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A prospective, single-center, randomized controlled clinical study evaluating the efficacy and safety of ruxolitinib combined with dexamethasone versus HLH-1994 in adult patients with newly diagnosed hemophagocytic lymphohistiocytosis

A prospective, single-center, randomized controlled clinical study evaluating the efficacy and safety of ruxolitinib combined with dexamethasone versus HLH-1994 in adult patients with newly diagnosed hemophagocytic lymphohistiocytosis

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400085248
Enrollment
Unknown
Registered
2024-06-04
Start date
2024-06-01
Completion date
Unknown
Last updated
2024-07-08

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

Conditions

hemophagocytic lymphohistiocytosis

Interventions

Study group:Ruxolitinib combined with dexamethasone(Ru-D regimen): The Ru-D regimen consists of ruxolitinib (15 mg twice daily for 8 weeks) and dexamethasone (initially 10 mg/m2 for 2 weeks followed b
Control froup:HLH-1994 regimen consists of Etoposide (150 mg/m2 twice every week in the first 2 weeks, and weekly in the rest weeks) and dexamethasone (initially 10 mg/m2 for 2 weeks followed by 5 mg/

Sponsors

The first affiliated hospital Zhejiang University school of medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Meet the diagnostic criteria of HLH-2004 2. Age =18 years old 3. Did not receive an HLH regimen containing etoposide 4. Understand the study and sign the informed consent 5. Men, women of childbearing age (postmenopausal women who must have been at least 12 months past menopause to be considered infertile), and their partners voluntarily used contraception deemed effective by the investigators during treatment and for at least three months after the last time they took the study drug

Exclusion criteria

Exclusion criteria: 1. Known central nervous system involvement 2. Known HIV infection 3. Patients with severe renal dysfunction (glomerular filtration rate 20) 5. Known history of active tumor 6. Pregnant or lactating women 7. Inability to understand or follow research protocols

Design outcomes

Primary

MeasureTime frame
overall survival;

Secondary

MeasureTime frame
overall survival rate;complete remission rate;partial remission rate;Improvement in measures of HLH;Progression-free survival;The time to remission;Change trend of related biological indicators;safety;

Countries

China

Contacts

Public ContactHongyan Tong

The first affiliated hospital Zhejiang University school of medicine

ruicostas610@sina.com+86 139 5812 2357

Outcome results

None listed

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