Nivo40-AVD for Advanced Classic Hodgkin Lymphoma
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Nivolumab, Doxorubicin, Vinblastine, Dacarbazine.
- Who it may be relevant to
- Registry conditions: Hodgkin Lymphoma, Adult. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Russia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Flat-dose Nivolumab (40 mg) in Combination With Doxorubicin, Vinblastine, and Dacarbazine (AVD) for Newly Diagnosed Advanced Classic Hodgkin Lymphoma
Overview
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
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 line PD-1 inhibitor therapy. In patients achieving only partial metabolic response after 6 cycles (Deauville score ≥ 4) radiation therapy is allowed.
Interventions
- Drug Nivolumab
40 mg day 1 and 15 - Drug Doxorubicin
25 mg/m2 day 1 and 15 - Drug Vinblastine
6 mg/m2 (not exceeding 10 mg) day 1 and 15 - Drug Dacarbazine
375 mg/m2 day 1 and 15
Primary outcome measures
- Progression-free survival [Time frame: 2 years]
Secondary outcome measures (3)
- Overall survival [Time frame: 2 years]
- Complete remission and complete metabolic response [Time frame: 2 years]
- Adverse events [Time frame: 2 years]
Eligibility criteria
Inclusion criteria
- 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 criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Russia · 1 center
- P. Hertsen Moscow Oncology Research Institute (MORI) for administrative and economic work — Moscow
Identifiers
NCT: NCT06984146 · Nivo40-AVD