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New treatment option for Classical Hodgkin Lymphoma
Official title Sintilimab Plus AVD in Pediatric Low/Moderate Risk Hodgkin Lymphoma: A Phase II Study
ClinicalTrials.gov ID: NCT06848569
What this study is testing
What is Sintilimab in combination with AVD chemotherapy?
Sintilimab in combination with AVD chemotherapy is an investigational medicine, being studied as a potential treatment for classical hodgkin lymphoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 1 to 18
You may be able to join if
- Age between 1 and 18 years, regardless of gender.
- Low-risk group: Must be a newly diagnosed patient with pathologically confirmed classical Hodgkin lymphoma, Ann Arbor stage IA or IIA, without bulky...
- Presence of measurable lesions.
- For male participants with reproductive potential, they must agree to the following during the intervention period to be eligible: not donating...
- Female participants who are not pregnant or breastfeeding, non-reproductive potential women, or those who agree to use approved contraception for at...
You likely can't join if
- History of solid organ transplantation at any time or allogeneic hematopoietic stem cell transplantation within the past 5 years.
- Female participants with reproductive potential who test positive for pregnancy on a urine pregnancy test within 24 hours before the first dose.
- Baseline left ventricular ejection fraction \< 50% or left ventricular short-axis shortening fraction \< 27%.
- Previous treatment with anti-programmed death (PD-1), anti-programmed death ligand 1 (PD-L1), or anti-PD-L2 drugs, or drugs targeting another...
- Received any systemic anti-cancer treatment, including investigational drugs for the current diagnosis, before enrollment.
- Received live or attenuated vaccines within 30 days before the first research intervention. Inactivated vaccines are allowed.
See the full eligibility criteria
- Age between 1 and 18 years, regardless of gender.
- Low-risk group: Must be a newly diagnosed patient with pathologically confirmed classical Hodgkin lymphoma, Ann Arbor stage IA or IIA, without bulky disease (defined as a mediastinal mass diameter \> 1/3 of the chest...
- Presence of measurable lesions.
- For male participants with reproductive potential, they must agree to the following during the intervention period to be eligible: not donating sperm, practicing abstinence according to their preferred and usual...
- Female participants who are not pregnant or breastfeeding, non-reproductive potential women, or those who agree to use approved contraception for at least 120 days after the last research intervention, and agree not to...
- General condition: Lansky score ≥ 50 (age \< 16 years), Karnofsky score ≥ 50 (age ≥ 16 years).
- Laboratory tests during the screening period should meet the following conditions:Absolute neutrophil count (ANC) ≥ 1.5×10\^9/L (ANC ≥ 1.0×10\^9/L if bone marrow involvement),Platelet count (PLT) ≥ 75×10\^9/L (PLT ≥...
- Able to comply with outpatient treatment, laboratory monitoring, and necessary clinical visits during participation in the study.
- Parents/legal guardians of pediatric or adolescent people have the ability to understand, consent, and sign the informed consent form (ICF) and applicable child assent form before any protocol-related procedures are...
- History of solid organ transplantation at any time or allogeneic hematopoietic stem cell transplantation within the past 5 years.
- Female participants with reproductive potential who test positive for pregnancy on a urine pregnancy test within 24 hours before the first dose.
- Baseline left ventricular ejection fraction \< 50% or left ventricular short-axis shortening fraction \< 27%.
- Previous treatment with anti-programmed death (PD-1), anti-programmed death ligand 1 (PD-L1), or anti-PD-L2 drugs, or drugs targeting another co-inhibitory T cell receptor.
- Received any systemic anti-cancer treatment, including investigational drugs for the current diagnosis, before enrollment.
- Received live or attenuated vaccines within 30 days before the first research intervention. Inactivated vaccines are allowed.
- Received investigational drugs or used investigational devices within 4 weeks before the research intervention.
- Diagnosed with lymphocyte-predominant Hodgkin lymphoma.
- Diagnosed with immune deficiency or receiving chronic systemic corticosteroid therapy or any other form of immunosuppressive treatment within 7 days before the first administration of sintilimab.
- Known progression of other malignancies or requiring active treatment within the past 3 years.
- Presence of detectable central nervous system metastasis and/or carcinomatous meningitis on radiology at the time of diagnosis.
- Severe hypersensitivity (≥ grade 3) to any research treatment, including excipients.
- Active autoimmune disease requiring systemic treatment within the past 2 years.
- History of (non-infectious) pneumonia/interstitial pneumonitis requiring corticosteroid treatment or currently suffering from pneumonia/interstitial lung disease with active infection requiring systemic treatment.
- Known history of human immunodeficiency virus (HIV) infection.
- Known history of hepatitis B or active hepatitis C virus infection.
- Presence of any disease, treatment, or laboratory abnormality results that may confound study results, interfere with the subject's participation throughout the study, or, in the opinion of the treating investigator, is...
- Known mental illness or substance abuse disorder that would interfere with cooperation with the study requirements.
- Patient has not fully recovered from major surgery or has persistent postoperative complications.
- Other conditions that the investigator considers should be excluded.
The study team makes the final eligibility decision.
Where it's taking place
- Guangzhou, Guangdong, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 1 year to 18 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Guangzhou, Guangdong, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.