Dose-modified Emapalumab and Ruxolitinib (E-Ru) Regimens for Hemophagocytic Lymphohistiocytosis

NCT06951971 | Not Yet Recruiting Phase 2

• 1 other identifier: E-Ru
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This study is trying to evaluate the efficacy and safety of dose-modified Emapalumab and Ruxolitinib (E-Ru) regimens for the treatment of active hemophagocytic lymphohistiocytosis.

Conditions

Hemophagocytic Lymphohistiocytosis (HLH)

Outcome Measures

Primary Outcomes (1)

• 60-days OS

  overall survival (OS) rate at 60 days (2-month OS)

  60 days

Secondary Outcomes (5)

• Response rate

  7, 14, 28, and 56 days

• Security

  7, 14, 28, and 56 days

• EFS

  6 months

• Overall survival

  6 months

• Trend of related indicators

  7, 14, 28, and 56 days

Study Arms (1)

E-Ru for HLH

EXPERIMENTAL

dose-modified Emapalumab+Ruxolitinib for the treatment of HLH patients.

Drug: dose-modified E-Ru; Other: Salvage treatment and follow-up

Interventions

dose-modified E-Ru DRUG

Emapalumab (1-2 mg/kg intravenously once weekly for 8 weeks) + Ruxolitinib (15-30 mg orally twice daily for 8 weeks)

E-Ru for HLH

Salvage treatment and follow-up OTHER

1\) for patients who did not respond to the E-Ru regimen after 7 days or who relapsed at any point during treatment, a rescue regimen such as HLH-94 or doxorubicin-etoposide-methylprednisolone (DEP) was administered; 2) for patients diagnosed with lymphoma after enrollment, chemotherapy was initiated; 3) for patients who completed 8 weeks of treatment without recurrence and had no detected HLH-related gene mutations, follow-up was initiated; and 4) for patients who met the criteria for allo-HSCT, allo-HSCT was performed.

E-Ru for HLH

Eligibility Criteria

• Age: 1 Year - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Fulfillment of at least five of the eight HLH-2004 criteria for HLH;
• Age 1-70 years old;
• No prior chemotherapy for HLH;
• Confirmed not pregnant and willing to use effective contraceptive measures during the study period, with the last dose of medication administered at least 12 months prior;
• Signed informed consent prior to study participation.

You may not qualify if:

• According to the New York Heart Association (NYHA) score, patients with heart disease of grade II or above (including grade II);
• HIV-infected patients;
• Patients with severe renal dysfunction (glomerular filtration rate \<15 mL/min);
• Patients with severe liver cirrhosis (MELD score\>20);
• Uncontrollable infections (including lung infections, intestinal infections, etc.);
• Have serious mental illness;
• Have a history of active tumor;
• Participate in other clinical investigators at the same time;
• People with central nervous system involvement;

Sponsors & Collaborators

• The First Affiliated Hospital of Soochow University: lead

Study Sites (1)

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, 215006, China

Location

MeSH Terms

Conditions

Lymphohistiocytosis, Hemophagocytic

Interventions

Salvage Therapy

Condition Hierarchy (Ancestors)

Histiocytosis, Non-Langerhans-Cell; Histiocytosis; Lymphatic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Xuefeng He, Dr.

  The First Affiliated Hospital of Soochow University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yue Song, Dr

CONTACT

+86 18810253070; xueqifeng1992@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: The First Affiliated Hospital of Soochow University

Study Record Dates

• First Submitted: April 23, 2025
• First Posted: April 30, 2025
• Study Start: June 1, 2025
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2028
• Last Updated: April 30, 2025

Record last verified: 2025-04

Locations

CN (1)