Actively Recruiting
A Study to Evaluate Safety and Efficacy of Brentuximab Vedotin Plus Doxorubicin, Vinblastine and Dacarbazine in Adults With Untreated Stage 3/4 Classical Hodgkin Lymphoma
Led by Takeda · Updated on 2026-02-23
124
Participants Needed
11
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of brentuximab vedotin combined with doxorubicin, vinblastine, and dacarbazine (AVD) in adults with untreated stage 3 or 4 classical Hodgkin Lymphoma. This phase 4 study focuses on how well this combination works and monitors any side effects experienced by participants. The study is open-label and involves patients from India with confirmed Hodgkin Lymphoma. Participants will receive brentuximab vedotin at a dose of 1.2 mg/kg through intravenous infusion on days 1 and 15 of each 28-day treatment cycle. Each infusion is given within one hour after receiving doxorubicin, vinblastine, and dacarbazine infusions. This treatment is provided for up to six cycles, lasting about six months in total. During the study, participants will have heart function tested by echocardiography and lung function assessed by pulmonary function tests. Researchers will review safety by tracking adverse events for up to 40 weeks and assess how well the treatment works by measuring remission rates and survival outcomes. After finishing treatment, participants will have a final health check two months later to monitor their status and overall well-being.
CONDITIONS
Brief Title
A Study of Brentuximab Vedotin With Doxorubicin, Vinblastine and Dacarbazine in Adults With Hodgkin Lymphoma in India
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older
- Treatment-nafve participants with stage 3 or 4 classical Hodgkin Lymphoma confirmed by biopsy
- Measurable disease by radiographic imaging (preferably CT scan)
- ECOG performance status of 2 or less
- Female participants must be postmenopausal, surgically sterile, or agree to use effective contraception or true abstinence during and for 6 months after treatment
- Male participants must agree to use effective barrier contraception or true abstinence during treatment and for 6 months after
- Voluntary written consent given before study procedures
- Adequate blood counts and liver and kidney function within specified limits before treatment
You will not qualify if you...
- Female participants who are breastfeeding or have a positive pregnancy test at screening or before treatment
- Serious medical or psychiatric illness that may interfere with treatment completion
- Known brain or meningeal disease, or neurological conditions affecting daily life
- Any sensory or motor peripheral neuropathy
- Active systemic infections requiring antibiotics within 2 weeks before treatment
- Prior immunosuppressive chemotherapy, radiation, or immunotherapy within 12 weeks before treatment
- Previous treatment with brentuximab vedotin
- Contraindications to the chemotherapy drugs used in this trial
- Known allergies to brentuximab vedotin or any chemotherapy components
- Known HIV infection
- Active hepatitis B or C infection
- Diagnosed or treated for another cancer within 3 years, except fully resected nonmelanoma skin cancer or carcinoma in situ
- Certain heart conditions or abnormal heart function tests within 6 months before treatment, including low ejection fraction, recent heart attack, severe heart failure, or uncontrolled heart disease
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 6 cycles of 28 days each
Participants receive intravenous infusions of Brentuximab Vedotin, Doxorubicin, Vinblastine, and Dacarbazine in 28-day cycles for up to 6 cycles.
2 visits per cycle (Days 1 and 15) for up to 6 cycles
Trial Site Locations
Total: 11 locations
1
HCG City Cancer Centre
Vijayawada, Andhra Pradesh, India, 520002
Actively Recruiting
2
Gauhati Medical college and Hospital
Guwahati, Assam, India, 781032
Active, Not Recruiting
3
Unique Hospital Multispeciality and Research Institute
Surat, Gujarat, India, 395002
Actively Recruiting
4
HCG Cancer Centre
Bangalore, Karnataka, India, 560027
Actively Recruiting
5
JIPMER
Puducherry, Kerala, India, 605006
Active, Not Recruiting
6
HCG Manavata Cancer Centre
Nashik, Maharashtra, India, 422002
Active, Not Recruiting
7
ACTREC
Navi Mumbai, Maharashtra, India, 410210
Active, Not Recruiting
8
DMH
Pune, Maharashtra, India, 411004
Active, Not Recruiting
9
Rajiv Gandhi Cancer Hospital
Delhi, New Delhi, India, 110085
Active, Not Recruiting
10
NRS Medical college & Hospital, Kolkata
Kolkata, West Bengal, India, 700014
Actively Recruiting
11
AIIMS
New Delhi, India, 110029
Actively Recruiting
Research Team
T
Takeda Contact
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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