NCT07234487 Comparison of AVD + Low-Dose Nivolumab vs. PET-Adapted BEACOPP-like in Advanced cHL
| NCT ID | NCT07234487 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | St. Petersburg State Pavlov Medical University |
| Condition | Hodgkin Lymphoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 178 participants |
| Start Date | 2024-10-14 |
| Primary Completion | 2029-10 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 178 participants in total. It began in 2024-10-14 with a primary completion date of 2029-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
Eligibility Criteria
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
Contact & Investigator
Natalia Mikhailova, MD, PhD
STUDY CHAIR
St. Petersburg State Pavlov Medical University
Frequently Asked Questions
Who can join the NCT07234487 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 60 Years, studying Hodgkin Lymphoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07234487 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07234487 currently recruiting?
Yes, NCT07234487 is actively recruiting participants. Contact the research team at md.FedorovaL@gmail.com for enrollment information.
Where is the NCT07234487 trial being conducted?
This trial is being conducted at Moscow, Russia, Moscow, Russia, Saint Petersburg, Russia.
Who is sponsoring the NCT07234487 clinical trial?
NCT07234487 is sponsored by St. Petersburg State Pavlov Medical University. The principal investigator is Natalia Mikhailova, MD, PhD at St. Petersburg State Pavlov Medical University. The trial plans to enroll 178 participants.