Classical Hodgkin LymphomaPhase 2NCT06848569
Sintilimab Plus AVD in Pediatric Low/Moderate Risk Hodgkin Lymphoma: A Phase II Study
A Phase 2 study testing Sintilimab in combination with AVD chemotherapy in people with Classical Hodgkin Lymphoma, run by Sun Yat-sen University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 year to 18 years
- Conditions the study is for
- Classical Hodgkin Lymphoma
- What is being tested?
- Sintilimab in combination with AVD chemotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 73 participants
- Where
- 1 siteChina
- Study dates
- 23 Oct 2024to 23 Oct 2031
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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 diameter on an upright chest X-ray or any lymph node with a maximum transverse diameter > 6cm outside the mediastinum). Intermediate-risk group: Must be a newly diagnosed patient with pathologically confirmed classical Hodgkin lymphoma, Ann Arbor stage IB, IAE, IIAE, IIIA with or without bulky disease, or IA or IIA with bulky disease, or IIB without bulky disease (B symptoms defined as: weight loss > 10%; recurrent unexplained fever with temperature > 38°C; night sweats).
- 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 lifestyle, and agreeing to maintain abstinence or use contraception as required by the protocol unless proven to be azoospermic.
- 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 donate eggs (ova, oocytes) to others or freeze/store for their own reproduction during this period.
- General condition: Lansky score ≥ 50 (age < 16 years), Karnofsky score ≥ 50 (age ≥ 16 years).
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- 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 ≥ 50×10^9/L if bone marrow involvement),Bilirubin ≤ 1.5 times the upper limit of normal (ULN) Creatinine ≤ 1.5 times ULN (calculated according to the standard Cockcroft-Gault formula).ALT/AST ≤ 3 times ULN (can be relaxed to 5 times ULN if liver metastasis is present)
- Able to comply with outpatient treatment, laboratory monitoring, and necessary clinical visits during participation in the study.
- Parents/legal guardians of pediatric or adolescent subjects have the ability to understand, consent, and sign the informed consent form (ICF) and applicable child assent form before any protocol-related procedures are initiated; subjects are able to express consent in the presence of parents/legal guardians (if applicable).
Who cannot join
- 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.
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- 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 not in the subject's best interest to participate in the study.
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong
Yizhuo Zhang, +86 020-87342460, zhangyzh@sysucc.org.cn
Junting Huang, +86 020-87342460, huangjt@sysucc.org.cn
About this study
Official title: Prospective, Single-Arm, Multicenter, Phase II Study of Sintilimab in Combination With AVD for Pediatric and Adolescent Low/Moderate Risk Classical Hodgkin Lymphoma
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
- Being tested
- Sintilimab in combination with AVD chemotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sintilimab in combination with AVD chemotherapyDrug
Sintilimab in combination with AVD chemotherapy treating classical Hodgkin lymphoma
| Study group | Role | What they receive |
|---|---|---|
| Sintilimab+AVD | Experimental | Not described Receives: Drug: Sintilimab in combination with AVD chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
4-year event-free survival
The 4-year event-free survival (EFS) rate of pediatric and adolescent patients with low-to-intermediate risk classical Hodgkin lymphoma (cHL) treated with sintilimab in combination with the AVD regimen. EFS is defined as the time from study entry to the occurrence of disease progression, relapse, second primary malignancy, or death.
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2025
- Study start23 Oct 2024
- Primary completion23 Oct 2027 (estimated)
- Study completion23 Oct 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Classical Hodgkin LymphomaStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 73 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yizhuo Zhang, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06848569
- Sponsor's protocol ID
- B2024-502-01
- Status last verified
- Feb 2025
- First submitted
- 7 Feb 2025
- Last updated
- 27 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Single-Arm, Multicenter, Phase II Study of Sintilimab in Combination With AVD for Pediatric and Adolescent Low/Moderate Risk Classical Hodgkin Lymphoma
- ClinicalTrials.gov ID
- NCT06848569
- Acronym / sponsor ID
- B2024-502-01
- Conditions
- Classical Hodgkin Lymphoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 73 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 23 Oct 2024 (actual)
- Primary completion
- 23 Oct 2027 (estimated)
- Study completion
- 23 Oct 2031 (estimated)
- First posted
- 27 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sintilimab+AVD | Experimental | Drug: Sintilimab in combination with AVD chemotherapy |
Who may qualify
- Ages
- 1 year to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (9 listed)
- 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 diameter on an upright chest X-ray or any lymph node with a maximum transverse diameter > 6cm outside the mediastinum). Intermediate-risk group: Must be a newly diagnosed patient with pathologically confirmed classical Hodgkin lymphoma, Ann Arbor stage IB, IAE, IIAE, IIIA with or without bulky disease, or IA or IIA with bulky disease, or IIB without bulky disease (B symptoms defined as: weight loss > 10%; recurrent unexplained fever with temperature > 38°C; night sweats).
- 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 lifestyle, and agreeing to maintain abstinence or use contraception as required by the protocol unless proven to be azoospermic.
- 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 donate eggs (ova, oocytes) to others or freeze/store for their own reproduction during this period.
Key exclusion criteria (20 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sintilimab in combination with AVD chemotherapySintilimab in combination with AVD chemotherapy treating classical Hodgkin lymphoma | Drug | Sintilimab+AVD |
Primary outcome
4-year event-free survival
Time frame: 4 years
The 4-year event-free survival (EFS) rate of pediatric and adolescent patients with low-to-intermediate risk classical Hodgkin lymphoma (cHL) treated with sintilimab in combination with the AVD regimen. EFS is defined as the time from study entry to the occurrence of disease progression, relapse, second primary malignancy, or death.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Sintilimab in combination with AVD chemotherapy in people with Classical Hodgkin Lymphoma, run by Sun Yat-sen University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yizhuo Zhang (+86 020-87342460, zhangyzh@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
4-year event-free survival (time frame: 4 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2025.