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CTRI Number  CTRI/2011/12/002232 [Registered on: 14/12/2011] Trial Registered Prospectively
Last Modified On: 14/01/2020
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Biological 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study
Modification(s)  		 To study the effects of two drugs, R-TPR-017 and Mabthera® (Ristova®) in cancer patients (Non-Hodgkin’s Lymphoma) 
Scientific Title of Study
Modification(s)  		 Prospective, multi-centric, open-label, two-arm, parallel group, active-control, randomized, comparative clinical study to evaluate efficacy and safety of R-TPR-017 / MabThera®(Ristova®) in patients with Non-Hodgkins Lymphoma 
Trial Acronym   
Secondary IDs if Any
Modification(s)  
Secondary ID  Identifier 
RLS/TP/2010/07, version 6.0, dt. 8 Jan 2013  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)  
Name  Dr Prashant A Pandya 
Designation  General Manager – Clinical Research Services 
Affiliation  Reliance Life Sciences Pvt Ltd 
Address  Reliance Life Sciences Pvt Ltd Dhirubhai Ambani Life Sciences Centre R 282 TTC Area of MIDC Rabale Navi Mumbai

Thane
MAHARASHTRA
400 701
India 
Phone  02240678236  
Fax  02240678299  
Email  prashant.pandya@relbio.com  
 
Details of Contact Person
Scientific Query
Modification(s)  
Name  Dr Devi Manjula 
Designation  Medical Monitor 
Affiliation  Reliance Life Sciences Pvt Ltd 
Address  Reliance Life Sciences Pvt. Ltd. No.65-373-2, 1st Phase, 2nd Stage, BTM Layout, Bangalore

Bangalore
KARNATAKA
560076
India 
Phone  08066261116  
Fax    
Email  devi.manjula@relbio.com  
 
Details of Contact Person
Public Query  
Name  Dr Parvez Kosgi 
Designation  Head - RLS Trials 
Affiliation  Reliance Life Sciences Pvt Ltd 
Address  Reliance Life Sciences Pvt.Ltd Dhirubhai Ambani Life Sciences Centre R 282 TTC Area of MIDC Rabale Navi Mumbai

Thane
MAHARASHTRA
400 701
India 
Phone  02240678258  
Fax    
Email  Parvez.kosgi@relclin.com  
 
Source of Monetary or Material Support  
Reliance Life sciences Pvt Ltd Dhirubhai Ambani Life Sciences Centre Plot R 282 TTC Area of MIDC Thane Belapur Road Rabale Navi Mumbai 400 701. India 
 
Primary Sponsor  
Name  Reliance Life sciences Pvt Ltd 
Address  Dhirubhai Ambani Life Sciences Centre Plot R 282 TTC Area of MIDC Thane Belapur Road Rabale Navi Mumbai 400 701 India  
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 26  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr J B Sharma  Action Cancer Hospital, New Delhi  Action Cancer Hospital, A-4, Paschim Vihar, Room No 806, Clinical Research Dept, New Delhi-63
New Delhi
DELHI 		 9811167505

dr_sharmajb@rediffmail.com 
Dr Joseph Jebasingh  Asirvatham Speciality Hospital, Madurai  22 Rajaji Street, Gandhinagar, Madurai - 625020
Madurai
TAMIL NADU 		 9442619775

jjebasingh@gmail.com 
Dr Shankara Mahadev  Axon Hospital  Axon Hospital, 8-3-215, S. R. Nagar, Ameerpet, Hyderabad – 500 038
Hyderabad
ANDHRA PRADESH 		 9848050717

drdoddala@gmail.com 
Dr Jaiprakash Baraskar  Baraskar Hospital & Research Centre, Nagpur  Dr. Baraskar Hospital and Research Center, Room 05 3rd Floor 278 Central Bazaar Road Ramdaspeth, Nagpur 440010
Nagpur
MAHARASHTRA 		 9422108822

jpcancercare@yahoo.co.in 
Dr Tanveer Maksud  Bharat Cancer Hospital and Research Institute  Shree Bhartitamalya Medical Foundation, Manavdaya Trust Complex,Surat Bardoli Road, Saroli-395010
Surat
GUJARAT 		 9909918887

