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CTRI Number  CTRI/2019/05/019044 [Registered on: 10/05/2019] Trial Registered Prospectively
Last Modified On: 16/04/2021
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A clinical trial to compare the effects of two drugs DRL_RI and MabThera® for treatment in subjects with low tumor burden of follicular lymphoma (cancer of the immune system), who were not treated earlier. 
Scientific Title of Study   A Randomised, Double-blind, Parallel-group, Phase III Study to Compare the Efficacy, Safety, and Immunogenicity of Proposed Rituximab Biosimilar (DRL_RI) with MabThera® in Subjects with Previously Untreated, Stage II-IV, Cluster of Differentiation (CD)20-Positive, Low Tumour Burden Follicular Lymphoma 
Trial Acronym  FLINTER 
Secondary IDs if Any
Modification(s)  
Secondary ID  Identifier 
2018-004223-36  EudraCT 
RI-01-006: Amendment 3 version 4 dated 04-Nov-2020  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 Annappa Kamath 
Designation  Senior Solutions Consultant Director 
Affiliation  PAREXEL International Clinical Research Private Limited 
Address  Cowrks, Coworking Spaces Pvt. Ltd. – RMZ Eco World, Ground Floor, Bay Area – Adjacent to Building 6A, Outer Ring Road, Devarabeesanahalli Village, BENGALURU, India

Bangalore
KARNATAKA
560103
India 
Phone  918067169360  
Fax  918067723001  
Email  Annappa.Kamath@parexel.com  
 
Details of Contact Person
Public Query
 
Name  Dr Annappa Kamath 
Designation  Senior Solutions Consultant Director 
Affiliation  PAREXEL International Clinical Research Private Limited 
Address  Cowrks, Coworking Spaces Pvt. Ltd. – RMZ Eco World, Ground Floor, Bay Area – Adjacent to Building 6A, Outer Ring Road, Devarabeesanahalli Village, BENGALURU, India


KARNATAKA
560103
India 
Phone  918067169360  
Fax  918067723001  
Email  Annappa.Kamath@parexel.com  
 
Source of Monetary or Material Support  
Dr. Reddy’s Laboratories S.A., Elisabethenanlage 11, CH-4051 Basel, Switzerland 
 
Primary Sponsor  
Name  Dr Reddys Laboratories SA 
Address  Elisabethenanlage 11, CH-4051 Basel, Switzerland 
Type of Sponsor  Pharmaceutical industry-Global 
 
Details of Secondary Sponsor  
Name  Address 
PAREXEL International Clinical Research Private Limited  Cowrks, Coworking Spaces Pvt. Ltd. – RMZ Eco World, Ground Floor, Bay Area – Adjacent to Building 6A, Outer Ring Road, Devarabeesanahalli Village, BENGALURU – 560103, Karnataka, INDIA  
 
Countries of Recruitment     Belarus
Bosnia and Herzegovina
Bulgaria
China
Czech Republic
Georgia
Greece
India
Italy
Poland
Republic of Korea
Romania
Russian Federation
Serbia
Spain
Turkey
Ukraine
United States of America  
Sites of Study
Modification(s)  
No of Sites = 32  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Ashutosh Panigrahi  All India Institute of Medical Sciences  Department of Hematology, Sijua, Patrapada, Bhubaneswar-751019, Odisha, India
Khordha
ORISSA 
919437147517

medonco_ashutosh@aiimsbhubaneshwar.edu.in 
Dr Mohapatra Prabrajya Narayan  Apollo Gleneagles Hospital Limited  Department of Medical Oncology, # 58 ,Canal Circular Road, Kolkata 700054
Kolkata
WEST BENGAL 
03323203040

prabrajya.mohapatra@rediffmail.com 
Dr Raja Madras Ananthanarayanan  Apollo Speciality Hospital  Department of medical oncology, No 320 , Padma complex , Anna Salai , Chennai 600035
Chennai
TAMIL NADU 
04424336119
04424329044
drmaraja@gmail.com 
Dr Ramaswamy Noorni Venkatraman  Aster DM Healthcare Ltd  Department of Hematology and Hemato-Oncology, Aster Medcity, Kochi - 682027, Kerala, India
Ernakulam
KERALA 
04846699864

drramaswamy.venkataraman@asterhospital.com 
Dr Chandre Mukesh Bhavsing  Dhadiwal hospital in coalition With Shreeji Health Care  OPD Room no - 2, Opp New CBS (Thakker’s Buzzr), Trimbak Road, Nashik-422002
Nashik
MAHARASHTRA 
9595160424

