Status:
RECRUITING
Nivo40-AVD for Advanced Classic Hodgkin Lymphoma
Lead Sponsor:
National Medical Research Radiological Centre of the Ministry of Health of Russia
Conditions:
Hodgkin Lymphoma, Adult
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 L...
Detailed Description
Patients will receive 6 cycles of Nivo40-AVD with interim and EOT PET/CT scan. Interim PET/CT will not affect clinical decisions and is done as part of the study on response predictors after first lin...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 15 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2029
Estimated Enrollment :
54 Patients enrolled
Trial Details
Trial ID
NCT06984146
Start Date
April 15 2025
End Date
January 1 2029
Last Update
November 26 2025
Active Locations (1)
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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