Hodgkin LymphomaPhase 1/2NCT07641010
PD-1 Antibody and JAK1 Inhibitor for Newly Diagnosed Pediatric Hodgikin's Lympoma
A Phase 1/2 study testing PD-1+JAK1i and PD-1 in people with Hodgkin Lymphoma, run by Shanghai Jiao Tong University School of Medicine at 1 site in China.
Trial summary
A prospective, multicenter, randomized controlled clinical study of camrelizumab in combination with ivarmacitinib as first-line treatment for pediatric classical Hodgkin lymphoma Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Hodgkin Lymphoma
- What is being tested?
- PD-1+JAK1i and PD-1
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- 1 siteChina
- Study dates
- 30 Jun 2026to 30 Sep 2030
- Phase
- Phase 1/2
- 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 6 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age 6-18 years, male or female;
- Histologically confirmed classic Hodgkin lymphoma;
- Newly diagnosed, previously untreated patients;
- Subjects must have at least one measurable lesion, defined as: a lymph node lesion with the longest diameter >1.5 cm on CT cross-sectional imaging; or an extranodal lesion with the longest diameter >1.0 cm;
- ECOG performance status (PS) 0-2;
- Life expectancy ≥3 months;
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- All screening laboratory tests must be performed as required by the protocol and within 7 days prior to enrollment. The laboratory values obtained at screening must meet the following criteria:
- Hematology (without blood transfusion, G-CSF, or medication to correct abnormalities within 14 days prior to screening):
- Hemoglobin (Hb) ≥70 g/L;
- Absolute neutrophil count (ANC) ≥0.5×10⁹/L;
- Platelet count (PLT) ≥30×10⁹/L;
- Biochemistry:
- Direct bilirubin (DBIL) <2 × upper limit of normal (ULN);
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤5 × ULN;
- Serum creatinine clearance ≥40 mL/min;
- The patient or his/her legal guardian has signed the informed consent form (ICF) and voluntarily agrees to participate in this study.
Who cannot join
- Histopathologically confirmed nodular lymphocyte-predominant Hodgkin lymphoma (NLPHL);
- Prior anti-tumor therapy for classic Hodgkin lymphoma (cHL);
- Patients with central nervous system (CNS) involvement by lymphoma;
- Inability to swallow oral medication, or any other factor affecting oral drug administration and absorption;
- Presence of any active, known, or suspected autoimmune disease (subjects who are in a stable condition and do not require systemic immunosuppressive therapy are permitted to enroll);
- Use of immunosuppressive agents, including systemic corticosteroids, within 14 days prior to study drug administration (use of ≤10 mg/day prednisone or equivalent is permitted);
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- History of other malignancies within the past 5 years;
- Severe cardiac dysfunction with ejection fraction (EF) <50%, or severe cardiac arrhythmia;
- Any arterial thromboembolic event within the past 6 months, including myocardial infarction, unstable angina, cerebrovascular accident, or transient ischemic attack;
- Active hepatitis B or hepatitis C infection;
- History of stroke or intracranial hemorrhage within the past 6 months;
- Known history of human immunodeficiency virus (HIV) positivity.
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
Xuzhou Children's Hospital
Xuzhou, Jiangsu, 221000
Shuhong Shen, 18930830638 ext. +86, shenshuhong@scmc.com.cn
About this study
Official title: A Prospective, Multicenter, Randomized Controlled Clinical Study of Camrelizumab in Combination With Ivarmacitinib as First-line Treatment for Pediatric Classical Hodgkin Lymphoma
A prospective, multicenter, randomized controlled clinical study of camrelizumab in combination with ivarmacitinib as first-line treatment for pediatric classical Hodgkin lymphoma
Read the detailed description
A prospective, multicenter, randomized controlled clinical study of camrelizumab in combination with ivarmacitinib as first-line treatment for pediatric classical Hodgkin lymphoma
- Conditions
- Hodgkin Lymphoma
- Being tested
- PD-1+JAK1i, PD-1
- Medical subject headings
- Hodgkin Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PD-1+JAK1iDrug
PD-1 inhibitor: 3 mg/kg, IV, D1, 22; JAK1i: 4mg/m2, PO, QD, D1-35;
PD-1Drug
PD-1 inhibitor: 3 mg/kg, IV, D1, 22;
| Study group | Role | What they receive |
|---|---|---|
| PD-1+JAK1i | Experimental | PD-1+JAK1i (+AVD) Receives: Drug: PD-1+JAK1i |
| PD-1 | Active comparator | PD-1 (+AVD) Receives: Drug: PD-1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete Metabolic Response，CMR
Measured: Up to 7 weeks（After the end of the 1st cycle PD-1 ± JAKi treatment period）
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2026
- Study start30 Jun 2026 (estimated)
- Primary completion30 Sep 2028 (estimated)
- Study completion30 Sep 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hodgkin LymphomaStudies of the same condition, open and under way.
