A Study of Brentuximab Vedotin With Doxorubicin, Vinblastine and Dacarbazine in Adults With Hodgkin Lymphoma in India
NCT ID: NCT06831370
Last Updated: 2025-02-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
PHASE4
124 participants
INTERVENTIONAL
2024-08-28
2026-03-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Clinical Trial of Brentuximab Vedotin in Classical Hodgkin Lymphoma
NCT03646123
Brentuximab Vedotin and Combination Chemotherapy in Treating Older Patients With Previously Untreated Stage II-IV Hodgkin Lymphoma
NCT01476410
A Phase 1 Study of Brentuximab Vedotin Combined With Multi-Agent Chemotherapy for Hodgkin Lymphoma
NCT01060904
Brentuximab Vedotin and Nivolumab in Treating Patients With Early Stage Classic Hodgkin Lymphoma
NCT03712202
Brentuximab Vedotin with Adriamycin, Vinblastine and Dacarbazine for Patients Aged 18-59 Years with Untreated Advanced-stage Classical Hodgkin Lymphoma: a Real-life Experience
NCT06857500
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
Brentuximab Vedotin
Brentuximab Vedotin IV infusion
Doxorubicin
Doxorubicin IV infusion
Vinblastine
Vinblastine IV infusion
Dacarbazine
Dacarbazine IV infusion
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Brentuximab Vedotin
Brentuximab Vedotin IV infusion
Doxorubicin
Doxorubicin IV infusion
Vinblastine
Vinblastine IV infusion
Dacarbazine
Dacarbazine IV infusion
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Note: Participants must have histologically confirmed classical HL according to the current world health organization classification.
2. 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.
3. Male or female participants 18 years or older.
4. Eastern cooperative oncology group (ECOG) performance status less than or equal to (≤)2.
5. 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).
6. 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).
7. 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.
8. 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).
Exclusion Criteria
2. Any serious medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with the completion of treatment according to this protocol.
3. Known cerebral or meningeal disease (HL or any other etiology), including signs or symptoms of progressive multifocal leukoencephalopathy (PML).
4. Symptomatic neurologic disease compromising normal activities of daily living or requiring medications.
5. Any sensory or motor peripheral neuropathy.
6. Any active systemic viral, bacterial, or fungal infection requiring systemic antibiotics within 2 weeks prior to first study drug dose.
7. Prior immunosuppressive chemotherapy, therapeutic radiation, or any immunotherapy (e.g., immunoglobulin replacement, other monoclonal antibody therapies) within 12 weeks of first study drug dose.
8. Previously treated with brentuximab vedotin.
9. Any contraindications to the concomitant chemotherapy regimens (doxorubicin, vinblastine, and dacarbazine).
10. 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).
11. Known human immunodeficiency virus (HIV) positive.
12. Known hepatitis B surface antigen-positive, or known or suspected active hepatitis C infection.
13. 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.
14. Any of the following cardiovascular conditions or values within 6 months before the first dose of study drug:
1. A left-ventricular ejection fraction \<50%
2. Myocardial infarction within 2 years of enrollment
3. 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.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Takeda
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
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
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
C25030
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.