CTRI/2025/07/091606 [Registered on: 24/07/2025] Trial Registered Prospectively
Last Modified On:
18/05/2026
Post Graduate Thesis
No
Type of Trial
Interventional
Type of Study
Biological
Study Design
Randomized, Parallel Group Trial
Public Title of Study
A phase III study to examine effectiveness, safety, pharmacokinetics, and immunogenicity of test brentuximab vedotin (ZRC-3318), administered in combination with chemotherapy, in patients with previously untreated stage III or IV classical Hodgkin lymphoma
Scientific Title of Study
A prospective, randomized, multicenter, comparative, double-blind, parallel group study to evaluate the efficacy, safety, pharmacokinetics, and immunogenicity of test brentuximab vedotin (ZRC-3318) with reference brentuximab vedotin (Adcetris®), in combination with chemotherapy, in patients with previously untreated stage III or IV classical Hodgkin lymphoma
Trial Acronym
NIL
Secondary IDs if Any
Secondary ID
Identifier
BREN.24.001, Ver 01 dated 08 November 2024
Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Dr Deven V Parmar
Designation
Chief Medical Officer & Head – Clinical R & D
Affiliation
Zydus Lifesciences Ltd
Address
Zydus Lifesciences Limited
Zydus Research Centre, Survey No. 396/403,
Sarkhej-Bavla National Highway No. 8A Moraiya
Ahmadabad GUJARAT 382213 India
Phone
02717665555
Fax
Email
dparmar@zydustherapeutics.com
Details of Contact Person Scientific Query
Name
Dr Kevinkumar Kansagra
Designation
Senior General Manager
Affiliation
Zydus Lifesciences Ltd
Address
Zydus Lifesciences Limited
Zydus Research Centre, Survey No. 396/403,
Sarkhej-Bavla National Highway No. 8A Moraiya
Ahmadabad GUJARAT 382213 India
Phone
02717665555
Fax
Email
kevinkumarkansagra@zyduslife.com
Details of Contact Person Public Query
Name
Dr Suchi Shah
Designation
Senior Scientist
Affiliation
Zydus Lifesciences Ltd
Address
Zydus Lifesciences Limited
Zydus Research Centre, Survey No. 396/403,
Sarkhej-Bavla National Highway No. 8A Moraiya
Ahmadabad GUJARAT 382213 India
Phone
02717665555
Fax
Email
suchi.shah@zyduslife.com
Source of Monetary or Material Support
Zydus Lifesciences Limited,Zydus Research Centre,Survey No. 396/403,Sarkhej-Bavla National Highway No. 8A Moraiya,Ahmedabad 382213, Gujarat, India
Primary Sponsor
Name
Zydus Lifesciences Limited
Address
Zydus Research Centre,Survey No. 396/403,Sarkhej-Bavla National Highway No. 8A Moraiya,Ahmedabad 382213, Gujarat, India
Department of Medical Oncology, Dr. B.R.A, I.R.C.H, All India Institute of Medical Sciences (AIIMS) Ansari Nagar, New Delhi, 110029,New Delhi,New Delhi,India-110029
New Delhi DELHI
9013000642
ajaygogia@gmail.com
Dr Akash Kumar
all india institute of medical sciences
Room No. 115, Academic Block, National cancer Institute, AIIMS- Jhajjar Campus, Village- Badsa, District-Jhajjar, Haryana, India Jhajjar HARYANA
9910850134
akashjha08@yahoo.com
Dr Mukul Aggarwal
all india institute of medical sciences
Department of Hematology, All India Institute of Medical Sciences, Ansari Nagar, New Delhi-110026-INDIA.
