PD-1 Antibody and JAK1 Inhibitor for Newly Diagnosed Pediatric Hodgikin's Lympoma

ConditionHodgkin Lymphoma

Trial statusNot yet recruiting

Trial phasePhase 1, Phase 2

Trial typeInterventional

Biological sexAll

Age6-18

SponsorShanghai Jiao Tong University School of Medicine

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

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

Treatment groups

112 Participants

are divided into 2 treatment groups

Group A: PD-1+JAK1iExperimental treatment 1 intervention

Group B: PD-1Active comparator 1 intervention

Trial outcomes

Primary outcomes

Complete Metabolic Response，CMR

Time frame

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

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Shanghai Jiao Tong University School of Medicine

Lead sponsor

Source ClinicalTrials.gov

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