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

Sponsor
Takeda
Study ID
NCT06831370
Phase
PHASE4
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Brentuximab Vedotin — DRUG
    Brentuximab Vedotin IV infusion
  • Doxorubicin — DRUG
    Doxorubicin IV infusion
  • Vinblastine — DRUG
    Vinblastine IV infusion
  • Dacarbazine — DRUG
    Dacarbazine IV infusion

Study Details

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.

Key Dates

First listed
Feb 18, 2025
Start date
Aug 28, 2024
Status verified
Feb 2026
Primary completion
Mar 31, 2028
Completion
Mar 31, 2028

Study Design

Enrollment
124 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Brentuximab Vedotin 1.2 mg/kg
    Participants will receive 1.2 milligrams per kilogram (mg/kg) brentuximab vedotin intravenous (IV) infusion on Days 1 and 15 of each 28-day cycle, within 1 hour after completion of treatment with other agents \[25 milligrams per meter square (mg/m\^2) doxorubicin, 6 mg/m\^2 vinblastine and 375 mg/m\^2 dacarbazine IV infusions\] for a maximum of 6 cycles.

Primary Outcome Measure

Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Adverse Drug Reactions (ADRs), and Unexpected ADRs [ Time Frame: Up to 40 weeks ]

Central Contacts

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