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New treatment option for Hodgkin Lymphoma
Official title A Study of Brentuximab Vedotin With Doxorubicin, Vinblastine and Dacarbazine in Adults With Hodgkin Lymphoma in India
ClinicalTrials.gov ID: NCT06831370
What this study is testing
What is Brentuximab Vedotin?
Brentuximab Vedotin is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for hodgkin lymphoma.
Also referred to as Adcetris.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 4: studies an already-approved treatment
- Time commitment: about 6 months
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Treatment-naïve, Hodgkin lymphoma (HL) participants with Ann Arbor Stage 3 or 4 disease. Note: Participants must have histologically confirmed...
- Participants must have bidimensional measurable disease as documented by radiographic technique (spiral computed tomography [CT] preferred) per the...
- Male or female participants 18 years or older.
- Eastern cooperative oncology group (ECOG) performance status less than or equal to (≤)2.
- Female participants who:
You likely can't join if
- Female participants who are both lactating and breastfeeding or who have a positive serum pregnancy test during the screening period or a positive...
- Any serious medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with the completion of treatment...
- 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.
See the full eligibility criteria
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- Serum creatinine must be \ 30 mL/minute (Cockcroft-Gault Equation).
- Hemoglobin must be ≥8 grams per deciliter (g/dL).
- 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...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Vijayawada, Andhra Pradesh, India
- Guwahati, Assam, India
- Surat, Gujarat, India
- Bangalore, Karnataka, India
- Puducherry, Kerala, India
- Nashik, Maharashtra, India
- Navi Mumbai, Maharashtra, India
- Pune, Maharashtra, India
- Delhi, New Delhi, India
- Kolkata, West Bengal, India
- New Delhi, India
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 6 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Vijayawada, Andhra Pradesh, India; Guwahati, Assam, India; Surat, Gujarat, India; Bangalore, Karnataka, India; Puducherry, Kerala, India; Nashik, Maharashtra, India and 5 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.