RecruitingPhase 2NCT06848569

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


Sponsor

Sun Yat-sen University

Enrollment

73 participants

Start Date

Oct 23, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 1 YearMax Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether adding sintilimab (an immunotherapy drug) to standard chemotherapy (AVD regimen) improves treatment outcomes for children and teenagers with low- to moderate-risk classical Hodgkin lymphoma — a cancer of the lymph nodes. **You may be eligible if...** - You are between 1 and 18 years old - You have a newly diagnosed classical Hodgkin lymphoma confirmed by biopsy - Your disease is classified as low-risk (stage IA or IIA without a large chest mass) or moderate-risk (stage I/II with a large chest mass, or stage IIIA) - You have not received any prior treatment for this cancer **You may NOT be eligible if...** - You have high-risk or advanced-stage Hodgkin lymphoma (stage IIIB or IV) - You have received prior cancer treatment - You have significant heart, liver, kidney, or immune system problems - You have an active infection or autoimmune condition Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGSintilimab in combination with AVD chemotherapy

Sintilimab in combination with AVD chemotherapy treating classical Hodgkin lymphoma


Locations(1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

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NCT06848569


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