New Delhi DELHI
8800898282
mukulmamc@gmail.com
Dr Ashwin Philips
Amala Hospitals
Amala Hospital Rd, Amalanagar, Thrissur, Kerala 680555
Thrissur KERALA
9003635373
drashphilsmog@gmail.com
Dr Ishu Gupta
Amerix Cancer Hospital
Amerix Cancer Hospital, oppo welcome hotel, sector 19, Dwarka, Delhi, 110077
New Delhi DELHI
Clinical Trial & Research Department, Day Care Building 6th Floor Back Side 58, Canal Circular Road, Kolkata-700 054 , West Bengal, India
Kolkata WEST BENGAL
9007756054
anupamhemat@gmail.com
Dr MVT Krishna Mohan
Basavatarakam Indo American Cancer Hospital & Research Institute
asavatarakam Indo American Cancer Hospital & Research Institute,Road # 10,Banjara hills, Hyderabad 500034,Telangana, India Hyderabad TELANGANA
Oncoville Cancer hospital & research centre, No 4,80 ft. Road,7th Block, Nagarbhavi, 2nd stage, Bangalore- 560072-Karnataka- India
Bangalore KARNATAKA
8123274906
drdayananda.oncoville@gmail.com
Dr Gaurang Modi
Oncowin Cancer Centre
7th floor, HR Elanza, vikas gruh road, Nr mahalaxmi five roads, paldi, ahmedabad-380007, Gujarat, India Ahmadabad GUJARAT
9429827762
drgbm84@gmail.com
Dr Sudhir Atri
PGIMS Rohtak
Pt. B.D.Sharma Post Graduate Institute of Medical Sciences, PGIMS Rohtak, Daryao Nagar, Rohtak, Haryana 124001, India.
Rohtak HARYANA
9315895272
ssmantri74@yahoo.com
Dr Gaurav Prakash
Post Graduate Institute of medical Education and research (PGIMER)
Post Graduate Institute of medical Education and research (PGIMER) Sec-12, Chandigarh, U.T. 160012, India, 160012. Chandigarh CHANDIGARH
9914209678
drgp04@gmail.com
Dr Anshul Agarwal
PP maniya hospital
,FP-12, Paikee Subplot No. 3, Near Mamta Park Society-1, Opposite Dharuka College, Kapodara, Surat 395006, India. Surat GUJARAT
9969465723
anshul.oncology@gmail.com
Dr Dinesh Bhurani
Rajiv Gandhi Cancer Institute and Research Centre
Rajiv Gandhi Cancer Institute and Research Centre, Sir Chotu Ram Marg, Rohini Institutional Area, Sector 5, Rohini, New Delhi, Delhi, 110085
New Delhi DELHI
9971500861
bhurani@gmail.com
Dr Aditi Thanky
Rajkot Cancer Society
Rajkot Cancer Society, 1-Tirupati nagar, oppo. Nirmala convent school, Rajkot -360007, Gujarat, India
Rajkot GUJARAT
0281 2582327
aditik2008@yahoo.com
Dr Surendar Kumar Beniwal
S. P. Medical College & AG of Hospitals
"Department of Medical Oncology
S.P. Medical College & A.G. of Hospitals
Near General Medicine ICU
Bikaner, Rajasthan-334001"
Bikaner RAJASTHAN
9414370484 0151-226301 beniwal.surendra@gmail.com
Dr Shashikant Apte
Sahyadri Clinical Research & Development Centre
Unit of Sahyadri Hospitals Pvt Ltd.
33/34B, Makarand Bhave Path, Erandwane, Pune-411004.
