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CTRI Number  CTRI/2013/08/003921 [Registered on: 27/08/2013] Trial Registered Prospectively
Last Modified On: 20/01/2021
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Biological 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A clinical trial to study the effects of Rituximab injection (Hetero) in Indian patients suffering from varieties of Non-Hodgkins Lymphoma. 
Scientific Title of Study   A Randomized, Multiple-dose, Multicenter, Comparative Parallel Study To Evaluate The Efficacy, Safety And Pharmacokinetic Characteristics Of Intravenous Infusion Of Rituximab (Hetero) And Reference Medicinal Product (Rituximab, Roche) In Indian Patients Of Non-Hodgkins Lymphoma (HERILY Study) 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
HCR/III/Ritux/06/2012 Version 1.1 dated 01Nov2012  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name   
Designation   
Affiliation   
Address 




 
Phone    
Fax    
Email    
 
Details of Contact Person
Scientific Query  
Name  Dr Shubhadeep Sinha MD 
Designation  Associate Vice-President and Head 
Affiliation  Hetero Group 
Address  Clinical Development and Medical Affairs, Hetero Drugs Limited, “Hetero Corporate”,7-2-A2, Industrial Estates, Sanath Nagar, Hyderabad- 500018, India

Hyderabad
ANDHRA PRADESH
500018
India 
Phone  91-40-23704923  
Fax  91-40-23801902  
Email  sd.sinha@heterodrugs.com  
 
Details of Contact Person
Public Query
Modification(s)  
Name  Dr Rudolph Julius D Almeida  
Designation  Project Manager  
Affiliation  Hetero Drugs Ltd 
Address  Clinical Development and Medical Affairs, Hetero Drugs Limited, “Hetero Corporate”,7-2-A2, Industrial Estates, Sanath Nagar, Hyderabad- 500018, India

Hyderabad
ANDHRA PRADESH
500018
India 
Phone  91-40-23704923  
Fax  91-40-23801902  
Email  rudolph.a@heterodrugs.com  
 
Source of Monetary or Material Support  
Hetero Drugs Limited, Unit – III, Biologics Division, Survey no. 458, APIIC Pharma SEZ, Polepally (v), Jadcherla (m), Mahaboobnagar – 509301, A.P, India.  
 
Primary Sponsor  
Name  Hetero Drugs Limited 
Address  “Hetero Corporate”, 7-2-A2, Industrial Estates, Sanath Nagar, Hyderabad- 500018, India  
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 36  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Dipti Rani Samanta MD  Acharya Harihar Regional Cancer Centre  Department of Medical Oncology, Acharya Harihar Regional Cancer Centre, Medical Road, Mangalabag, Cuttack-753007, Orissa
Cuttack
ORISSA 		 06712303780

diptiranisamanta@rediffmail.com 
Dr Surinder Beniwal MD DM  Acharya Tulsi Regional Cancer Treatment & Research Institute  Acharya Tulsi Regional Cancer Treatment & Research Institute, S.P. Medical College & Associated group of Hospitals, Bikaner-Rajasthan, India-334003
Bikaner
RAJASTHAN 		 0151-2226329
0151-2226329
beniwal.surendra@gmail.com 
Dr Prabrajya Narayana Mohapatra MD DM  Apollo Gleneagles Cancer Hospital  Department of Medical Oncology, Apollo Gleneagles Cancer Hospital, 58, Canal Circular Road, Kolkata- 700054
Kolkata
WEST BENGAL 		 033-23203040
033-23205184
prabrajya.mohapatra@rediffmail.com 
Dr Krishna Mohan DNB DM  Basavatarakam Indo American Cancer Hospital& Research Institute  Consultant Medical Oncologist, Department of Medical Oncology, Basavatarakam Indo American Cancer Hospital& Research Institute, Road No-14,Banjara hills,Hyderabad-500034, AP, India.
Hyderabad
ANDHRA PRADESH 		 040-23551235
040-23540212
mvtkm@yahoo.com 
Dr Kunjahari Medhi MD DM  Batra Hospital & Medical Research Centre  Department of oncology, Batra Hospital & Medical Research Centre, 1, Tughlakabad Institutional area, Mehrauli Badarpur Road, New Delhi-110062.
New Delhi
DELHI 		 011-29958747

