Actively Recruiting
Sintilimab Plus AVD in Pediatric Low/Moderate Risk Hodgkin Lymphoma: A Phase II Study
Led by Sun Yat-sen University · Updated on 2025-02-27
73
Participants Needed
1
Research Sites
365 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Sintilimab Plus AVD in Pediatric Low/Moderate Risk Hodgkin Lymphoma: A Phase II Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 1 and 18 years, any gender
- Newly diagnosed classical Hodgkin lymphoma with low or intermediate risk per Ann Arbor stages IA, IB, IAE, IIA, IIAE, IIIA with or without bulky disease
- Presence of measurable lesions
- Male patients with reproductive potential agree to avoid sperm donation and practice abstinence or contraception during treatment
- Female patients not pregnant or breastfeeding, or agree to use approved contraception for at least 120 days after treatment and avoid egg donation or freezing
- Lansky score 64 50 for age under 16 years, Karnofsky score 64 50 for age 16 years or older
- Laboratory values meeting specified limits for neutrophils, platelets, bilirubin, creatinine, and liver enzymes
- Ability to comply with outpatient treatment, lab monitoring, and clinical visits
- Parents or guardians able to provide informed consent and patients able to provide assent as appropriate
You will not qualify if you...
- History of solid organ transplant or allogeneic stem cell transplant within past 5 years
- Female patients pregnant within 24 hours before first dose
- Baseline heart function below specified thresholds
- Previous treatment with PD-1, PD-L1, PD-L2 inhibitors or similar drugs
- Prior systemic anti-cancer treatment for current diagnosis
- Live or attenuated vaccines within 30 days before treatment
- Investigational drugs or devices within 4 weeks before treatment
- Diagnosis of lymphocyte-predominant Hodgkin lymphoma
- Immune deficiency or recent immunosuppressive treatment
- Other malignancies requiring active treatment within past 3 years
- Central nervous system metastasis or carcinomatous meningitis
- Severe hypersensitivity to study treatments
- Active autoimmune disease needing systemic treatment within past 2 years
- History or current serious lung infections or inflammation
- Known HIV, hepatitis B, or active hepatitis C infection
- Conditions interfering with participation or study results
- Mental illness or substance abuse affecting cooperation
- Not recovered from major surgery or with postoperative complications
- Other investigator-determined exclusion conditions
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
Actively Recruiting
Research Team
Y
Yizhuo Zhang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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