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Hodgkin LymphomaPhase 4NCT06831370

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

A Phase 4 study testing Brentuximab Vedotin, Doxorubicin and Vinblastine in people with Hodgkin Lymphoma, run by Takeda at 11 sites in India.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hodgkin Lymphoma
What is being tested?
Brentuximab Vedotin, Doxorubicin and Vinblastine
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
124 participants
Where
11 sitesIndia
Study dates
28 Aug 2024to 31 Mar 2028
Phase
Phase 4
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Treatment-naïve, Hodgkin lymphoma (HL) participants with Ann Arbor Stage 3 or 4 disease.
  • Note: Participants must have histologically confirmed classical HL according to the current world health organization classification.
  • Participants must have bidimensional measurable disease as documented by radiographic technique (spiral computed tomography [CT] preferred) per the international working group revised criteria for response assessment for malignant lymphoma.
  • Male or female participants 18 years or older.
  • Eastern cooperative oncology group (ECOG) performance status less than or equal to (≤)2.
  • Female participants who:
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  • Are postmenopausal for at least 1 year before the screening visit, OR
  • Are surgically sterile, OR
  • If they are of childbearing potential, agree to practice 1 highly effective method and 1 additional effective (barrier) method of contraception at the same time, from the time of signing of the informed consent form (ICF) through 6 months after the last dose of study drug, OR
  • Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the participant. (Periodic abstinence [e.g., calendar, ovulation, symptothermal, post-ovulation methods], withdrawal, spermicides only, and lactational amenorrhea are not acceptable methods of contraception. Female and male condoms should not be used together).
  • Male participants, even if surgically sterilized (i.e., status post-vasectomy), who:
  • Agree to practice effective barrier contraception during the entire study treatment period and through 6 months after the last dose of study drug, OR
  • Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the participant. (Periodic abstinence [e.g., calendar, ovulation, symptothermal, post-ovulation methods for the female partner], withdrawal, spermicides only, and lactational amenorrhea are not acceptable methods of contraception. Female and male condoms should not be used together).
  • Voluntary written consent must be given before performance of any study-related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the participant at any time without prejudice to future medical care.
  • Clinical laboratory values as specified below within 7 days before the first dose of study drug:
  • Absolute neutrophil count greater than or equal to (≥)1,000 per microliter (1,000/μL) unless there is known HL marrow involvement
  • Platelet count ≥75,000/μL unless there is known HL marrow involvement
  • Total bilirubin must be lesser than (<)1.5 x upper limit of the normal range (ULN) unless the elevation is known to be due to Gilbert syndrome.
  • Alanine Aminotransferase (ALT) or aspartate aminotransferase (AST) must be <3.0 x ULN. An AST and ALT may be elevated up to 5 times the ULN if their elevation can be reasonably ascribed to the presence of HL in liver.
  • Note: Moderate or severe hepatic disease patients will be excluded based upon Child-Pugh criteria.
  • Serum creatinine must be <2.0 milligrams per deciliter (mg/dL) and/or creatinine clearance or calculated creatinine clearance >30 mL/minute (Cockcroft-Gault Equation).
  • Hemoglobin must be ≥8 grams per deciliter (g/dL).