medhiaiims@gmail.com 
Dr Ganesh Dev Vashista MD DM  BGS Global Hospital  Head-Medical Oncology, BGS Global Hospital, BGS Health & Education City,#67,Uttarahalli Road,Kengeri,Bangalore-560060.
Bangalore
KARNATAKA 		 080-26255555
080-26255544
ganesha1705@gmail.com 
Dr Nirmal V Raut MD DM  Bhakti Vedanta Hospital  Bhakti Vedanta Hospital, BhaktiVedanta Swami Marg, Srishti Complex, Mira Road (East),Thane-401107, Maharashtra.
Mumbai
MAHARASHTRA 		 022-28459888

drnirmalraut@gmail.com 
Dr V Satya Suresh Attili MD DM  BIBI General Hospital and Cancer Center  BIBI General Hospital and Cancer Center 16-3-991/1/C, Government Printing Press Road, Malakpet, Hyderabad-500024,
Hyderabad
ANDHRA PRADESH 		 04024528134

Sureshattili@yahoo.com 
Dr Kalyan Kusum Mukherjee MD  Chittranjan national cancer institute  Incharge-Department of Medical Oncology, Chittranjan national cancer institute, 37 S.P Mukherjee road, Kolkata-700026.
Kolkata
WEST BENGAL 		 033-24759313
033-24757606
kkmukherjee4u@hotmail.com 
Dr Gopichand Mamillapalli MS DNB MCh   City Cancer Centre  33-25-33, Ch. Venkata Krishnayya street, Suryarao Pet, Vijayawada-520002, Andhra Pradesh
Krishna
ANDHRA PRADESH 		 08662436661

mgopichand@yahoo.com 
Dr Rajnish Vasant Nagarkar MS BSS DNB MRCSEd MNAMS  Curie Manavata Cancer Center  Curie Manavata Cancer Center, Opp. Mahamarg Bus Stand, Mumbai Naka, Nasik- 422004, Maharashtra.
Nashik
MAHARASHTRA 		 0253-2592666

drraj@manavatacancercentre.com 
Dr Arun Seshachalam MD DM  Dr. GVR Cancer Institute   Dr. GVR Cancer Institute (a unit of GVN Hospital) No. 46, Singarathope Trichy-620008, Tamil Nadu
Tiruchirappalli
TAMIL NADU 		 0431-2700712

arunonco@gmail.com 
Dr Srinivasan Krishnan MD  Dr. Rai Memorial Medical Centre  Dr. Rai Memorial Medical Centre New No. 526 (Old No. 562), Century Plaza, Anna Salai, Teynampet, Chennai-600018, Tamilnadu
Chennai
TAMIL NADU 		 044-24349594

drrmmc@ymail.com 
Dr Rabindranath Ghosh MRC  Dr. Saroj Gupta Cancer Centre Welfare Home and Research Institute  Dr. Saroj Gupta Cancer Centre Welfare Home and Research Institute (SGCCWHRI),Thakurpukur, Kolkata.
Kolkata
WEST BENGAL 		 033-24532781
033-24678002
ghoshrn@yahoo.co.uk 
Dr Shekhar Gowda Patil MD DM   HCG Bangalore Institute of Oncology  HCG Towers, No. 8, P. Kalinga Rao Road, Sampangiram Nagar, Bangalore-560027, Karnataka
Bangalore
KARNATAKA 		 08040206000

