NCT07641010

Brief Summary

A prospective, multicenter, randomized controlled clinical study of camrelizumab in combination with ivarmacitinib as first-line treatment for pediatric classical Hodgkin lymphoma

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
112

participants targeted

Target at P75+ for phase_1

Timeline
52mo left

Started Jun 2026

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 5, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 11, 2026

Completed
19 days until next milestone

Study Start

First participant enrolled

June 30, 2026

Expected
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2028

2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2030

Last Updated

June 11, 2026

Status Verified

June 1, 2026

Enrollment Period

2.3 years

First QC Date

June 5, 2026

Last Update Submit

June 10, 2026

Conditions

Hodgkin Lymphoma

Outcome Measures

Primary Outcomes (1)

  • Complete Metabolic Response，CMR

    Up to 7 weeks（After the end of the 1st cycle PD-1 ± JAKi treatment period）

Study Arms (2)

PD-1+JAK1i

EXPERIMENTAL

PD-1+JAK1i (+AVD)

Drug: PD-1+JAK1i

PD-1

ACTIVE COMPARATOR

PD-1 (+AVD)

Drug: PD-1

Interventions

PD-1+JAK1iDRUG

PD-1 inhibitor: 3 mg/kg, IV, D1, 22; JAK1i: 4mg/m2, PO, QD, D1-35;

PD-1+JAK1i
PD-1DRUG

PD-1 inhibitor: 3 mg/kg, IV, D1, 22;

PD-1

Eligibility Criteria

Age6 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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;
  • 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;
  • +1 more criteria

You may not qualify if:

  • 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);
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Xuzhou Children's Hospital

Xuzhou, Jiangsu, 221000, China

Location

MeSH Terms

Conditions

Hodgkin Disease

Condition Hierarchy (Ancestors)

LymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Central Study Contacts

Shuhong Shen

CONTACT

18930830638shenshuhong@scmc.com.cn

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chair of hematology oncology department of SCMC

Study Record Dates

First Submitted

June 5, 2026

First Posted

June 11, 2026

Study Start (Estimated)

June 30, 2026

Primary Completion (Estimated)

September 30, 2028

Study Completion (Estimated)

September 30, 2030

Last Updated

June 11, 2026

Record last verified: 2026-06

Locations

CN(1)