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The efficacy and safety of the combination of selinexor, etoposide, and dexamethasone in the treatment of critically ill patients with hemophagocytic syndrome: a prospective, single arm clinical study.

The efficacy and safety of the combination of selinexor, etoposide, and dexamethasone in the treatment of critically ill patients with hemophagocytic syndrome: a prospective, single arm clinical study.

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500096507
Enrollment
Unknown
Registered
2025-01-24
Start date
2025-02-01
Completion date
Unknown
Last updated
2025-01-27

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

Conditions

critical hemophagocytic syndrome

Interventions

Interventions group:Selinexor plus etoposide and dexamethasone

Sponsors

The First Affiliated Hospital of Soochow University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
16 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1.Age 16-70 years old, gender not limited, meets the HLH-2004 diagnostic criteria; 2.HLH patients with SOFA Score 2 or more of at least one organ system excluding coagulation/hematologic system,and/or any need for organ replacement therapy due to organ failure, including positive-pressure ventilation, renal replacement therapy, vasopressors, and extracorporeal life support; 3.Expected survival period exceeds one month; 4.No history of drug allergies within the protocol; 5.Participants with pregnancy plans must agree to use contraception before enrollment in the study and after the study lasts for six months; If the subject is pregnant or suspected of being pregnant, the researcher should be notified immediately; 6.The subjects understand and sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1.Uncontrolled active infections (including bacterial, fungal, or viral infections), unless the researchers consider the infection to be related to HLH; 2.Participate in other clinical studies, or plan to start treatment in this study less than 4 weeks after the end of the previous clinical study treatment; 3.Have a history of allergies to the drugs within the protocol; 4.Female subjects are in pregnancy and lactation period; 5.Human immunodeficiency virus (HIV) infection or syphilis infection; 6.Active hepatitis that has not been controlled after active antiviral treatment; 7.Other situations that researchers consider unsuitable for participation in the study.

Design outcomes

Primary

MeasureTime frame
objective response rate;

Secondary

MeasureTime frame
safety;duration of response?Progression-freesurvival?Overall survival;

Countries

China

Contacts

Public Contactfu jianhong

The First Affiliated Hospital of Soochow University

fujianhong@suda.edu.cn+86 512 67781335

Outcome results

None listed

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