spassociates6@gmail.com 
Dr Ashish M Kaushal MD DM  HCG Cancer Centre  Medical Oncologist, HCG Cancer Centre, Sola-Science City Road, Near Sola Bridge, S.G Highway, Ahmedabad-380060.
Ahmadabad
GUJARAT 		 079-30907000
079-30907103
drashish4@yahoo.co.in 
Dr Suresh H Advani MD FICP MNAMS  Jaslok Hospital & Research Centre  Director-Medical Oncology Jaslok Hospital& Research Centre, 15-Dr.G.Deshmukh Marg, Mumbai-400 026.
Mumbai
MAHARASHTRA 		 022-66573333
022-23520508
shadvani2000@yahoo.com 
Dr Minish Jain MD  KEM Hospital  KEM Hospital, Banoo Koyaji bldg, Day care centre, Rastapeth, Pune-411011
Pune
MAHARASHTRA 		 020-56037336
020-26125603
drminishjain@yahoo.in 
Dr P Ravi Mohan MD DM  King George Hospital  King George Hospital, Dept of medicine, New block, Andhra Medical College, Vizag-530002
Visakhapatnam
ANDHRA PRADESH 		 0891-2712755
0891-2714644
oncoravi@rediffmail.com 
Dr Vijay Kumar MS MCH  King George Medical University  Department of Surgical oncology, King George Medical University, Lucknow-226003, UP, India
Lucknow
UTTAR PRADESH 		 0522-2255346
0522-2257539
drvkumar2007@gmail.com 
Dr Krishna Prasad MD DM  KMC Hospital  Department of Medical Oncology, KMC Hospital, Attavar, Mangalore-575001, Karnataka
Dakshina Kannada
KARNATAKA 		 08242445858

drkrishnaprasad@gmail.com 
Dr Jayanthi MD DM  Lazarus Hospitals Limited  Medical Oncologist, Lazarus Hospitals Limited, Lakdi-ka-pul, Hyderabad- INDIA - 500004
Hyderabad
ANDHRA PRADESH 		 040-23328899
040-23321133
jayanthi_srirambhatla@yahoo.com 
Dr Meher Lakshmi MD DM  Meher Onco Care  Meher Onco Care, Opposite Maharana Pratap Function hall, Near 6 N Junction, Amberpet main Road, Amberpet,Hyderabad-500 015
Hyderabad
ANDHRA PRADESH 		 9440592569

mehercancercare@gmail.com 
Dr Sudha Sinha MD  MNJ Institute of Oncology & Regional Cancer Center  MNJ Institute of Oncology & Regional Cancer Center, red hills, Hyderabad-500004
Hyderabad
ANDHRA PRADESH 		 040-23318414
040-23314063
drsudhand35@gmail.com 
Dr Asis Mukhopadhyay MD DNB DCH  Netaji Subhash Chandra Bose Cancer Research Institute  Medical Director, Netaji Subhash Chandra Bose Cancer Research Institute, 16A Park Lane, Kolkata-700 016
Kolkata
WEST BENGAL 		 033-22291049
033-22264704
hmcwt@dataone.in 
Dr Jayanti G Patel MD DM  Nirmal Hospital  Nirmal Hospital Pvt. Ltd., Ring Road, Civil Street, Near Kadiwala School, Surat-395002, Gujarat.
Surat
GUJARAT 		 02612331999

drjpatelonco@gmail.com 
Dr Tuphan Kanti Dolai MD DNB DM   NRS Medical College & Hospital  Hematology Department, NRS Medical College & Hospital, 138, AJC Bose Road, Kolkata-700014
Kolkata
WEST BENGAL 		 033-22443213

tkdolai@hotmail.com 
Dr Boman Nariman Dhabhar MD  Prince Aly Khan Hospital  Prince Aly Khan Hospital, Aga Hall, Nesbit Road, Mazagaon, Mumbai-400010, Maharashtra
Mumbai
MAHARASHTRA 		 02223777800

drboman@hotmail.com 
Dr Lalit Varadapande MD DM   Queen’s NRI Hospital  Medical Oncologist, Queen’s NRI Hospital, Gurudwara lane, Seehtammadhara, Visakhapatnam-530013
Visakhapatnam
ANDHRA PRADESH 		 0891-2535063
0891-2533078
drlalitv@yahoo.co.in 
Dr Dinesh Bhurani MD DM  Rajiv Gandhi Cancer institute & Research Centre  Senior consultant & incharge-Heamato Oncology Unit, Rajiv Gandhi Cancer institute & Research Centre (RGCI RC), Sector - V, Rohini, Delhi - 110 085, India,
New Delhi
DELHI 		 011-47022261
011-27051670
bhurani@gmail.com 
Dr Bhavesh Parekh MD DM  Rushil Cancer and Endocrine Care  Rushil Cancer and Endocrine Care, 107, Shalibhadra Complex, Opp. Ambawadi Jain Derasar, Nr. Nehru Nagar Circle, Ambawadi, Ahmedabad-380015.
Ahmadabad
GUJARAT 		 079-26465354
079-26465400
bhaveshdm1@hotmail.com 
Dr Jitendra Kumar Singh MD  S. S. Hospital  S. S. Hospital Doctors Colony, Malahi Pakari Chowk, Kankarbagh,Patna-800020,Bihar
Patna
BIHAR 		 06123203669

