Hodgkin Lymphoma, Adult
Conditions
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 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
DRUGDoxorubicin
25 mg/m2 day 1 and 15
DRUGVinblastine
6 mg/m2 (not exceeding 10 mg) day 1 and 15
DRUGNivolumab
40 mg day 1 and 15
DRUGDacarbazine
375 mg/m2 day 1 and 15
Sponsors
National Medical Research Radiological Centre of the Ministry of Health of Russia
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Newly-diagnosed histologically verified advanced stage (IIB-IV as per GHSG) classic Hodgkin lymphoma 2. No past history of autoimmune disease 3. Age \> 18 years 4. Ejection fraction \> 50% 5. ECOG 0-4
Exclusion criteria
1. Organ failure (e.g. creatinine \> 2x ULN; ALT or AST \> 5x ULN; bilirubin \> 2x ULN; hemodynamic instability; respiratory failure \> Grade 1) 2. Uncontrolled infection 3. Pregnancy 4. Inability to sign informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival | 2 years |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival | 2 years |
| Complete remission and complete metabolic response | 2 years |
| Adverse events | 2 years |
Countries
Russia
Contacts
Primary ContactMobil Akhmedov, MD, PhD
Outcome results
None listed