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
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
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
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
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"
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).