drjksingh147@hotmail.com 
Dr Ghanashyam Biswas MD DM  Sparsh Hospitals & Critical Care Pvt. Ltd.  A/407, Shid Nagar, Bhubaneswar-751007, Orissa.
Khordha
ORISSA 		 0674-2540183
0674-2545860
drgbiswas@yahoo.com 
Dr CT Satheesh MD DM  Sri Venkateshwara Hospital  Sri Venkateshwara Hospital, #86 Madiwala, Hosur Main Road,Bangalore-560068, Karnataka
Bangalore
KARNATAKA 		 08064520508

svhospitalresearch@gmail.com 
Dr Kuntegowdennahalli Chinnagiriyappa Lakshmaiah MD DM  Srinivasam Cancer Care Hospitals   Srinivasam Cancer Care Hospitals India Pvt. Ltd. #236/1, Vijayashree Layout, Arekere, Bannerghatta Main Road, Bangalore 560076, Karnataka
Bangalore
KARNATAKA 		 0804209904

kcluck@gmail.com 
Dr Ross Cecil Reuben MD  St. John’s Medical College Hospital  Professor of Medicine (Hematology), St. John’s Medical College Hospital, Sarjapur Road, Bangalore-560034.
Bangalore
KARNATAKA 		 080-22065000
080-25530070
cecilross@sify.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 36  
Name of Committee  Approval Status 
AHRCC-IEC  Approved 
Axon Institutional ethics committee-Lazarus Hospital  Approved 
Axon Institutional ethics committee-Meher Onco Care  Approved 
Ethical and scientific review committee, Batra Hospital & Medical Research Centre  Approved 
Ethics committee of KEM Hospital Research centre  Approved 
Ethics committee, Netaji Subhash Chandra Bose Cancer Research Institute  Approved 
Ethics committee-Dr GVN Cancer institute  Approved 
Ethics committee-Dr Rai memorial  Approved 
Ethics committee-Nirmal hospital  Approved 
HCG Multi speciality Ethics committee  Approved 
HCG-Central ethics committee  Approved 
IEC-Bhakti  Approved 
IEC-Bibi  Approved 
IEC-City cancer centre  Approved 
IEC-Price Aly Khan  Approved 
IEC-Srinivasam cancer care hospital  Approved 
Institutional Ethics committee, Apollo Gleneagles Cancer Hospital  Approved 
Institutional Ethics committee, Basavatarakam Indo American Cancer Hospital& Research Institute  Approved 
Institutional Ethics committee, BGS Global Hospital  Approved 
Institutional Ethics committee, Chittranjan national cancer institute  Approved 
Institutional Ethics committee, Dr. Saroj Gupta Cancer Centre Welfare Home and Research Institute  Approved 
Institutional Ethics committee, Jaslok Hospital& Research Centre  Approved 
Institutional Ethics committee, NRS Medical College & Hospital  Submittted/Under Review 
Institutional Ethics committee, Queen’s NRI Hospital  Approved 
Institutional Ethics committee, St. John’s Medical College Hospital  Approved 
Institutional Ethics committee,Acharya tulsi regional cancer treatment & research institute  Approved 
Institutional Ethics committee,King George Hospital  Approved 
Institutional Ethics committee,King George Medical university,  Approved 
Institutional Ethics committee,MNJ Institute of Oncology & Regional Cancer Center  Approved 
Institutional review board, Rajiv Gandhi Cancer institute & Research Centre   Approved 
Manipal university ethics committee  Approved 
MCRI-EC  Approved 
Sangini Hospital Ethics Committee-Rushil Cancer  Approved 
Sparsh ethics committee  Approved 
Sri Venkateshwara hospital ethics committee  Approved 
SS Hospital Research  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied
Modification(s)  
Health Type  Condition 
Patients  Adult patients with newly diagnosed or previously untreated Non-Hodgkins Lymphoma, (1) ICD-10 Condition: C859||Non-Hodgkin lymphoma, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Rituximab (Hetero)   Rituximab (Hetero) 375 mg/m2 should be administered on Day 1 of each chemotherapy cycle in combination with cyclophosphamide, doxorubicin, vincristine and prednisolone (CHOP) for 6 cycles  
Comparator Agent  Rituximab (Roche)   Rituximab (Roche) 375 mg/m2 should be administered on Day 1 of each chemotherapy cycle in combination with cyclophosphamide, doxorubicin, vincristine and prednisolone (CHOP) for 6 cycles  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  • The patient willing to give written, signed, and dated informed consent to participate in the study before initiating any study related procedures
• Male or Female ≥18 years and ≤65 years of age (both inclusive)
• Histologically confirmed CD20-positive- Newly diagnosed diffuse large B-cell Non-Hodgkin’s lymphoma OR Previously untreated patients with stage III-IV follicular lymphoma in combination with chemotherapy
• Patients who are eligible for rituximab and CHOP
• Patients with at least one measurable lesion as per International Working Group Response Criteria for Malignant Lymphoma
• Adequate liver, renal, cardiac and haematological functions
• Subjects with a performance status of 0 to 2 according to the Eastern Cooperative Oncology Group (ECOG)
• Life expectancy more than six months
• No other serious illness that according to investigator might jeopardize the well-being, the safety of study subjects, the compliance to study medications and validity of data generated during the study.
 
