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OncoMatch/Clinical Trials/NCT06831370

A Study of Brentuximab Vedotin With Doxorubicin, Vinblastine and Dacarbazine in Adults With Hodgkin Lymphoma in India

Is NCT06831370 recruiting? Yes, currently enrolling (May 2026). This Phase 4 trial studies multiple treatments including Brentuximab Vedotin and Doxorubicin for hodgkin lymphoma.

Phase 4RecruitingTakedaNCT06831370Data as of May 2026

Treatment: Brentuximab Vedotin · Doxorubicin · Vinblastine · DacarbazineThe main aim of this study is to check how safe brentuximab vedotin is in adults with untreated Hodgkin Lymphoma (HL) when given together with doxorubicin (Adriamycin), vinblastine and dacarbazine therapy ('AVD'). Another aim is to learn how well treatment of brentuximab vedotin plus AVD works. All participants will receive brentuximab vedotin plus AVD for approximately 6 months. Participants will undergo tests like Echocardiography (ECHO) and pulmonary function testing (PFT) during the study. ECHO is a test that uses ultrasound to show how the heart muscle and valves are working; PFT is a test to check how well a participant's lungs work. Each participant will undergo a final health status check 2 months after the last treatment with brentuximab vedotin plus AVD.

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Extracted eligibility criteria

Cancer type

Hodgkin Lymphoma

Disease stage

Required: Stage III, IV

Performance status

ECOG 0–2(Ambulatory, capable of self-care)

Prior therapy

No prior treatment (treatment-naive required)
Max 0 prior lines

Cannot have received: immunosuppressive chemotherapy

Prior immunosuppressive chemotherapy, therapeutic radiation, or any immunotherapy (e.g., immunoglobulin replacement, other monoclonal antibody therapies) within 12 weeks of first study drug dose

Cannot have received: therapeutic radiation

Prior immunosuppressive chemotherapy, therapeutic radiation, or any immunotherapy (e.g., immunoglobulin replacement, other monoclonal antibody therapies) within 12 weeks of first study drug dose

Cannot have received: immunotherapy

Prior immunosuppressive chemotherapy, therapeutic radiation, or any immunotherapy (e.g., immunoglobulin replacement, other monoclonal antibody therapies) within 12 weeks of first study drug dose

Cannot have received: antibody-drug conjugate (brentuximab vedotin)

Previously treated with brentuximab vedotin

Lab requirements

Blood counts

Absolute neutrophil count ≥1,000/μL (unless HL marrow involvement); Platelet count ≥75,000/μL (unless HL marrow involvement); Hemoglobin ≥8 g/dL

Kidney function

Serum creatinine <2.0 mg/dL and/or creatinine clearance >30 mL/min (Cockcroft-Gault Equation)

Liver function

Total bilirubin <1.5 x ULN unless due to Gilbert syndrome; ALT or AST <3.0 x ULN (up to 5x ULN if due to HL in liver); moderate or severe hepatic disease excluded based on Child-Pugh criteria

Cardiac function

Left-ventricular ejection fraction <50% within 6 months before first dose excluded; NYHA Class 3 or 4 heart failure excluded; evidence of current uncontrolled cardiovascular conditions (arrhythmias, CHF, angina, ECG evidence of acute ischemia or active conduction system abnormalities) excluded; myocardial infarction within 2 years of enrollment excluded

Clinical laboratory values as specified below within 7 days before the first dose of study drug: Absolute neutrophil count ≥1,000/μL unless there is known HL marrow involvement; Platelet count ≥75,000/μL unless there is known HL marrow involvement; Total bilirubin <1.5 x ULN unless due to Gilbert syndrome; ALT or AST <3.0 x ULN (up to 5x ULN if due to HL in liver); Serum creatinine <2.0 mg/dL and/or creatinine clearance >30 mL/min (Cockcroft-Gault Equation); Hemoglobin ≥8 g/dL. Moderate or severe hepatic disease patients will be excluded based upon Child-Pugh criteria. Cardiovascular: see exclusion criteria.

Structured fields extracted by AI. May contain errors — verify against the official protocol.

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