Phase 4Recruiting
A Study of Brentuximab Vedotin With Doxorubicin, Vinblastine and Dacarbazine in Adults With Hodgkin Lymphoma in India
A Multicenter, Single-arm, Open-label, Phase 4 Study to Evaluate the Safety and Efficacy of Brentuximab Vedotin Plus Doxorubicin, Vinblastine and Dacarbazine in Indian Patients With Untreated Stage 3/4 Classical Hodgkin Lymphoma
- Sponsor
- Takeda (Industry)
- Enrollment
- 124 planned
- Conditions
- Hodgkin Lymphoma
- Interventions
- Brentuximab Vedotin; Doxorubicin; Vinblastine; Dacarbazine
- Ages
- adults, older adults
- Registry
- NCT06831370
Full record on ClinicalTrials.gov
From the registry
The 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.
Primary outcomes
- Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Adverse Drug Reactions (ADRs), and Unexpected ADRs
History
Primary completion expected
Last registry update
Registered
Started