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A single center, prospective, single arm, phase II clinical study to evaluate the efficacy and safety of Ruxolitinib and dexamethasone in the treatment of adult primary hemophagocytic syndrome

A single center, prospective, single arm, phase II clinical study to evaluate the efficacy and safety of Ruxolitinib and dexamethasone in the treatment of adult primary hemophagocytic syndrome

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100049996
Enrollment
Unknown
Registered
2021-08-15
Start date
2021-08-16
Completion date
Unknown
Last updated
2022-05-30

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

Conditions

Adult primary hemophagocytic syndrome

Interventions

Group A:Ruxolitinib+dexamethasone

Sponsors

the First Affiliated Hospital, College of Medicine, Zhejiang University
Lead Sponsor

Eligibility

Sex/Gender
Male

Inclusion criteria

Inclusion criteria: 1. Meet the HLH-2004 diagnostic criteria; 2. Age>=18; 3. Women of childbearing age must be confirmed by a pregnancy test that they are not pregnant, and are willing to take effective contraceptive measures during the test period and within >= 12 months after the last dose; pregnant and lactating women cannot participate; Take contraceptive measures during the test period and within >=3 months after the last dose; 4. Can provide informed consent, can understand and comply with the requirements of the study.

Exclusion criteria

Exclusion criteria: 1. According to the New York Heart Association (NYHA) score, patients with heart disease of grade II or above (including grade II); 2. HIV-infected patients; 3. Patients with severe renal dysfunction (glomerular filtration rate 20); 5. Uncontrollable infections (including lung infections, intestinal infections, etc.); 6. Have serious mental illness; 7. Have a history of active tumor; 8. Participate in other clinical investigators at the same time; 9. People with central nervous system involvement; 10. Exclusion criteria related to concomitant medication.

Design outcomes

Primary

MeasureTime frame
Overall survival at 60 days;

Secondary

MeasureTime frame
Response rate (ORR, CR, PR);Overall survival at 6 months;Time required to achieve remission;Duration of remission;Trend of related indicators;Security;

Countries

China

Contacts

Public ContactYe Xiujin

The First Affiliated Hospital, College of Medicine, Zhejiang University

yxjsunny@zju.edu.cn+86 13600519298

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 12, 2026