Clinical trial · Interventional
Comparison of AVD + Low-Dose Nivolumab vs. PET-Adapted BEACOPP-like in Advanced cHL
Randomized Study Comparing AVD Combined With Fixed-Dose Nivolumab Versus PET-Adapted BEACOPP-like Regimen as First-Line Treatment in Advanced Classical Hodgkin Lymphoma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hodgkin Lymphoma | Hodgkin Lymphoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| BEACOPP-like | Drug | — | UNRESOLVED |
| Nivo-AVD | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Nivo-AVD
- description
- Nivo-AVD cohort patients will receive 2 cycles of nivolumab monotherapy (40 mg) followed by Nivo-AVD combination therapy (6 cycles total)
- interventionNames
- Drug: Nivo-AVD
- type
- ACTIVE_COMPARATOR
- label
- BEACOPP-like regimes - Standard cohort
- description
- 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)
- interventionNames
- Drug: BEACOPP-like
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 60 Years
Show eligibility criteria text
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
References
Publications (0)
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