New combo therapy aims to boost remission in hodgkin lymphoma
NCT ID NCT06831370
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This phase 4 study is testing the safety and effectiveness of brentuximab vedotin (Adcetris) combined with standard chemotherapy (doxorubicin, vinblastine, and dacarbazine) in 124 Indian adults with untreated stage 3 or 4 classical Hodgkin lymphoma. Participants will receive the treatment for about 6 months, with regular heart and lung checks. The goal is to see how well the combo works at achieving complete remission and to monitor any side effects.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- brentuximab vedotin (Adcetris) plus doxorubicin, vinblastine, and dacarbazine
- What this could lead to
- If successful, this could confirm a safe and effective treatment option for advanced Hodgkin lymphoma in Indian patients, potentially improving remission rates.
- What could go wrong
- This is a single-arm, open-label study without a comparison group, so results may be less definitive. Side effects from chemotherapy and the targeted drug are possible, and the trial is limited to Indian patients, so findings may not apply broadly.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
-
About 124 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Aug 2024
- Expected to finish
-
Mar 2028
An estimate. End dates often move.
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria 1. 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. 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 1. 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. 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.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Classical Hodgkin lymphoma are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
-
The study's own enquiry address
This study publishes an address for enquiries. See it below .
-
The places running it
5 sites. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Show contact details
Enter your email to view the contact information for this study.
Genom att skicka in godkänner du våra Användarvillkor
Study contacts
-
Contact
Email: •••••@•••••
Locations
-
ACTREC
ACTIVE_NOT_RECRUITINGNavi Mumbai, Maharashtra, 410210, India
-
AIIMS
RECRUITINGNew Delhi, 110029, India
-
DMH
ACTIVE_NOT_RECRUITINGPune, Maharashtra, 411004, India
-
Gauhati Medical college and Hospital
ACTIVE_NOT_RECRUITINGGuwahati, Assam, 781032, India
-
HCG Cancer Centre
RECRUITINGBangalore, Karnataka, 560027, India
-
HCG City Cancer Centre
RECRUITINGVijayawada, Andhra Pradesh, 520002, India
-
HCG Manavata Cancer Centre
ACTIVE_NOT_RECRUITINGNashik, Maharashtra, 422002, India
-
JIPMER
ACTIVE_NOT_RECRUITINGPuducherry, Kerala, 605006, India
-
NRS Medical college & Hospital, Kolkata
RECRUITINGKolkata, West Bengal, 700014, India
-
Rajiv Gandhi Cancer Hospital
ACTIVE_NOT_RECRUITINGDelhi, New Delhi, 110085, India
-
Unique Hospital Multispeciality and Research Institute
RECRUITINGSurat, Gujarat, 395002, India
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Double-Drug attack on Hard-to-Treat lymphomas
- PET scans guide Nivolumab-Chemo combo in relapsed hodgkin lymphoma
- Patient's own t cells engineered to hunt lymphoma in early trial
- Can early PET scans guide a gentler, more effective attack on hodgkin lymphoma?
- Can a calming drug make cord blood transplants safer?
- Can a new pill boost Immunotherapy's power against advanced tumors?