NCT04999878

A Prospective Clinical Study of Ruxolitinib and Etoposide Combined With DDGP Regimen (RUE-DDGP) in Induction Therapy of T/NK Cell Lymphoma-associated Hemophagocytic Syndrome.

A Prospective Clinical Study of Ruxolitinib Phosphate Tablets and Etoposide Combined With DDGP Regimen (RUE-DDGP) in Induction Therapy of T/NK Cell Lymphoma-associated Hemophagocytic Syndrome.

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Zhengzhou University · Academic / Other
• Sex: All
• Age: 14 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

To observe the efficacy and safety of Ruxolitinib and Etoposide combined with DDGP regimen ( cis-Platinum, Dexamethasone, Gemcitabine and Pegaspargase) in the first-line induction therapy of T cell lymphoma and NK/T cell lymphoma-associated hemophagocytic syndrome.

Detailed description

This is an open, one-arm, prospective clinical collaborative study. This study is aimed to observe the efficacy and safety of the new combined therapy of Ruxolitinib and Etoposide combined with DDGP regimen ( cis-Platinum, Dexamethasone, Gemcitabine and Pegaspargase) in the first-line induction therapy patients with primary central nervous system lymphoma. A total of 30 patients plan to participate in the study. The primary endpoint is objective remission rate (ORR) of hemophagocytic syndrome, and the secondary endpoints include progression-free survival (PFS) , objective remission rate (ORR) of lymphoma, overall survival (OS), and adverse events(ADR).

Conditions

• Hemophagocytic Syndrome
• T/NK-Cell Lymphoma

Interventions

Type	Name	Description
DRUG	Ruxolitinib, Etoposide, Dexamethasone, Gemcitabine, Pegaspargase, cis-platinum	All enrolled patients will receive a regimen containing Ruxilitinib, Etoposide, Dexamethasone, Gemcitabine, Pasparase and Platinum for 28 days. The specific medication is as follows: Ruxilitinib 10 mg, bid, d1-28, P.O. Etoposide 100mg per week, two weeks, ivgtt Dexamethasone, 15mg/(m²·d)，d1-12，10 mg/ (m²·d) ，d13-14，5 mg/ (m²·d) ，d15-21，2.5mg/(m²·d)，d22-28，ivgtt or P.O. Gemcitabine, 0.5 g/m², d8, ivgtt Pegaspargase, 2500IU/m², d9, im Platinum, 20mg/m² d10 d11, ivgtt After the treatment, patients will be given disease specific chemotherapy regimen to treat lymphoma according to patient's different lymphoma subtype.

Timeline

• Start date: 2021-05-30
• Primary completion: 2023-06-30
• Completion: 2024-06-30
• First posted: 2021-08-11
• Last updated: 2021-08-11

Locations

1 site across 1 country: China