mukeshchandre@gmail.com 
Dr Kandappan Velavan  Erode Cancer Centre  Department of radiation oncology, No 1/ 393, Velavan Nagar, Thindal , Erode -638012
Erode
TAMIL NADU 
04242339704

kvels@rediffmail.com 
Dr Vinod Raina  Fortis Memorial Research Institute  Department of Medical Oncology & Haematology, Sector-44, Gurgaon-122002
Gurgaon
HARYANA 
9811680638
911244962222
Vinod.raina@fortishealthcare.com 
Dr Ravi Kumar  Gleneagles Global Hospitals  Dept of Oncology, No 6-1-1070/1 to 4, Lakdi Ka pool, Hyderabad-500004
Hyderabad
TELANGANA 
04030644444

ravikumar1960@hotmail.com 
Dr Abdul Majeed Kuruvadangal  Government Medical College, Kozhikode  Department of General Medicine, Division of Haematology and Medical Oncology, Government Medical College, Kozhikode – 673008, Kerala, India
Kozhikode
KERALA 
9447311247

majeedonco@gmail.com 
Dr Sadanand Madhav Karandikar  Grant Medical Foundation, Ruby Hall Clinic  Room No 01, 3rd Floor, Cancer Building, 40 Sassoon Road, Pune, Maharashtra, India
Pune
MAHARASHTRA 
9890281963
912066455603
skaran44@gmail.com 
Dr Akanksha Garg  Gujarat Cancer and Research Institute  Department of Medical Oncology, Gujarat Cancer institute, Civil Hospital Campus, Asarwa, Ahmedabad 380016
Ahmadabad
GUJARAT 
07922688000
07922685490
AKANKSHA.GARG@GCRIINDIA.ORG 
Dr M Gopichand  HCG City Cancer Centre  Department of medical oncology, 35-25-33, Ch Venkata Krishnayya street, Suryarao pet, Vijayawada – 520002
Krishna
ANDHRA PRADESH 
086624366681
08662430877
mgopichand@yahoo.com 
Dr Rajnish Vasant Nagarkar  HCG Manavata Cancer Centre  Department of oncology, Behind Shivang Auto, Mumbai Naka, Nashik 422002
Nashik
MAHARASHTRA 
02536661111
02536661129
drraj@cmccnasik.in 
Dr Prasad Pralhad Gunari  HCG NMR Cancer Centre  Department of Oncology, TB Road, Near Revankar Kalyana Mantap, Deshpande Nagar, Hubli- 580029
Dharwad
KARNATAKA 
9986118065

drprasadgunari@rediffmail.com 
Dr Srinivas K G  HCG-Bharath Hospital and Institute of Oncology  #438, outer Ring road, Lakshmikanth Nagar, Hebbal, Mysuru- 570017
Mysore
KARNATAKA 
08212300638

drsrinivas.kg@gmail.com 
Dr Sateesh C T  Health Care Global Enterprises  Department of medical oncology, HCG Towers, Tower 1, 1st Floor, no 08, Kalinga Rao Road, Sampangi Ram nagar , Bangalore 560027
Bangalore
KARNATAKA 
08033669999

drsatheeshct@gmail.com 
Dr Ramanan Madatha Vijay  Jehangir Clinical Development Centre Pvt Ltd  Department of Medical Oncology, Jehangir Hospital Premises, #32 Sassoon Road, Pune 411011
Pune
MAHARASHTRA 
02026059318
02026059319
VIJAYRAMANAN54@GMAIL.COM 
Dr Mukesh S  K R Hospital, Mysore Medical College and Research Institute  Department of Radiation Oncology, KR Hospital, MMRCI, Irwin Road, Devaraja Mohalla, Mysore
Mysore
KARNATAKA 
9886873788
08212520514
dal_mukl@hotmail.com 
Dr Guru Prasad Mohanty  Kailash Cancer Hospital and Research Center  Goraj, Waghodia, Vadodara – 391760
Vadodara
GUJARAT 
02668265361
02668268048
guruprasad.mohanty@greenashram.org 
Dr Subramanian Kannan  KEM Hospital Research Centre  Oncology Department and Day care, 3rd Floor, Banookoyaji Building, Sardar moodliar Road, Rasta Peth, Pune - 411011
Pune
MAHARASHTRA 
02025822561
02026065603
dockannan@gmail.com 
Dr Sudhir Singh  King Georges Medical University   Department of Radiotherapy, Shah Mina Road, Chowk, Lucknow – 226003
Lucknow
UTTAR PRADESH 
917499737814