- More trials run by Shanghai Jiao Tong University School of MedicineThe 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 112 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Jiao Tong University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shuhong Shen, Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07641010
- Sponsor's protocol ID
- MA-HL-II-002
- Status last verified
- Jun 2026
- First submitted
- 5 Jun 2026
- Last updated
- 11 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter, Randomized Controlled Clinical Study of Camrelizumab in Combination With Ivarmacitinib as First-line Treatment for Pediatric Classical Hodgkin Lymphoma
- ClinicalTrials.gov ID
- NCT07641010
- Acronym / sponsor ID
- MA-HL-II-002
- Conditions
- Hodgkin Lymphoma
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 112 participants (estimated)
- Lead sponsor
- Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- 30 Jun 2026 (estimated)
- Primary completion
- 30 Sep 2028 (estimated)
- Study completion
- 30 Sep 2030 (estimated)
- First posted
- 11 Jun 2026 (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.
A prospective, multicenter, randomized controlled clinical study of camrelizumab in combination with ivarmacitinib as first-line treatment for pediatric classical Hodgkin lymphoma
Detailed description
A prospective, multicenter, randomized controlled clinical study of camrelizumab in combination with ivarmacitinib as first-line treatment for pediatric classical Hodgkin lymphoma
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PD-1+JAK1i | Experimental | Drug: PD-1+JAK1iPD-1+JAK1i (+AVD) |
| PD-1 | Active comparator | Drug: PD-1PD-1 (+AVD) |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (16 listed)
- Age 6-18 years, male or female;
- Histologically confirmed classic Hodgkin lymphoma;
- Newly diagnosed, previously untreated patients;
- Subjects must have at least one measurable lesion, defined as: a lymph node lesion with the longest diameter >1.5 cm on CT cross-sectional imaging; or an extranodal lesion with the longest diameter >1.0 cm;
- ECOG performance status (PS) 0-2;
Key exclusion criteria (12 listed)
- Histopathologically confirmed nodular lymphocyte-predominant Hodgkin lymphoma (NLPHL);
- Prior anti-tumor therapy for classic Hodgkin lymphoma (cHL);
- Patients with central nervous system (CNS) involvement by lymphoma;
- Inability to swallow oral medication, or any other factor affecting oral drug administration and absorption;
- Presence of any active, known, or suspected autoimmune disease (subjects who are in a stable condition and do not require systemic immunosuppressive therapy are permitted to enroll);
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 |
|---|---|---|
| PD-1+JAK1iPD-1 inhibitor: 3 mg/kg, IV, D1, 22; JAK1i: 4mg/m2, PO, QD, D1-35; | Drug | PD-1+JAK1i |
| PD-1PD-1 inhibitor: 3 mg/kg, IV, D1, 22; | Drug | PD-1 |
Primary outcome
Complete Metabolic Response，CMR
Time frame: Up to 7 weeks（After the end of the 1st cycle PD-1 ± JAKi treatment period）
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 11 Jun 2026.
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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 1/2 study testing PD-1+JAK1i and PD-1 in people with Hodgkin Lymphoma, run by Shanghai Jiao Tong University School of Medicine 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 16 inclusion and 12 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: opening soon, as of the sponsor's last update on 11 Jun 2026. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 Shuhong Shen (18930830638 ext. +86, shenshuhong@scmc.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete Metabolic Response，CMR (time frame: Up to 7 weeks（After the end of the 1st cycle PD-1 ± JAKi treatment period）). 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 11 Jun 2026.