Efficacy and Tolerability of N-AVD compared to BrECADD in patients with advanced Hodgkin Lymphoma (N-BRAVE)

Prior treatment

• Previous treatment of Hodgkin lymphoma, except for corticosteroids.

Other illness

• 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.
• Active autoimmune disease.
• Presence of another malignancy in active form or diagnosed within less than 5 years after achieving complete remission.
• Uncontrolled diabetes mellitus.

Lab values

• 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.

Age

• Age below 18 years.

Other

• Inability of the patient to provide written informed consent.
• Diagnosis of non-classical Hodgkin lymphoma or composite lymphoma.
• ECOG performance status greater than 2.
• Pregnancy or breastfeeding.

• 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