| CTRI Number |
CTRI/2019/05/019044 [Registered on: 10/05/2019] Trial Registered Prospectively |
| Last Modified On: |
25/08/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
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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 4 version 5 dated 27-Oct-2021 |
Protocol Number |
|
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
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| Name |
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| Designation |
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| Affiliation |
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| Address |
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| Phone |
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| Fax |
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| Email |
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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 |
|
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Source of Monetary or Material Support
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| Dr. Reddy’s Laboratories S.A., Elisabethenanlage 11, CH-4051 Basel, Switzerland |
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Primary Sponsor
|
| Name |
Dr Reddys Laboratories SA |
| Address |
Elisabethenanlage 11, CH-4051 Basel, Switzerland |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
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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
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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 = 21 |
| 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 Multispeciality Hospital Limited |
Department of Medical Oncology, # 58 ,Canal Circular Road, Kolkata 700054
Kolkata
WEST BENGAL |
03323203040
prabrajya.mohapatra@rediffmail.com |
| Dr S G Raman |
Apollo Speciality Hospital |
Department of medical oncology, No 320 , Padma complex , Anna Salai , Chennai 600035
Chennai
TAMIL NADU |
4424354956
4424362424
crrt.onco@gmail.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 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 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 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 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 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 |
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Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 21 |
| Name of Committee |
Approval Status |
| Amravati Ethics Committee, Sujan Surgical Cancer Hospital & Amravati Cancer Foundation, |
Approved |
| Ethics Committee – Unique Hospital |
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 – Apollo Gleneagles Hospital |
Approved |
| Institutional Ethics Committee – Clinical Studies Apollo Hospital Enterprises limited |
Approved |
| Institutional Ethics Committee – Erode Cancer Centre |
Approved |
| Institutional Ethics Committee – prince Aly Hospital |
Approved |
| Institutional Ethics Committee, AIIMS Bhubaneswar |
Approved |
| Institutional Ethics Committee, Government Medical College, Calicut |
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 |
| Shettys Hospital Ethics Committee |
Approved |
| Shree Institutional Ethics Committee, Dhadiwal Hospital in Coalition with Shreeji HealthCare |
Approved |
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Regulatory Clearance Status from DCGI
Modification(s)
|
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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, |
|
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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 |
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Participant and Investigator Blinded |
Primary Outcome
Modification(s)
|
| 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. |
up to Week 28 |
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Secondary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| Progression-free survival (PFS) |
Week 52/ till progressive disease/ death |
| Overall Response Rate |
Week 12 and Week 28 |
| 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 |
| Complete Response |
As a best response up to Month 7 (Week 28) |
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Target Sample Size
Modification(s)
|
Total Sample Size="312"
Sample Size from India="66"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
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Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
20/05/2019 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
20/05/2019 |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="2"
Months="4"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
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Publication Details
|
None Yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
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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). |