Maharashtra, India Pune MAHARASHTRA
"14,MAR EW , NEWTOWN ,RAJARHAT,KOLKATA-700160
LDU BUILDING ROOM NUMBER-113"
Kolkata WEST BENGAL
9436523404
drdibakarpodder@gmail.com
Dr Ankit Patel
Unique Multispecialty hospital and research institute
Basement, clinical research Department, Unique hospital- Multispeciality & research institute, oppo. Of kiran motor, canal road civil hospital char rasta -sosyo circle lane, off ring road, surat-395017, Gujarat , india Surat GUJARAT
9825404204
drankitoncologist@gmail.com
Dr Satheesh CT
Spandana Oncology Centre
#919, New No.68, 28th Main Road, 9th Block, Jayanagar, Bangalore, Karnataka – 560069, India
Bangalore KARNATAKA
"Institute Ethics Committee, Room No-102, old OT Block, AIIMS, Ansari Nagar East, New Delhi -110029 "
Approved
"Institutional Ethics Commiittee, Amrita Institute of Medical Sciences Amrita Hospital Chowk,Mata Amritanandamayi Marg Sector 88 Faridabad, Faridabad Haryana - 121002 "
Approved
"Institutional ethics Committee 6th Floor, Meenakshi mission hospital and research centre, lake area, melur road Madurai,Tamil nadu -625107 "
Approved
"Institutional Ethics Committee Amala Institute of Medical Sciences Amala Nagar Thrissur, Kerala-680555 India "
Approved
"Institutional Ethics Committee Apollo Multispeccialty Hospital Limited 58, Canal Circular Road Kolkata- 700054 west Bengal, India"
Approved
"Institutional ethics committee Basavatarakam Indo American Cancer Hospital & Research Institute asavatarakam Indo American Cancer Hospital & Research Institute,Road # 10,Banjara hills, Hyderabad 500034,Telangana, India "
"Institutional Ethics Committee NRS Medical College & Hospital 138, AJC Bose Road, Kolkata 700014, West Bengal India "
Approved
"Institutional ethics Committee, BHCHRC, Jaipur Bhagvan Mahaveer cancer hospital & Research center, Javaharlal Nehru marg, Jaipur -302017 "
Approved
"Institutional ethis committee of Oncoville Cancer hospital & research centre No 4,80 ft. Road,7th Block, Nagarbhavi, 2nd stage, Bangalore- 560072-Karnataka- India "
Approved
"Institutional Review Boar,Tata Medical Center, 14, MAR E/W, Rajasthan, Newtown,Kolkata-700160"
Approved
"Institutional Review Board, Rajiv Gandhi Cancer Institute and Research Centre rohini, sector 5, rohini, Delhi-110085, India "
Approved
"Narayana Health Medical Ethics Committee Mazumdar Shaw Building, Basement- B block Narayana hrudayalaya Ltd, No. 258/A, Bommasandra Industrial Area, Anekal taluk, Bengaluru-560099, Karnataka, India"
"Sahyadri Hospitals Pvt Ltd Ethics Committee Sahyadri Clinical Research & Development Centre, Unit of Sahyadri Hospitals Pvt Ltd. 33/34B, Makarand Bhave Path, Erandwane, Pune-411004. Maharashtra, India"
Approved
"Sangini Hospital Ethics Committee c/o Sangini Hospital, First Floor, Santorini Square, B/h Abhishree Complex, Oppo. Star Bazar Lane, Satelite, Ahmedabad- 380015, Gujarat, India "
Approved
"Shree Vighnaharta Superspecialty hospital Institutional Ethics Committee. Shree Vighnaharta Superspecialty hospital, 1-22, Sn 159, Near Manjushree Gas Godown Nakane Road, Deopur Dhule, Dhule, Maharashtra-424002"
Approved
"Shri sankara cancer hospital and research centre Shri sankara cancer hospital and research centre 1st Cross, Shankara Matt Premises, Shankarapuram, 1st Cross Rd, shankarapuram, Basavanagudi, Bengaluru, Karnataka 560004"
Approved
"Swarnim Ethics Committee Netralaya Super Speciality Eye Hospital, 1st Floor Kaydee house, Oppo Gujarat Gas Parimal Garden Cross Road, Ellisbridge, Ahmedabad, Gujarat- 380006, India "
"Zenith Institutional Ethics Committee Kolhapur Institute of orthopaedic and Trauma 204, kh, 6/7, Behind Hotel Tourist, new shahupuri near CBS, Karveer kolhapur Maharashtra -416001 India "
EC of North East Heathcare Pvt Ltd Gurugram Plot No- 67/1, Opposite Panchamrut Bunglows, Near Shukan Mall, Off Science city Road, sola, Daskroi, Ahmedabad- 380060, Gujarat, India
Approved
Ethics Committee, Unique Hospital Multispeciality and Research Institute Oppo Kiran Mortor, Canal Road, Civil Hospital Char Rasta- Sosyo Circle Lane off Ring Road, Surat-395002, Gujarat, India
Approved
IEC-KCHRC, Kailash Cancer Hospital and Research Center., Muni Seva Ashram, Goraj Waghodia, Vadodara, India -391760
Approved
Institute Ethics Committee, Room No-102, old OT Block, AIIMS, Ansari Nagar East, New Delhi -110029
Approved
