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 location...
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
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)
Sponsors
Leads: St. Petersburg State Pavlov Medical University

This content was sourced from clinicaltrials.gov