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CTRI Number  CTRI/2014/09/004959 [Registered on: 02/09/2014] Trial Registered Prospectively
Last Modified On: 29/02/2016
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A clinical trial to compare safety and efficacy of two formulations of Rituximab, both being administered in combination with CHOP chemotherapy regimen, in patients with Diffuse Large B-Cell Lymphoma (DLBCL) 
Scientific Title of Study   A randomized, double-blind, phase III study comparing Biosimilar Rituximab (RTXM83) plus CHOP chemotherapy versus a reference Rituximab plus CHOP (R-CHOP) in patients with diffuse large b-cell lymphoma (DLBCL) given as first line. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
RTXM83-AC-01-11, Version 1.0 dated 05 Mar 12  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Chirag Shah 
Designation  Head- Clinical Trials 
Affiliation  Cliantha Research Limited 
Address  Sigma-1 Corporate, Off S.G.Highway, Bodakdev, Ahmedabad, Gujarat. 380054 India

Ahmadabad
GUJARAT
380054
India 
Phone  07966135631  
Fax  07966135641  
Email  cshah@clianthatrials.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Charu Gautam 
Designation  Associate VP – Global Clinical Operation 
Affiliation  Cliantha Research Limited 
Address  Sigma-1 Corporate, Off S.G.Highway, Bodakdev, Ahmedabad, Gujarat. 380054 India

Ahmadabad
GUJARAT
380054
India 
Phone  07966135655  
Fax  07966135641  
Email  cgautam@clianthatrials.com  
 
Details of Contact Person
Public Query
Modification(s)  
Name  Dr Chirag Shah 
Designation  Associate Director – Clinical Trials Department 
Affiliation  Cliantha Research Limited 
Address  Cliantha Research Limited Opp. Pushparaj Towers, Bodakdev, Ahmedabad – 380 054 Gujarat, India India

Ahmadabad
GUJARAT
380054
India 
Phone  07966219500  
Fax  07966219549  
Email  cshah@cliantha.in  
 
Source of Monetary or Material Support  
MABXIENCE SA 
 
Primary Sponsor  
Name  MABXIENCE SA 
Address  Yaguarón 1407 Oficina 904 C.P. 11100, Montevideo, Uruguay 
Type of Sponsor  Pharmaceutical industry-Global 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment
Modification(s)  		   Argentina
Brazil
Colombia
India
Indonesia
Mexico
Paraguay
South Africa
Venezuela (Bolivarian Republic of)
Malaysia
Philippines
Russian Federation
Thailand  
Sites of Study
Modification(s)  
No of Sites = 14  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Surender Kumar Beniwal  Acharya Tulsi Regional Cancer Treatment & Research Institute  Acharya Tulsi Regional Cancer Treatment & Research Institute, (RCC), S.P. Medical College & AG of Hospitals, Bikaner - 334003, Rajasthan
Bikaner
RAJASTHAN 		 919414370484

beniwal.surendra@gmail.com 
Dr AVS Suresh Attili  BIBI General Hospital and Cancer Centre  Department of Oncology, BIBI General Hospital and Cancer Centre, 16-3-991/1/c, Govt. printing press road, Malakpet, Hyderabad-500 024, Andhra Pradesh, India
Hyderabad
ANDHRA PRADESH 		 04424528122
04424410792
sureshattili@yahoo.com 
DrSandeep Jasuja  Birla Cancer Centre, SMS Hospital  Division of Medical Oncology, Birla Cancer Centre, SMS Hospital, JLN Marg, Jaipur-302 004, Rajasthan, India
Jaipur
RAJASTHAN 		 09660121475
01415105589
sandeepjasuja99@gmail.com 
Dr Venkatraman Radhakrishnan  Cancer Institute (WIA), Chennai  Department of Medical Oncology, Cancer Institute (WIA), Dr. Krishnamurthy Campus, No. 18, Sardar Patel Road, Adyar, Chennai-600 076, Tamilnadu, India
Chennai
TAMIL NADU 		 04422209150
04422201121
venkymd@gmail.com 
Dr V Arumugam  Guru Hospital  Guru Hospital, 4/120F, Pandi Koil Ring Road, Mattuthavani, Madurai
Madurai
TAMIL NADU 		 9842913300

