RecruitingPhase 4NCT06831370

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

Enrollment

124 participants

Start Date

Aug 28, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a chemotherapy combination — brentuximab vedotin (a targeted drug) together with doxorubicin, vinblastine, and dacarbazine — in adults with advanced classical Hodgkin lymphoma in India. Hodgkin lymphoma is a cancer of the lymphatic system, and this treatment has shown promise in other countries; the study aims to confirm its effectiveness and safety in Indian patients. **You may be eligible if...** - You are 18 years or older - You have been newly diagnosed with classical Hodgkin lymphoma (Stage 3 or 4) and have not received any treatment yet - Your diagnosis has been confirmed by a biopsy - You have at least one measurable area of disease on imaging - Your overall health level is adequate **You may NOT be eligible if...** - You have already received treatment for Hodgkin lymphoma - You are pregnant or planning to become pregnant and unwilling to use contraception - Your organ function does not meet required levels Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGBrentuximab Vedotin

Brentuximab Vedotin IV infusion

DRUGDoxorubicin

Doxorubicin IV infusion

DRUGVinblastine

Vinblastine IV infusion

DRUGDacarbazine

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

View Full Details on ClinicalTrials.gov

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NCT06831370


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