tanveermaksud@yahoo.com 
Dr Sujata Vasani  Bhatia Hospital Medical Research Society  Bhatia Hospital Medical Research Society, Tardeo Road, Grant Road (W), Mumbai 400007, India
Mumbai
MAHARASHTRA 		 9821188509

sujatavasani@hotmail.com 
Dr Chetan Deshmukh  Deenanath Mangeshkar Hospital, Pune  Erandwane, Pune - 411004
Pune
MAHARASHTRA 		 9850841449

drchetandeshmukh@gmail.com 
Dr Rajesh Kumar Grover  Delhi State Cancer Institute  Delhi State Cancer Institute, Dilshad Garden, Delhi-11009
East
DELHI 		 9810170405

dsci.delhi@yahoo.co.in 
Dr Ashok Diwan  Government Medical College  Radiation Department, Government Medical College, Medical Chowk, Nagpur-440009
Nagpur
MAHARASHTRA 		 9822816608

Tinuad_07@hotmail.com 
Dr Asha Anand  Gujarat Cancer & Research Institute, Ahmedabad  New Civil Hospital Campus, Asarwa, Ahmedabad-380016
Ahmadabad
GUJARAT 		 07922688419

gcri.clinicaltrials@gmail.com 
Dr Shekar Gowda Patil Medical Oncologist  HCG Banglore Institute of Oncology  HCG Bangalore Institute of Oncology HCG Towers Tower 1 3rd Floor Department of Medical Oncology HCG tower No 08 P Kalinga Rao Road Sampangiram Nagar Banglore 560 027
Bangalore
KARNATAKA 		 09341245961

sp_associates6@rediffmail.com 
Dr Ashish Kaushal  HCG Cancer Centre  Sola - Science City Road, S. G. Highway, Ahmedabad 380 060
Ahmadabad
GUJARAT 		 09978297842

drashish4@yahoo.co.in 
Dr Niraj Bhatt  Kailash Cancer Hospital & Research Centre  Kailash Cancer Hospital & Research Centre Muni Seva Ashram, Goraj-391760,Ta: Waghodia Dist: Vadodara-Gujarat
Vadodara
GUJARAT 		 9925581480

nirajbhatt1974@gmail.com 
Dr Krishna Prasad  Kasturba Medical College Hospital  Department of Medical Oncology Attavar Mangalore 575 001
Dakshina Kannada
KARNATAKA 		 91-0824-445858

drkrishnaprasad@hotmail.com 
Dr Minish Jain  KEM Hospital, Pune  K. E. M. Hospital, Day Care Centre, 3rd Floor, Banoo Cooyaji Building, Sardar Moodliar Road, Rasta Peth Pune-411011
Pune
MAHARASHTRA 		 9823133390

drminishjain@yahoo.co.in 
Dr Unmesh Talkalkar Onco Surgeon  Kodlikeri Memorial Hospital  8 Manjeet Nagar Opp Akashwani Jalna Road 431 005
Aurangabad
MAHARASHTRA 		 9822042425

unmesh_3@sancharnet.in 
Dr Ganapathi Raman  Kumaran Hospital  Kumaran Hospital,214 Eviar Periyar salai, Poonamalle High Road, Kilpauk, Chennai-600010
Chennai
TAMIL NADU 		 9840410194

sgraman8@gmail.com 
Dr Murali Krishna Voonna  Mahatma Gandhih Cancer Hospital & Research Institute, Vishakhapatnam  A unit of Vizag Hospital and Cancer Research Centre Pvt Ltd 1/7 MVP colony, Vishakhapatnam 530046
Visakhapatnam
ANDHRA PRADESH 		 9848191287

muralivoonna@yahoo.com 
Dr Kirushna Kumar  Meenakshi mission hospital  Meenakshi Mission hospital and research Centre Lake Area Melur Road 625 107
Madurai
TAMIL NADU 		 09787713004