anand@leszarians.com 
Dr Shibashish Bhattacharya  Health point Multispecialty Hospital   Department of Oncology, Health point Multispecialty Hospital 21 Prannath Pandit Street Kolkata-700 025, West Bengal, India
Kolkata
WEST BENGAL 		 03330375700
03324559037
shibashishbhattacharya@ymail.com 
Dr Prantar Chakrabarti  Institute of Hematology and transfusion Medicine (IHTM),  Department of Oncology, Institute of Hematology and transfusion Medicine (IHTM), 3rd floor MCH Building, Medical College Kolkata, 88- College Street, Kolkata-700 073, West Bengal, India
Kolkata
WEST BENGAL 		 03322123785
03322123785
prantar@gmail.com 
Dr Pramod Patil  Kailash Cancer Hospital and Research Centre  Kailash Cancer Hospital and Research Centre, Muni Seva Ashram, P.O. Goraj - 391760, Waghodia, Vadodara, Gujarat, India
Vadodara
GUJARAT 		 91-9427787080

pramodbpatil4@rediffmail.com 
Dr Kashi V  Meenakshi Mission Hospital & Research Centre  Meenakshi Mission Hospital & Research Centre, Lake Area, Melur Road, Madurai - 625107, Tamil Nadu, India
Madurai
TAMIL NADU 		 042524263000

kasi.nair@gmail.com 
Dr Asis Mukhopadhyay  Netaji Subhash Chandra Bose Cancer Research Institute  Department of Oncology, Netaji Subhash Chandra Bose Cancer Research Institute, 16 A Park Lane, Kolkata-700 016, West Bengal, India
Kolkata
WEST BENGAL 		 09896479790
03322264704
ncri.clinicalresearch@gmail.com 
Dr Prantar Chakrabarti  Nilratan sarkar Medical College and Hospital  Hematology Department, Nilratan sarkar Medical College and Hospital, 138 - A.J.C. Bose Road Kolkata - 700014
Kolkata
WEST BENGAL 		 03322123785

prantar@gmail.com 
Dr Vijay Ramanan  Oyster and Pearl Hospital  Deprtment of Oncology, Oyster and Pearl Hospital, 1671-75, Ganeshkhind Road, Near Hotel Pride, Shivaji Nagar, Pune-411 005, Maharashtra, India
Pune
MAHARASHTRA 		 09325315471