drsudhirsaharanpur@gmail.com 
Dr Guruprasad Bhat  Mangala Hospital & Mangala Kidney Foundation  Vajra Hills, Kadri Road, Mangalore-575003
Dakshina Kannada
KARNATAKA 
08242440499
08244255925
guru02doc@yahoo.co.in 
Dr Mukul Goyal  Metro Asian Cancer Research Institute  Department of Medical Oncology, Shirpa Path, Mansarovar, Jaipur 302020
Jaipur
RAJASTHAN 
01416661234

drmukulgoyal@yahoo.in 
Dr Narayanankutty Warrier  MVR Cancer Centre & Research Institute  CP 13/516 B C, Vellalasseri, NIT (Via), Poolacode, Calicut - 673601.
Kozhikode
KERALA 
9495617585

drnkwarrier@mvrccri.co 
Dr Chakrabarti Prantar  Nil Ratan Sircar medical College and Hospital  Department of Haematology, Nil Ratan Sircar medical College and hospital , no 138 , AJC Bose road, Kolkata -700014
Kolkata
WEST BENGAL 
9433018899

prantar@gmail.com 
Dr Tapan Kumar Saikia  Prince Aly Khan Hospital  Department of Medical Oncology, Aga hall, Nesbit Road, Mazagaon, Mumbai 400010
Mumbai
MAHARASHTRA 
02223777800
02223743820
tapan.saikia@gmail.com 
Dr Tushar Vishvasrao Patil  Sahyadri Super Specialty Hospital  30-C Erandwane, Karve Road, Pune - 411004
Pune
MAHARASHTRA 
9552522556

tussipats@hotmail.com 
Dr L K Rajeev  Shettys Hospital  Department of Oncology, Plot # 11 &12 , 12th F main, Kaveri Nagar, Bommanahalli, Bangalore 560068
Bangalore
KARNATAKA 
08040943039

lkrajeev@gmail.com 
Dr Karthik S Udupa  Shirdi Saibaba Cancer Hospital and Research Center  Department of Medical Oncology, Shirdi Saibaba Cancer Hospital and Research Centre, Kasturba Medical College and Hospital, Post box 07, MAHE, Manipal - 576104
Udupi
KARNATAKA 
08212571201
08212571934
udupa.k@gmail.com 
Dr Ghanashaym Biswas  Sparsh Hospital and Critical Care Pvt Ltd  Department of medical oncology, A/407, Behind Kalyan Jewellers, Sahid Nagar, Bhubaneswar-751007.
Khordha
ORISSA 
06742540183
06742545860
drgbiswas@gmail.com 
Dr Arora Rajendrasingh Sujansingh  Sujan Surgical Cancer Hospital & Amravati Cancer Foundation  OPD Room (Oncology), 52/B Shankar Nagar Main Road, Amravati-444606, Maharashtra, India
Amravati
MAHARASHTRA 
7212671496

dr_rsarora@rediffmail.com 
Dr Tanveer Mohibbhai Maksud  Unique Hospital Multispecialty and Research Institute  4th Floor, Chemo ward, Department of Oncology, Opp Kiran motor, Near Canal Road, Civil Char Rasta, Sosyo Circle Lane, Surat 395502
Surat
GUJARAT 
9909918887

