NCT06701344

Go-CHOP in de Novo Intestinal T-cell Lymphoma Patients

A Prospective, Multicenter, Single-arm Phase II Clinical Trial to Evaluate the Safety and Efficacy of the Combination Therapy of Go-CHOP in de Novo Intestinal T-cell Lymphoma Patients

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 7 (estimated)
• Sponsor: Ruijin Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The goal of this observational study is to evaluate the safety and efficacy of Go-CHOP (Golidocitinib plus Cyclophosphamide, Hydroxydoxorubicin, Oncovin and Prednisone) in de novo intestinal T-cell lymphoma patients, The aim is to evaluate the complete response rate (CRR). Participants will receive Go-CHOP for 6 cycles every 21 days followed by either maintenance therapy or ASCT.

Conditions

• Enteropathy Associated T Cell Lymphoma

Interventions

Type	Name	Description
DRUG	Go-CHOP (Golidocitinib plus Cyclophosphamide, vincristine, doxorubicin and prednisone)	Induction Treatment: Golidocitinib:150mg QD Cyclophosphamide:750mg/m2，d1 vincristine:1.4mg/m2，d1(max 2mg) doxorubicin:50mg/m2，d1 Prednisone:60mg/m2 (max 100mg)，d1-d5 Every 21 days
DRUG	Golidocitinib	Maintenance Treatment: Complete remission patients will further divide into two groups. Unfit, frail old patients will receieve Golidocitinib 150mg QD for two years. Fit, young patients will receive ASCT.

Timeline

• Start date: 2024-12-04
• Primary completion: 2026-05-04
• Completion: 2027-12-04
• First posted: 2024-11-22
• Last updated: 2024-11-22