 
ExclusionCriteria 
Details  • Hypersensitivity reactions with murine proteins or planned chemotherapy
• Diffuse lymphoma for which CHOP is not adequate therapy
• Bulky Disease (10 cm on maximum dimension) or involves 1/3 of chest diameter (on radiographic imaging)
• Need for emergency therapy such as neurologic compression syndrome
• Subjects with CNS involvement or CNS lymphoma (Diffuse large B-cell lymphoma that is primary CNS, effusional, or intravascular according to the WHO, 2008 classification)
• Patient treated with prior chemotherapy including not limited to Anthracyclines, Rituximab, anti-CD-20 therapy or autologous or allogeneic stem cell transplantation
• Any radiotherapy given for lymphoma or non-lymphoma before 30 days of planned treatment
• Symptomatic peripheral neuropathy (≥Grade 2,Common Terminology Criteria of Adverse Events [CTCAE v 4.03)
• Patients using systemic antibiotic therapy 30 days prior to screening
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Centralized 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Overall Response rate (ORR) by International Working Group (IWG) response criteria  At baseline, end of cycle 3 and 6. 
 
Secondary Outcome  
Outcome  TimePoints 
Pharmacodynamics: CD19 counts
Pharmacokinetics:Cmax, Tmax & AUC
Immunogenicity: Anti-Rituximab antibodies
Safety:Adverse events-significant clinical signs, symptoms & laboratory abnormalities during treatment  		 Pharmacodynamics:Baseline, end of cycle 3 and 6
Pharmacokinetics:Cycle 1 and 6
Immunogenicity:Baseline, end of cycle 3 and 6 
 
Target Sample Size   Total Sample Size="150"
Sample Size from India="150" 
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   30/08/2013 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary   This study is an open label, randomized, multiple-dose, parallel study to evaluate the safety and efficacy of intravenous infusion of Rituximab Test product (Hetero) and Reference product in two clinical subtypes of Non-Hodgkin’s lymphoma (DLBCL & follicular) given along with CHOP chemotherapy. The primary objective is to compare the antitumor efficacy of Hetero-Rituximab with Reference Medicinal Product (Rituximab, Roche). The secondary objectives are to evaluate safety of the patients, compare the  immunogenic potentials from baseline to the end of 3rd & 6thcycles of chemotherapy, to evaluate the pharmacokinetic characteristics at 1st & 6th cycles of chemotherapy, and compare the pharmacodynamics from baseline to the end of 3rd & 6th cycles of chemotherapy, between two formulations of Rituximab (test and reference). 
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