Institute Ethics Committee,AIIMS Old OT Block, Room Number 102, AIIMS Hospital, Ansari Nagar, New Delhi, Delhi -110029
Institutional Ethics Committee Sparsh Hospital,Sparsh hospital & critical care ltd,saheed nagar, bhubaneswar, odisha, 751007, india
Approved
Institutional ethics Committee, MVR Cancer Centre and research institute CP 13/516 BC, Vellalasseri. Rec, Poolacode, Kozhikode 673601, Kerala
Approved
MGMS Ethics Committee for Research on Human Subject. MGM Medical College and Hospital N-6, CIDCO Aurungabad, Maharashtra-431003
Approved
MNJ Institue of oncology and regional cancer centre ehics committee, MNJ Institute of oncology and regional cancer centre, red hills, Hyderabad -50004, telangana, India
Approved
Mumbai Oncocare Centre Institutional Ethics Committee (MOC IEC) 1 to 4 Floor -1st Shreepati Arcade Nana Chowk Mumbai, Mumbai suburban Maharashtra -400036, India
Approved
PP Maniya Hospital Pvt Ltd Mamta Park Society 1, Oppo Dharuka College, Kapodra, Varachha, Surat
Dose: 1.2 mg/kg
Route: Intravenous infusion
Duration: 155 days
Frequency : Every two weeks
Intervention
Test Brentuximab vedotin
Dose: 1.2 mg/kg
Route: Intravenous infusion
Duration: 155 days
Frequency : Every two weeks
Inclusion Criteria
Age From
18.00 Year(s)
Age To
75.00 Year(s)
Gender
Both
Details
1) Men or women aged greater than equal to 18 years.
2) Those who voluntarily provide written informed consent (approved by an Institutional Review Board or Institutional Ethics Committee) before any study specific procedures; this demonstrates that he or she understands the purpose and procedures of the study and is willing to participate in the study.
3) Individuals with histologically confirmed classical HL (cHL) according to the current World Health Organization Classification (nodular sclerosis, mixed cellularity, lymphocyte rich, lymphocyte depleted, or cHL, not otherwise specified [NOS]).
4) Treatment naïve patients with HL with modified Ann Arbor Stage III or IV disease (refer appendix I).
5) Those with Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
6) Those who have clinically palpable lymph node or spleen or liver or other extra nodal sites with increased FDG uptake on PET-CT as per the Lugano classification.
7) Individuals with the following laboratory results:
a. Absolute neutrophil count greater than equal to 1500 cells per mm3, unless there is documented involvement of Hodgkin’s lymphoma in the bone marrow
b. Platelet count greater than equal to 75000 cells per mm3, unless there is documented involvement of Hodgkin’s lymphoma in the bone marrow
c. Hemoglobin greater than equal to 8.0 g per dL
d. Total bilirubin less than2X upper limit of normal (ULN)
e. Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) less than equal to 5X ULN
f. Serum creatinine less than 2.0 mg per dL and/or creatinine clearance greater than 40 mL per min based on Cock croft Gault glomerular filtration rate estimation (140 age) × (weight in kg) × (0.85 if female) per (72 × serum creatinine)
ExclusionCriteria
Details
1. Participants with nodular lymphocyte predominant Hodgkin lymphoma.
2. Known cerebral or meningeal disease (HL or any other etiology), including signs or symptoms of progressive multifocal leukoencephalopathy (PML).
3. Symptomatic neurologic disease compromising normal activities of daily living or requiring medications.
4. Any motor or sensory peripheral neuropathy.
5. Any active systemic viral, bacterial, or fungal infection requiring systemic antibiotics within two weeks prior to the first dose of study drugs.
6. Prior immunosuppressive chemotherapy, therapeutic radiation, or any immunotherapy (e.g., immunoglobulin replacement, other monoclonal antibody therapies) within 12 weeks of the first dose of study drugs.
7. History of other malignancy within previous 3 years before the first dose or previously diagnosed with another malignancy and have any evidence of residual disease, except for appropriately treated carcinoma in situ of any type and non-melanoma skin carcinoma.
8. Positive Hepatitis B serology (either HBsAg or anti-HBc) or Hepatitis C serology (positive HCVAb or HCV RNA) indicative of previous or current infections.
9. Primary or secondary immunodeficiency (history or currently active), including known history of HIV infection or a positive test at screening.
