Randomized Study Comparing AVD Combined With Fixed-Dose Nivolumab Versus PET-Adapted BEACOPP-like Regimen as First-Line Treatment in Advanced Classical Hodgkin Lymphoma
Status: Recruiting
Location: See all (3) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 60
Healthy Volunteers: f
View:
• 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;
Locations
Other Locations
Russian Federation
A.N.Bakulev Center for cardiovascular surgery of the Russian Ministry of Health
RECRUITING
Moscow
National Medical and Surgical Center named after N.I. Pirogov
RECRUITING
Moscow
St. Petersburg State Pavlov Medical University
RECRUITING
Saint Petersburg
Contact Information
Primary
Liudmila Fedorova, MD, PhD
md.FedorovaL@gmail.com
+78123386265
Backup
Polina Kotseliabina, MD
polina.kotselyabina.med@gmail.com
+78123386265
Time Frame
Start Date:2024-10-14
Estimated Completion Date:2030-10
Participants
Target number of participants:178
Treatments
Experimental: Nivo-AVD
Nivo-AVD cohort patients will receive 2 cycles of nivolumab monotherapy (40 mg) followed by Nivo-AVD combination therapy (6 cycles total)
Active_comparator: BEACOPP-like regimes - Standard cohort
In the Standard cohort, patients will receive therapy according to current clinical guidelines 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 an A(B)VD regimen (when achieving CR by PET/CT) or continuing therapy with BEACOPP-like regimens (when achieving PR,SD by PET/CT)