mvijayr@gmail.com 
Dr Dinesh Bhurani  Rajiv Gandhi Cancer Institute and Research Center  Department of Oncology, Rajiv Gandhi Cancer Institute and Research Center, Sector 5, Rohini , New Delhi-110 085, India
North
DELHI 		 01147022261
01127051670
bhurani@gmail.com 
DrD Lokanatha  Srinivasan Cancer Care Hospital  Srinivasan Cancer Care Hospital, 2636/1,2nd floor, Vijayshree, Arekere, Bannerghatta road, Bangalore - 560076, Karnataka.
Bangalore
KARNATAKA 		 09845695589
08026578557
drlok61@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 9  
Name of Committee  Approval Status 
Cancer institute Ethics Committee, Dr. Krishnamurthy Campus, Adyar, Chennai  Submittted/Under Review 
Ethics Committee of SMS Medical College and attached Hospitals, Jaipur  Submittted/Under Review 
Health Point Ethics Committee, Kolkata  Approved 
Institutional Ethics Committee IHTM Medical College Kolkata  Submittted/Under Review 
Institutional Ethics Committee, BIBI General Hospital and Cancer Centre, Hyderabad  Approved 
Institutional Review Board, Rajiv Gandhi Cancer Institute and Research Centre, New Delhi  Approved 
Netaji Subhash Chandra Bose Cancer Research Institute, Kolkata  Approved 
O & P institutional Ethics Committee, Pune  Approved 
SCCH- Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Diffuse large B-cell lymphoma (DLBCL),  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Mabthera® (Roche)  Rituximab BioSimilar RTXM83: Rituximab 10 mg/mL (9 mg/mL sodium chloride, 7.35 mg/mL sodium citrate dehydrate, 0.7 mg/mL polysorbate 80 (Tween 80), sterile water for injection, pH adjusted to 6.5). 375 mg/m2 intravenous (I.V.), every 3 weeks on Day 1 of the CHOP regimen, with a total of 6 cycles 
Intervention  Rituximab BioSimilar  Rituximab 10 mg/mL (9 mg/mL sodium chloride, 7.35 mg/mL sodium citrate dehydrate, 0.7 mg/mL polysorbate 80 (Tween 80), sterile water for injection, pH adjusted to 6.5). 375 mg/m2 intravenous (I.V.),every 3 weeks on Day 1 of the CHOP regimen, with a total of 6 cycles 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. Patients with measurable disease defined as existence of a unidimensional or bidimensional lesion greater than 2 cm in its longest diameter or malignant lymphocytosis greater than 5x109/L. Any other procedure for measurable disease in particular cases, may be allowed upon Sponsor approval.
2. Newly diagnosed patients with a confirmed pathologic diagnosis of large B cell-non-Hodgkin’s lymphoma (DLBCL) with untreated CD20+. Defined by the local Haematopathologist at the local laboratory according to WHO criteria.
3. Stage II-III or IV or stage I with bulk defined by the referring physician on the basis of the Cotswolds modification of the Ann Arbor classification.
4. Age-adjusted International Prognostic Index (IPI) score 0 or 1.
5. Age ≥18 to ≤65 years of age.
6. Performance status (Eastern Cooperative Oncology Group [ECOG]) of ≤2.
7. Written informed consent obtained before starting any study specific procedure.
8. Females of child-bearing potential must test negative on standard serum pregnancy test and must be willing to practice appropriate contraceptive methods for the duration of the study (e.g. oral contraceptive, double barrier method, intra-uterine device, intramuscular contraceptive). 
 
ExclusionCriteria 
Details  1. Life expectancy of less than three months.
2. Any other lymphoma other than CD20+ DLBCL. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Centralized 
Blinding/Masking
Modification(s)  		 Double Blind Double Dummy 
Primary Outcome  
Outcome  TimePoints 
Response Rate (RR):
Tumour responses will be assessed after 6 cycles of chemotherapy or
at the end of treatment and classified as Complete Response (CR),
Partial Response (PR), Stable Disease (SD) or Progressive Disease
(PD) according to the International Working Group criteria. 		 Response Rate (RR):
Tumour responses will be assessed after 6 cycles of chemotherapy or
at the end of treatment and classified as Complete Response (CR),
Partial Response (PR), Stable Disease (SD) or Progressive Disease
(PD) according to the International Working Group criteria. 
 
Secondary Outcome  
Outcome  TimePoints 
Event Free Survival: Time to progressive disease under therapy, the events for which being: progressive disease, no achievement of CR, PR associated with treatment in excess of that per protocol, SD, relapse after achievement of CR, death from any cause,
whichever comes first.
Safety : AEs will be collected during the study and up to 30 days after the end of study treatment (graded according to the NCICTC
criteria [v 4.0]). 		 At the End of study.  
 
Target Sample Size
Modification(s)  		 Total Sample Size="250"
Sample Size from India="100" 
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)
Modification(s)  		 19/09/2014 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  01/07/2013 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Open to Recruitment 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   None 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary   A randomized, double-blind, phase III study comparing Biosimilar Rituximab (RTXM83) plus CHOP chemotherapy versus a reference Rituximab plus CHOP (R-CHOP) in patients with diffuse large b-cell lymphoma (DLBCL) given as first line. This study will be initiated only after obtaining the approvals of Institutional/ Independent Ethics Committee (IEC). The subjects qualifying inclusion and exclusion criteria will be invited to participate in this study voluntarily. An Independent Data Monitoring Committee (IDMC) will assess periodically the safety data and will recommend to the Sponsor whether to continue, modify or stop the trial. This decision will be based on safety considerations and/or the results of planned interim analyses following pharmacological analysis. 
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