10. History of 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. Any of the following cardiovascular conditions or values within 6 months before the first dose of study drugs:
a. Left ventricular ejection fraction less than equal to 50 percentage by 2D echocardiography (2D ECHO)
b. Myocardial infarction within 2 years of randomization
c. New York Heart Association (NYHA) class III or IV heart failure
d. 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
12. Receipt of any investigational drug within 30 days or five half lives (whichever is longer) prior to the first dose of study drugs or enrolment in another interventional clinical study.
13. Documented medical history of a poorly controlled/clinically significant medical condition or laboratory parameters, such as but not limited to, poorly controlled diabetes (HbA1c greater than 8 percentage despite medical treatment), active peptic ulcer disease, interstitial lung disease, blood coagulation disorders, or other relevant medical disease, such as a neurological, psychiatric, pulmonary, gastrointestinal, or endocrine disease or a history of clinically significant hematological, renal, or liver disease or any other condition that, in the opinion of the investigator, would put the patient at risk by participation in the trial or deemed by the clinician to be likely to interfere with a participant’s compliance and ability to provide informed consent, cooperate, or participate in the study, or to interfere with the interpretation of the results.
14. History of significant alcohol or drug abuse within past 1 year.
Method of Generating Random Sequence
Computer generated randomization
Method of Concealment
Centralized
Blinding/Masking
Participant, Investigator and Outcome Assessor Blinded
Primary Outcome
Outcome
TimePoints
Independently assessed objective response rate (i.e., complete response [CR] + partial response [PR]) using the Lugano classification
Day 1 to Day 155
Secondary Outcome
Outcome
TimePoints
Comparative clinical activity at week 24 between the two treatment arms by measuring progression free survival (PFS), overall survival (OS), and duration of response (DOR)
Day 1 to Day 169
Pharmacokinetic parameters of brentuximab vedotin, MMAE, and Tab in blood/plasma
Day 1 to Day 155
Immunogenicity
Day 1, Day 85 and Day 169
Treatment emergent adverse events
Day 1 to Day 169
Target Sample Size
Total Sample Size="201" Sample Size from India="201" Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials" Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials"
Phase of Trial
Phase 3
Date of First Enrollment (India)
15/09/2025
Date of Study Completion (India)
Applicable only for Completed/Terminated trials
Date of First Enrollment (Global)
Date Missing
Date of Study Completion (Global)
Applicable only for Completed/Terminated trials
Estimated Duration of Trial
Years="2" Months="0" Days="0"
Recruitment Status of Trial (Global)
Not Applicable
Recruitment Status of Trial (India)
Not Yet Recruiting
Publication Details
N/A
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
Brief Summary
This is a phase III, multicenter, randomized, double-blind, parallel comparator study to determine the efficacy, safety, pharmacokinetics, and immunogenicity of a biosimilar of brentuximab vedotin (ZRC-3318), developed by Zydus Lifesciences Limited – India, in comparison with reference brentuximab vedotin (Adcetris®), when administered in combination with chemotherapy, in patients with previously untreated stage III or IV classical Hodgkin lymphoma.
In this study, eligible participants will be enrolled in either of the following two arms:
1. Arm 1, in this arm, participants will receive test brentuximab vedotin + chemotherapy
2. Arm 2, in this arm, participants will receive reference brentuximab vedotin + chemotherapy
Test or reference brentuximab vedotin will be administered at a dose of 1.2 mg/kg (up to a maximum of 120 mg) as an intravenous infusion (over 30 minutes) every 2 weeks (Day 1 & Day 15 of each 28-day cycle with defined window period) until a maximum of 12 doses (six cycles).
Other than the difference in investigational drug molecule (test versus reference brentuximab vedotin), all other study schedules and procedures will be identical between arm 1 and arm 2.
AVD is to be administered first, in the stated order, per institutional guidelines, followed by administration of brentuximab vedotin. If an investigator needs to choose a different order of administration of study drugs, this must first be discussed with Sponsor’s medical expert. The order of administration must not change for patients of the PK evaluation arm.
Granulocyte-colony stimulating factor (G-CSF) will also be administered prophylactically during each chemotherapy cycle as per the investigator’s discretion.