About this trial
The goal of this clinical research study is to learn if nivolumab plus AVD (doxorubicin, vinblastine, and dacarbazine) can help to control newly diagnosed early-stage non-bulky cHL in pediatric, adolescent, and young adult patients.
The safety of this drug combination will also be studied.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥ 2 year to 21 years
Newly diagnosed early-stage (I/II) non-bulky (<10cm) classical Hodgkin lymphoma
Baseline ejection fraction must be > 40%
Adequate hepatic function (direct bilirubin < 1.5x upper limit of normal (ULN) unless increase is due to Gilbert's disease or lymphoma involvement, and AST and/or ALT < 3x ULN unless considered due to lymphoma involvement, in which case direct bilirubin < 3x ULN or AST and/or ALT < 5x ULN will be considered eligible)
Disqualifiers
Patients who weigh less than 10kg
Any severe allergy to any of the drugs (Nivo-AVD)
Patients with any concurrent uncontrolled medical condition, infection, laboratory abnormality, or psychiatric illness which could place the patient at unacceptable risk of study treatment
Patients who are receiving any other cancer directed investigational agents; The use of other chemotherapeutic agents or anti-lymphoma agents is not permitted during study
Trial design
Single group
Treatments tested in this trial
Nivolumab
DrugGiven by IV
Doxorubicin Hydrochloride
DrugGiven by IV
Vinblastine
DrugGiven by IV
Dacarbazine
DrugGiven by IV
Treatment groups
Trial outcomes
Primary outcomes
Safety and Adverse Events (AEs)
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
Sponsors and contacts
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