NCT06848569

Sintilimab Plus AVD in Pediatric Low/Moderate Risk Hodgkin Lymphoma: A Phase II Study

Prospective, Single-Arm, Multicenter, Phase II Study of Sintilimab in Combination With AVD for Pediatric and Adolescent Low/Moderate Risk Classical Hodgkin Lymphoma

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 73 (estimated)
• Sponsor: Sun Yat-sen University · Academic / Other
• Sex: All
• Age: 1 Year – 18 Years
• Healthy volunteers: Not accepted

Summary

Study Purpose: To evaluate the efficacy and safety of sintilimab in combination with AVD chemotherapy for the treatment of pediatric and adolescent patients with low-to-intermediate risk classical Hodgkin lymphoma (cHL). Study Design: This is a prospective, single-arm, multicenter, phase II clinical trial. Study Population: Pediatric and adolescent patients aged 1 to 18 years, diagnosed with classical Hodgkin lymphoma, and classified as low-to-intermediate risk according to the Ann Arbor staging system. Treatment Plan: Sintilimab in combination with AVD chemotherapy, administered every two weeks for a planned 4-6 cycles.

Conditions

• Classical Hodgkin Lymphoma

Interventions

Type	Name	Description
DRUG	Sintilimab in combination with AVD chemotherapy	Sintilimab in combination with AVD chemotherapy treating classical Hodgkin lymphoma

Timeline

• Start date: 2024-10-23
• Primary completion: 2027-10-23
• Completion: 2031-10-23
• First posted: 2025-02-27
• Last updated: 2025-02-27

Locations

1 site across 1 country: China