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

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

Treatments tested in this trial

Nivolumab
Doxorubicin
Vinblastine
Dacarbazine

Treatment groups

54 Participants

are divided into 1 treatment group

Locations

P. Hertsen Moscow Oncology Research Institute (MORI) for administrative and economic work - the branch of the FSBI "National Medical Research Radiological Centre" (NMRRC) of the Ministry of Health of the Russian Federation Moscow Russia

Sponsors and collaborators

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

Lead sponsor

Source ClinicalTrials.gov