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RECRUITING
NCT06831370
PHASE4

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

Sponsor: Takeda

View on ClinicalTrials.gov

Summary

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

124

Start Date

2024-08-28

Completion Date

2028-03-31

Last Updated

2026-02-23

Healthy Volunteers

No

Interventions

DRUG

Brentuximab Vedotin

Brentuximab Vedotin IV infusion

DRUG

Doxorubicin

Doxorubicin IV infusion

DRUG

Vinblastine

Vinblastine IV infusion

DRUG

Dacarbazine

Dacarbazine IV infusion

Locations (11)

HCG City Cancer Centre

Vijayawada, Andhra Pradesh, India

Gauhati Medical college and Hospital

Guwahati, Assam, India

Unique Hospital Multispeciality and Research Institute

Surat, Gujarat, India

HCG Cancer Centre

Bangalore, Karnataka, India

JIPMER

Puducherry, Kerala, India

HCG Manavata Cancer Centre

Nashik, Maharashtra, India

ACTREC

Navi Mumbai, Maharashtra, India

DMH

Pune, Maharashtra, India

Rajiv Gandhi Cancer Hospital

Delhi, New Delhi, India

NRS Medical college & Hospital, Kolkata

Kolkata, West Bengal, India

AIIMS

New Delhi, India