Phase II Study Of Nivolumab Plus AVD In Pediatric, Adolescent, And Young Adult Patients With CHL

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age2-21
SponsorM.D. Anderson Cancer Center

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 volunteers

Qualifiers

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

Design model

Single group

Treatments tested in this trial

  • Nivolumab

    Drug

    Given by IV

  • Doxorubicin Hydrochloride

    Drug

    Given by IV

  • Vinblastine

    Drug

    Given by IV

  • Dacarbazine

    Drug

    Given by IV

Treatment groups

15 Participants
are divided into 1 treatment group
Group A: Phase II: Treatment with Nivolumab + AVDExperimental treatment 4 interventions

Trial outcomes

Primary outcomes

1

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

Time frame
Through study completion; an average of 1 year

Secondary outcomes

Other outcomes

Sponsors and contacts

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