RecruitingPhase 2NCT06984146

Nivo40-AVD for Advanced Classic Hodgkin Lymphoma

Flat-dose Nivolumab (40 mg) in Combination With Doxorubicin, Vinblastine, and Dacarbazine (AVD) for Newly Diagnosed Advanced Classic Hodgkin Lymphoma


Sponsor

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

Enrollment

54 participants

Start Date

Apr 15, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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

Min Age: 18 Years

Inclusion Criteria5

  • 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%
  • ECOG 0-4

Exclusion Criteria4

  • 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

Interventions

DRUGNivolumab

40 mg day 1 and 15

DRUGDoxorubicin

25 mg/m2 day 1 and 15

DRUGVinblastine

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

DRUGDacarbazine

375 mg/m2 day 1 and 15


Locations(1)

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

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NCT06984146


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