tanveermasksud@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 32  
Name of Committee  Approval Status 
Amravati Ethics Committee, Sujan Surgical Cancer Hospital & Amravati Cancer Foundation,  Approved 
Ethics Committee – Unique Hospital  Approved 
Ethics Committee of Jehangir Clinical development Centre Pvt Ltd  Approved 
Ethics Committee of KEM Hospital research centre  Approved 
GCRI /GCS Ethics Committee  Approved 
HCG - Central Ethics Committee  Approved 
HCG-BHIO Ethics Committee  Approved 
Institute Ethics Committee –HCG Curie Centre Vijayawada  Approved 
Institute Ethics Committee – MMCRI and Associated hospital  Approved 
Institute Ethics Committee –Sparsh Hospital  Approved 
Institutional Ethics Committee - Fortis Memorial Research Institute  Approved 
Institutional Ethics Committee - HCG NMR Cancer centre  Approved 
Institutional Ethics Committee – Apollo Gleneagles Hospital  Approved 
Institutional Ethics Committee – Clinical Studies Apollo Hospital Enterprises limited  Approved 
Institutional Ethics Committee – Erode Cancer Centre  Approved 
Institutional Ethics Committee – Gleneagles Global Hospital  Approved 
Institutional Ethics Committee – KGMU  Approved 
Institutional Ethics Committee – NRS Medical College and Hospital  Submittted/Under Review 
Institutional Ethics Committee – prince Aly Hospital  Approved 
Institutional Ethics Committee, AIIMS Bhubaneswar  Approved 
Institutional Ethics Committee, Aster Medcity,  Approved 
Institutional Ethics Committee, Government Medical College, Calicut   Approved 
Institutional Ethics Committee, Poona Medical Research Foundation, Ruby Hall Clinic  Approved 
Kailash Cancer and Medical Centre, Institutional Ethics Committee  Approved 
MAHE- Ethics Committee  Approved 
Manavata Clinical research Institutional Ethics Committee  Approved 
Mangala Institutional Ethics Committee  Approved 
Metro – ACRI Ethics Committee  Approved 
MVR Cancer centre & research Institute - Institute Ethics Committee  Approved 
Sahyadri Hospitals Ltd. Ethics committee, Sahyadri Clinical Research & Development Center   Approved 
Shettys Hospital Ethics Committee  Approved 
Shree Institutional Ethics Committee, Dhadiwal Hospital in Coalition with Shreeji HealthCare  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C820||Follicular lymphoma grade I, (2) ICD-10 Condition: C821||Follicular lymphoma grade II, (3) ICD-10 Condition: C823||Follicular lymphoma grade IIIa,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  DRL_rituximab (DRL_RI)  DRL_rituximab (DRL_RI) will be administered as an intravenous (i.v) infusion, at a dose of 375 mg/m2 of Body Surface Area. 
Comparator Agent  MabThera®  MabThera® will be administered as an intravenous (i.v) infusion, at a dose of 375 mg/m2 of Body Surface Area. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  1)Subject is Male or female subjects aged greater than or equals to 18 years of age.
2)Subject is histologically confirmed, Grade 1-3a, previously untreated, CD20-positive.
3)Subject has Ann Arbor Stage II to IV and ECOG status of 0 to 1.
4)Subject has Low tumor burden follicular lymphoma as per Groupe dEtude des Lymphomes Folliculaires (GELF) Criteria
5)Subject has at least 1 measurable tumor mass in 2 dimensions, and the mass must be:
a)Nodal lesion greater than 15 mm in the longest dimension; or
b)Nodal lesion greater than 10 mm to the longest dimension; dimens ion and greater than 10 mm in the shortest dimension; or
c)Extra-nodal lesion with both long and short dimensions greater than or equals to 10 mm.
6)Subject has Life expectancy greater than or equals to 3 months.
7)If female subject, then subject should be non pregnant, non lactating. 
 
ExclusionCriteria 
Details  1)Subject with prior use of rituximab or any CD20 monoclonal antibody for any reason.
2)Subjects with known hypersensitivity to rituximab or its excipients, or to proteins of murine or other foreign origin.
3)Any prior therapy for follicular lymphoma (including but not limited to chemotherapy, radiotherapy) or subjects on chronic supra-substitutive doses of systemic gluco-corticosteriods.
4)Subjects who, in the opinion of the Investigator, require additional concomitant treatment for lymphoma.
5)Evidence of histologic transformation to high grade lymphoma or diffuse large B-cell lymphoma.
6)Subjects with known sero-positivity for or history of active viral infection with human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg) positive or hepatitis B core antibody positive, hepatitis C virus (HCV) antibody positive.
7)Subjects who have received a live vaccine within last 3 months of the first administration of study drug.
8)Subjects with history or presence of a medical condition or disease that in the Investigators opinion would place the subject at an unacceptable risk for study participation.
9)Participation in any clinical study or having taken any investigational therapy (within 2 months of the first dose of study drug).
10)Women of childbearing potential who do not consent to use highly effective methods of birth control 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Centralized 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
To demonstrate the equivalent efficacy of DRL_RI and MabThera® in subjects as measured by Overall Response Rate evaluated in accordance with published response criteria for malignant lymphoma.  Week 28 
 
Secondary Outcome  
Outcome  TimePoints 
Progression-free survival (PFS)  Week 52/ till progressive disease/ death 
Overall Response Rate  Week 12 
Overall Survival  Week 52/ End of study 
Duration of response  Week 52/ End of study 
Safety, tolerability, and immunogenicity of DRL_RI and MabThera®   Week 52 
 
Target Sample Size   Total Sample Size="284"
Sample Size from India="66" 
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)   20/05/2019 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  20/05/2019 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="2"
Months="4"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Open to Recruitment 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   None Yet 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary   The primary objective of the current study is to demonstrate the equivalent efficacy of DRL_RI and MabThera® in subjects with cluster of differentiation (CD)20-positive, low tumour burden follicular lymphoma (LTB-FL) in the first-line treatment setting, as measured by overall response rate (ORR). 
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