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Nivo40-AVD for Advanced Classic Hodgkin Lymphoma

ConditionHodgkin Lymphoma, Adult
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorNational Medical Research Radiological Centre of the Ministry of Health of Russia

About this trial

The aim of the current trial is to evaluate the efficacy and safety of flat-dose nivolumab (40 mg) in combination with AVD in the management of patients with newly diagnosed advanced classic Hodgkin Lymphoma

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Newly-diagnosed histologically verified advanced stage (IIB-IV as per GHSG) classic Hodgkin lymphoma

No past history of autoimmune disease

Age > 18 years

Ejection fraction > 50%

Disqualifiers

Organ failure (e.g. creatinine > 2x ULN; ALT or AST > 5x ULN; bilirubin > 2x ULN; hemodynamic instability; respiratory failure > Grade 1)

Uncontrolled infection

Pregnancy

Inability to sign informed consent

Trial design

Design model

Single group

Treatments tested in this trial

  • Nivolumab

    Drug

    40 mg day 1 and 15

  • Doxorubicin

    Drug

    25 mg/m2 day 1 and 15

  • Vinblastine

    Drug

    6 mg/m2 (not exceeding 10 mg) day 1 and 15

  • Dacarbazine

    Drug

    375 mg/m2 day 1 and 15

Treatment groups

54 Participants
are divided into 1 treatment group
Group A: Nivo40-AVDExperimental treatment 4 interventions

Trial outcomes

Primary outcomes

1

Progression-free survival

Time frame
2 years

Secondary outcomes

1

Overall survival

Time frame
2 years
2

Complete remission and complete metabolic response

Time frame
2 years
3

Adverse events

Time frame
2 years

Other outcomes

Sponsors and contacts

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

National Medical Research Radiological Centre of the Ministry of Health of Russia

Lead sponsor

Source ClinicalTrials.gov
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