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Efficacy and Tolerability of N-AVD compared to BrECADD in patients with advanced Hodgkin Lymphoma (N-BRAVE)
EU CTIS ID: 2026-525263-41-00
What this study is testing
To demonstrate the non-inferiority of the N-AVD regimen compared with the BrECADD regimen in terms of complete metabolic response (CMR), assessed by PET/CT, as first-line treatment in patients with advanced Hodgkin lymphoma.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Patients must meet all inclusion criteria according to the National Health Fund Drug Program B.77, points 1.1 and 1.2.2.
- ECOG performance status 0–2.
- Histologically confirmed CD30-positive, newly diagnosed classical Hodgkin lymphoma in stage IIB with risk factors (i.e. bulky disease ≥10 cm or ≥1/3 of the maximum transverse diameter of the chest, or extranodal involvement) or stage III or IV according to the Ann Arbor classification.
- Age ≥18 years.
- Written informed consent to participate in the clinical trial.
- In women of childbearing potential (WOCBP): a negative highly sensitive serum pregnancy test (β-hCG) during screening prior to randomization, and agreement to use a highly effective contraceptive method during the study treatment period and for 6 months after the last dose of protocol treatment. Women are not considered of childbearing potential if they are post-menopausal (defined as at least 12 consecutive months of spontaneous amenorrhea without another medical cause) or permanently sterile (e.g., hysterectomy, bilateral salpingectomy, bilateral oophorectomy, or bilateral tubal occlusion). In male participants of reproductive potential: agreement to use a condom during sexual intercourse and to ensure that a female partner of childbearing potential uses a highly effective contraceptive method, or to practice true sexual abstinence consistent with usual lifestyle, during the study treatment period and for 6 months after the last dose of protocol treatment
You likely can't join if
- Age below 18 years.
- Active infection with HIV, HBV, HCV, or CMV. In case of hepatitis B with positive anti-HBc antibodies, HBV DNA PCR testing and initiation of prophylactic treatment are required in consultation with an infectious disease specialist.
- Known hypersensitivity to any of the medicinal products used in the study.
- Inability of the patient to provide written informed consent.
- Active autoimmune disease.
- Diagnosis of non-classical Hodgkin lymphoma or composite lymphoma.
See the full eligibility criteria
Who can join
- Patients must meet all inclusion criteria according to the National Health Fund Drug Program B.77, points 1.1 and 1.2.2.
- ECOG performance status 0–2.
- Histologically confirmed CD30-positive, newly diagnosed classical Hodgkin lymphoma in stage IIB with risk factors (i.e. bulky disease ≥10 cm or ≥1/3 of the maximum transverse diameter of the chest, or extranodal involvement) or stage III or IV according to the Ann Arbor classification.
- Age ≥18 years.
- Written informed consent to participate in the clinical trial.
- In women of childbearing potential (WOCBP): a negative highly sensitive serum pregnancy test (β-hCG) during screening prior to randomization, and agreement to use a highly effective contraceptive method during the study treatment period and for 6 months after the last dose of protocol treatment. Women are not considered of childbearing potential if they are post-menopausal (defined as at least 12 consecutive months of spontaneous amenorrhea without another medical cause) or permanently sterile (e.g., hysterectomy, bilateral salpingectomy, bilateral oophorectomy, or bilateral tubal occlusion). In male participants of reproductive potential: agreement to use a condom during sexual intercourse and to ensure that a female partner of childbearing potential uses a highly effective contraceptive method, or to practice true sexual abstinence consistent with usual lifestyle, during the study treatment period and for 6 months after the last dose of protocol treatment
What rules you out
- Age below 18 years.
- Active infection with HIV, HBV, HCV, or CMV. In case of hepatitis B with positive anti-HBc antibodies, HBV DNA PCR testing and initiation of prophylactic treatment are required in consultation with an infectious disease specialist.
- Known hypersensitivity to any of the medicinal products used in the study.
- Inability of the patient to provide written informed consent.
- Active autoimmune disease.
- Diagnosis of non-classical Hodgkin lymphoma or composite lymphoma.
- ECOG performance status greater than 2.
- Previous treatment of Hodgkin lymphoma, except for corticosteroids.
- Pregnancy or breastfeeding.
- Presence of another malignancy in active form or diagnosed within less than 5 years after achieving complete remission.
- Uncontrolled diabetes mellitus.
- Cardiac failure NYHA class greater than II or left ventricular ejection fraction below 45%.
- Liver failure defined as bilirubin >1.5 × upper limit of normal (ULN) or AST/SGOT >5 × ULN, if not related to lymphoma involvement, and Gilbert’s syndrome.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.