Who cannot join

  • Female participants who are both lactating and breastfeeding or who have a positive serum pregnancy test during the screening period or a positive pregnancy test on Day 1 before first dose of study drug.
  • Any serious medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with the completion of treatment according to this protocol.
  • Known cerebral or meningeal disease (HL or any other etiology), including signs or symptoms of progressive multifocal leukoencephalopathy (PML).
  • Symptomatic neurologic disease compromising normal activities of daily living or requiring medications.
  • Any sensory or motor peripheral neuropathy.
  • Any active systemic viral, bacterial, or fungal infection requiring systemic antibiotics within 2 weeks prior to first study drug dose.
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  • Prior immunosuppressive chemotherapy, therapeutic radiation, or any immunotherapy (e.g., immunoglobulin replacement, other monoclonal antibody therapies) within 12 weeks of first study drug dose.
  • Previously treated with brentuximab vedotin.
  • Any contraindications to the concomitant chemotherapy regimens (doxorubicin, vinblastine, and dacarbazine).
  • Known hypersensitivity to recombinant proteins, murine proteins, or to any excipient contained in the drug formulation of brentuximab vedotin or any component of doxorubicin, vinblastine, and dacarbazine (AVD).
  • Known human immunodeficiency virus (HIV) positive.
  • Known hepatitis B surface antigen-positive, or known or suspected active hepatitis C infection.
  • Diagnosed or treated for another malignancy within 3 years before the first dose or previously diagnosed with another malignancy and have any evidence of residual disease. Participants with nonmelanoma skin cancer or carcinoma in situ of any type are not excluded if they have undergone complete resection.
  • Any of the following cardiovascular conditions or values within 6 months before the first dose of study drug:
  • A left-ventricular ejection fraction <50%
  • Myocardial infarction within 2 years of enrollment
  • New York Heart Association (NYHA) Class 3 or 4 heart failure. Evidence of current uncontrolled cardiovascular conditions, including cardiac arrhythmias, congestive heart failure (CHF), angina, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities.

Trial locations and contacts

11 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Takeda Contact contact

+1-877-825-3327

medinfoUS@takeda.com

11 sites in 1 country

India11 sites, 5 recruiting

  • HCG Cancer Centre

    Bangalore, Karnataka, 560027

    Site Contact, 9482141773, drnatarajks@gmail.com

    Natraj KS

    Recruiting

  • Rajiv Gandhi Cancer Hospital

    Delhi, New Delhi, 110085

    Active, not recruiting

  • Gauhati Medical college and Hospital

    Guwahati, Assam, 781032

    Active, not recruiting

  • NRS Medical college & Hospital, Kolkata

    Kolkata, West Bengal, 700014

    Site Contact, 9874890275, tkdolai@hotmail.com

    Tuphan kanti Dolai

    Recruiting

  • HCG Manavata Cancer Centre

    Nashik, Maharashtra, 422002

    Active, not recruiting

  • ACTREC

    Navi Mumbai, Maharashtra, 410210

    Active, not recruiting

  • AIIMS

    New Delhi, 110029

    Site Contact, 9013000642, ajaygogia@gmail.com

    Ajay Gogia

    Recruiting

  • JIPMER

    Puducherry, Kerala, 605006

    Active, not recruiting

  • DMH

    Pune, Maharashtra, 411004

    Active, not recruiting

  • Unique Hospital Multispeciality and Research Institute

    Surat, Gujarat, 395002

    Site Contact, 9909918887, tanveermaksud@gmail.com

    Tanveer Maksud

    Recruiting

  • HCG City Cancer Centre

    Vijayawada, Andhra Pradesh, 520002

    Site Contact, 9611165090, drpolisetty.a@hcgel.com

    Amarnath Polishetty

    Recruiting

Other trials in India

About this study

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

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.

Being tested
Brentuximab Vedotin, Doxorubicin, Vinblastine, Dacarbazine
Keywords
Lymphoma, Chemotherapy
Medical subject headings
Hodgkin Disease, Lymphoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Brentuximab VedotinDrug

    Also called Adcetris

    Brentuximab Vedotin IV infusion

  • DoxorubicinDrug

    Also called Adriamycin

    Doxorubicin IV infusion

  • VinblastineDrug

    Vinblastine IV infusion

  • DacarbazineDrug

    Dacarbazine IV infusion

Study groups in NCT06831370
Study groupRoleWhat they receive
Brentuximab Vedotin 1.2 mg/kgExperimentalParticipants 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.
Receives: Drug: Brentuximab Vedotin; Drug: Doxorubicin; Drug: Vinblastine; Drug: Dacarbazine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Adverse Drug Reactions (ADRs), and Unexpected ADRs

    An AE is defined as any untoward medical occurrence in a clinical investigation patient administered a drug; it does not necessarily have to have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product whether or not it is related to the medicinal product. An SAE is any AE that results in death, is life-threatening, requires inpatient hospitalization or prolongation of an existing hospitalization, results in significant disability or incapacity, is a congenital anomaly/birth defect or is a medically important event. ADRs are defined as AEs which are in the investigator's opinion of causal relationship to the study treatment. An unexpected ADR is an ADR with the nature, severity, or outcome which is not consistent with summary of product characteristics.

