A prospective, single-center, single-arm, pilot study evaluating the efficacy and safety of jaktinib combined with dexamethasone in adult patients with newly diagnosed hemophagocytic lymphohistiocytosis

A prospective, single-center, single-arm, pilot study evaluating the efficacy and safety of jaktinib combined with dexamethasone in adult patients with newly diagnosed hemophagocytic lymphohistiocytosis

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500110740
Enrollment
Unknown
Registered
2025-10-20
Start date
2025-10-20
Completion date
Unknown
Last updated
2025-10-27

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

Conditions

Hemophagocytic lymphohistiocytosis

Interventions

Experimental Group:Jaktinib plus dexamethasone

Sponsors

The FIrst Affiliated Hospital, College of Medicine, Zhejiang University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Meet the diagnostic criteria of HLH-2004; 2. Age >=18 years old; 3. Has not received any HLH treatment regimens containing etoposide; 4. Understand this research and sign the informed consent form; 5. Men, women of childbearing age (postmenopausal women who have been menopausal for at least 12 months or more are considered infertile) and their partners voluntarily take contraceptive measures deemed effective by the researchers during the treatment period and for at least three months after the last use of the study drug; 6. Expected survival period > 2 weeks;

Exclusion criteria

Exclusion criteria: 1.Central nervous system involvement; 2.Known HIV infection; 3.Individuals with severe renal dysfunction (glomerular filtration rate 20); 5.Individuals who have suffered from malignant tumors within the past five years (excluding cured skin basal cell carcinoma and cervical carcinoma in situ); 6.Pregnant or lactating women; 7.Failure to understand or comply with the research protocol; 8.Combining other serious diseases, researchers believe may affect patient safety or compliance. 9.Previous use of or current treatment with JAK inhibitors for HLH; 10.Suspected allergic reaction to study drug; 11.Patients who are taking other investigational drugs or participating in other clinical studies;

Design outcomes

Primary

MeasureTime frame
Safety;Overall survival rate within 2 month;

Secondary

MeasureTime frame
Progression-free survival;Response rate;Time to Response;HLH-related indicator trends;

Countries

China

Contacts

Public ContactJin Jie

The First Affiliated Hospital of Zhejiang University School of Medicine

jiej0503@163.com+86 571 8723 5560

Outcome results

None listed

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