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

NCT06831370 | Recruiting Phase 4

• 1 other identifier: C25030
• Study Type: interventional
• Target: 124
• Locations: 1 country
• Sites: 11

Brief 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.

Conditions

Hodgkin Lymphoma

Keywords

Lymphoma; Chemotherapy

Outcome Measures

Primary Outcomes (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.

  Up to 40 weeks

Secondary Outcomes (9)

• Percentage of Participants Achieving Complete Remission (CR)

  Up to 35 weeks

• Objective Response Rate (ORR)

  Up to 35 weeks

• Positron Emission Tomography (PET) Negativity Rate at Cycle 2

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

• Progression Free Survival (PFS)

  Up to 40 weeks

• Overall Survival (OS)

  Up to 40 weeks

Study Arms (1)

Brentuximab Vedotin 1.2 mg/kg

EXPERIMENTAL

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.

Drug: Brentuximab Vedotin; Drug: Doxorubicin; Drug: Vinblastine; Drug: Dacarbazine

Interventions

Brentuximab Vedotin DRUG

Brentuximab Vedotin IV infusion

Also known as: Adcetris

Brentuximab Vedotin 1.2 mg/kg

Doxorubicin DRUG

Doxorubicin IV infusion

Also known as: Adriamycin

Brentuximab Vedotin 1.2 mg/kg

Vinblastine DRUG

Vinblastine IV infusion

Brentuximab Vedotin 1.2 mg/kg

Dacarbazine DRUG

Dacarbazine IV infusion

Brentuximab Vedotin 1.2 mg/kg

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• 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:

You may not qualify if:

• 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.
• 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%

Sponsors & Collaborators

• Takeda: lead

Study Sites (11)

HCG City Cancer Centre

Vijayawada, Andhra Pradesh, 520002, India

RECRUITING

Gauhati Medical college and Hospital

Guwahati, Assam, 781032, India

ACTIVE NOT RECRUITING

Unique Hospital Multispeciality and Research Institute

Surat, Gujarat, 395002, India

RECRUITING

HCG Cancer Centre

Bangalore, Karnataka, 560027, India

RECRUITING

JIPMER

Puducherry, Kerala, 605006, India

ACTIVE NOT RECRUITING

HCG Manavata Cancer Centre

Nashik, Maharashtra, 422002, India

ACTIVE NOT RECRUITING

ACTREC

Navi Mumbai, Maharashtra, 410210, India

ACTIVE NOT RECRUITING

DMH

Pune, Maharashtra, 411004, India

ACTIVE NOT RECRUITING

Rajiv Gandhi Cancer Hospital

Delhi, New Delhi, 110085, India

ACTIVE NOT RECRUITING

NRS Medical college & Hospital, Kolkata

Kolkata, West Bengal, 700014, India

RECRUITING

AIIMS

New Delhi, 110029, India

RECRUITING

Related Links

• Click here for more information about this trial in easy-to-understand language, including a Plain Language Summary of the results if the trial has been completed.
• Click here to ask Takeda's chatbot for comprehensive and easy-to-understand information about clinical trials - even across products and indications - in your local language.

MeSH Terms

Conditions

Hodgkin Disease; Lymphoma

Interventions

Brentuximab Vedotin; Doxorubicin; Vinblastine; Dacarbazine

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Oligopeptides; Peptides; Amino Acids, Peptides, and Proteins; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Serum Globulins; Globulins; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines; Triazenes; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring

Central Study Contacts

Takeda Contact

CONTACT

+1-877-825-3327; medinfoUS@takeda.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 14, 2025
• First Posted: February 18, 2025
• Study Start: August 28, 2024
• Primary Completion (Estimated): March 31, 2028
• Study Completion (Estimated): March 31, 2028
• Last Updated: February 23, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Access Criteria: IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/ For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.

Locations

IN (11)