    Measured: Up to 40 weeks

Secondary outcomes (9)

  1. Percentage of Participants Achieving Complete Remission (CR)

    CR is defined as disappearance of all the evidence of disease assessed by investigator per Revised Response Criteria for Malignant Lymphoma.

    Measured: Up to 35 weeks

  2. Objective Response Rate (ORR)

    ORR is defined as the disappearance of all evidences of a disease along with a decrease in evidences of a disease (CR+ partial remission [PR]) assessed by investigator per Revised Response Criteria for Malignant Lymphoma.

    Measured: Up to 35 weeks

  3. Positron Emission Tomography (PET) Negativity Rate at Cycle 2

    The rate of PET negativity is the percentage of participants with PET negativity (defined as Deauville score 1, 2, or 3) at the end of Cycle 2. The Deauville 5-point scoring system is a five-point scoring system for the fluorodeoxyglucose (FDG) avidity of a Hodgkin's lymphoma or non-Hodgkin's lymphoma tumor mass as seen on FDG PET scan: Score 1= No uptake above the background, Score 2= Uptake ≤ mediastinum, Score 3= Uptake > mediastinum but ≤ liver, Score 4= Uptake moderately increased compared to the liver at any site, Score 5= Uptake markedly increased compared to the liver at any site or new lesions, Score X= New areas of uptake unlikely to be related to lymphoma. In this study, scores of 1, 2, and 3 are considered to be negative and scores of 4 and 5 are considered to be positive.

    Measured: Days 20 to 28 of Cycle 2 (cycle length=28 days)

  4. Progression Free Survival (PFS)

    PFS is defined as the time from study drug assignment to disease progression (PD) or death from any cause or date of last tumor assessment if the participant did not progress or die.

    Measured: Up to 40 weeks

  5. Overall Survival (OS)

    OS is defined as the time from study drug assignment to death from any cause or last date when the participant was known to be alive.

    Measured: Up to 40 weeks

  6. Disease Free Survival

    Disease free survival is measured from the time of occurrence of disease-free state or attainment of a CR to disease recurrence or death as a result of lymphoma or acute toxicity of treatment.

    Measured: Up to 40 weeks

  7. Event Free Survival

    Event free survival (time to treatment failure) is measured from the time from study entry to any treatment failure including disease progression, or discontinuation of treatment for any reason.

    Measured: Up to 40 weeks

  8. Duration of Response (DOR)

    DOR is defined as the time from first occurrence of overall response (CR or PR whichever is recorded first) after start of study treatment until the date of disease progression or relapse.

    Measured: Up to 40 weeks

  9. Duration of Complete Remission (DOCR)

    DOCR in participants with confirmed CR is the time between first documentation of CR and PD.

    Measured: Up to 40 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Feb 2025
  2. Study start28 Aug 2024
  3. Primary completion31 Mar 2028 (estimated)
  4. Study completion31 Mar 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
124 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06831370
Sponsor's protocol ID
C25030
Status last verified
Feb 2026
First submitted
14 Feb 2025
Last updated
23 Feb 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Brentuximab Vedotin, Doxorubicin and Vinblastine in people with Hodgkin Lymphoma, run by Takeda at 11 sites in India.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 22 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 23 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in India. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Takeda Contact (+1-877-825-3327, medinfoUS@takeda.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the 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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06831370.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2026.

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