CTRI

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CTRI Number

CTRI/2019/05/019044 [Registered on: 10/05/2019] Trial Registered Prospectively

Last Modified On:

24/08/2021

Post Graduate Thesis

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
Modification(s)

Belarus
Bosnia and Herzegovina
Bulgaria
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 = 28
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 Ravi Kumar Saxena	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 Kajal Manaharlal Shah	Gujarat Cancer and Research Institute	Department of Medical Oncology, Gujarat Cancer institute, Civil Hospital Campus, Asarwa, Ahmedabad 380016 Ahmadabad GUJARAT	7567066593 kajal.shah@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 Satheesh 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 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 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= 28
Name of Committee	Approval Status
Amravati Ethics Committee, Sujan Surgical Cancer Hospital & Amravati Cancer Foundation,	Approved
Ethics Committee – Unique Hospital	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 –Sparsh Hospital	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 – 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
Modification(s)

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 >10 mm to less than or equals to 15 mm in the longest dimension and >10 mm in the shortest dimension 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 seropositivity for or history of active viral infection with human immunodeficiency virus (HIV).
Subjects with positive serological test for hepatitis B surface antigen (HBsAg), hepatitis B core antibody (HBcAb) or hepatitis C virus (HCV) antibody can only be included in the study only if the criteria mentioned in the protocol are met.
7) Subjects who received a live vaccine within last 3 months of the first administration of study drug except vaccine against COVID-19.
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).