Hodgkin Lymphoma
Conditions
Keywords
Hodgkin Lymphoma, N-AVD, nuvolumab, BEACOPPesc, Low dose nivolumab
Brief summary
Patients in this prospective multicenter phase II study will be randomized between two first-line therapy strategies for advanced stages of cHL. In the Nivo-AVD cohort, patients will receive 2 cycles of nivolumab monotherapy followed by a switch to Nivo-AVD combination therapy (total of 6 cycles); in the Standard cohort, patients will receive therapy according to current clinical guidelines in Russian Federation for first-line therapy of cHL, which include starting first-line therapy with 2 cycles of BEACOPP-like regimens and, after assessing response after 2 courses, switching to A(B)VD or continuing with BEACOPP-like regimens
Interventions
DRUGNivo-AVD
1. Monotherapy phase - Nivolumab - 40 mg every 14 days x 2 cycles 2. Combination therapy phase - Nivo-AVD x 6 cycles Nivolumab - 40 mg every 14 days; Doxorubicin 25 mg/m2 in D1 and 15; Vinblastine 6 mg/m2 (no more than 10 mg) in D 1 and 15; Dacarbazine 375 mg/m2 in D 1 and 15;
DRUGBEACOPP-like
* BEACOPP-like regimens x 2 cycles + BEACOPP-like regimens x 4 (for patients with PR, SD by PET/CT after 2 cycles) * BEACOPP-like regimens x 2 + A(B)VD x 4 cycles (for patients with CR by PET/CT after 2 cycles)
Sponsors
St. Petersburg State Pavlov Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* Patients with newly diagnosed histologically confirmed stage IIB, III or IV classical hodgkin lymphoma who have not previously received specific therapy; * Patients with evidence of lesion extent assessed by whole-body PET/CT; * Patients aged 18-60 years; * ECOG 0-2; * Use of highly effective contraceptive methods from the moment of signing the informed consent form, throughout the study and within 6 months after receiving the last dose of the drug;
Exclusion criteria
* Severe organ failure: creatinine \> 2 norms; alanine aminotransferase, aspartate aminotransferase \> 5 norms; bilirubin\> 1.5 norms; * Respiratory failure \> grade 1 at the time of enrollment * Requirement for vasopressor support at the time of enrollment * Uncontrolled bacterial or fungal infection at the time of enrollment * Active or prior documented autoimmune disease requiring systemic treatment * Pregnancy, breastfeeding, planning pregnancy or parenthood during the study period * Hypersensitivity or allergy to study drugs * Somatic or mental pathology that does not allow to perform research procedures, including the signing of informed consent * Simultaneous use of drugs or medical devices studied in other clinical trials
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of adverse events | Up to 24 months from thetreatment start | To compare the safety of therapy use in the Nivo-AVD and Standard cohorts: analysis of the incidence, severity and spectrum of adverse events (according to CTCAE v5.0 criteria) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free survival | 12, 24 and 36 months after completion of therapy | To compare progression-free survival in the Nivo-AVD and Standard cohorts |
| Response rates | after 2 cycles of nivo and 2 cycles of Nivo-AVD (3 months from therapy initiation) and at the end of treatment (7 months from therapy initiation) and, in Standard cohorts, after 2 cycles and EOT of BEACOPPesc (2 and 6 months) | To compare the rates of objective response, complete and partial responses after 2 and 6 courses of therapy in the Nivo-AVD and Standard cohorts by whole-body PET-CT (according to Lugano criteria for chemotherapy and LYRIC criteria for immunochemotherapy) |
| Overall survival | 12, 24, and 36 months after completion of therapy | \- To compare overall survival at 12, 24, and 36 months after completion of therapy in the Nivo-AVD and Standard cohorts. |
Countries
Russia
Contacts
CONTACTLiudmila Fedorova, MD, PhD
CONTACTPolina Kotseliabina, MD
STUDY_CHAIRNatalia Mikhailova, MD, PhD
St. Petersburg State Pavlov Medical University
Outcome results
None listed