drkskk@yahoo.com 
Dr Sandeep Jasuja  R. K. Birla Cancer Centre, Jaipur  R. K. Birla Cancer Centre Department of Medical Oncology, SMS Medical College Jawaharlal Nehru Marg, Jaipur -302004
Jaipur
RAJASTHAN 		 9888574226

sandeepjasuja@gmail.com 
Dr Surendra Beniwal  S. P. Medical College, Bikaner  Acharya Tulsi Regional Cancer Institute & Research Centre, S P Medical College & A G of Hospitals Bikaner-334003
Bikaner
RAJASTHAN 		 9414370484

beniwal.surendra@gmail.com 
Dr Tushar Patil  Sahyadri Speciality Hospital  no 30 C Karve Road Erandawane Deccan Gymkhana 411 004
Pune
MAHARASHTRA 		 9822404983

shahikant.apte@gmail.com 
Dr Anita Ramesh Professor of Medical Oncology  SRI RAMACHANDRA MEDICAL CENTRE  Department of General Medicine SRI Ramachandra University Porur Chennai 600 116 Tamil Nadu
Chennai
TAMIL NADU 		 09840758567

anitachandra100@hotmail.com 
Dr Cecil Ross Professor and HOD of Medical Oncology  St Johns Medical College & Hospital  Sarjapur Road Near Madiwala check post 560 034
Bangalore
KARNATAKA 		 09448493705

cecilross@bsnl.in 
Dr Dileep Srinivasan Consultant Medical Oncologist  Sterling Hospital  Sterling Hospital Road Memnagar 380 052
Ahmadabad
GUJARAT 		 9825326343

sdileeponc@hotmail.com 
Dr Rajendersingh Arora  Sujan Surgical Cancer Hospital And Amravati Cancer Foundation  Sujan Surgical Cancer Hospital And Amravati Cancer Foundation 52/B , Shankar Nagar , Main Road Amravati,444606.Maharastra ,India
Amravati
MAHARASHTRA 		 9823097573

dr_rsarora@rediffmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 20  
Name of Committee  Approval Status 
Action Cancer Hospital Ethics Committee  Approved 
Delhi State Cancer Institute Independent Ethics Committee  Approved 
Ethics Committee - S. P. Medical College and A. G. of Hospitals  Approved 
Ethics Committee Kodlikeri Memorial Hospital & CIIGMA Hospital  Approved 
Ethics Committee Meenakshi Mission Hospital & Research Centre  Approved 
Ethics Committee of the SMS Medical college, Jaipur  Approved 
GCRI/GCS Ethics Committee  Approved 
HCG Multi Speciality Ethics Committee  Approved 
HCG-Central Ethics Committee  Approved 
Institutional Ethics Committee - Deenanath Mangeshkar Hospital  Approved 
Institutional Ethics Committee of Sri Ramachandra University  Submittted/Under Review 
Institutional review Board-Asirvatham Speciality Hospital  Submittted/Under Review 
KEM Hospital Research Centre Ethics Committee  Approved 
Mahatma Gandhi Cancer Hospital & Research Institute Institutional Review Board  Approved 
Manipal University Ethics Committee  Approved 
Nagpur Independent Ethics Committee  Approved 
Sahayadri Hospitals Ltd Ethics Committee  Submittted/Under Review 
Shri Bhartimaiya Memorial Foundation Ethics Committee  Submittted/Under Review 
St. Johns Medical College & Hospital Institutional Ethics Committee  Approved 
Sterling Hospital Ethics Commmittee  Submittted/Under Review 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied
Modification(s)  
Health Type  Condition 
Patients  Patients with Non-Hodgkin’s Lymphoma,  
 
Intervention / Comparator Agent
Modification(s)  
Type  Name  Details 
Comparator Agent  Mabthera® (Ristova®)  Dose: 375 mg/m2 intravenous infusions on day 1 of each cycle (21 days) in combination with chemotherapy (CHOP) during induction phase; Duration: up to 2 years; Frequency: Six cycles; Mode of Administration: Intravenous 
Intervention  Rituximab code named R-TPR-017  Dose: 375 mg/m2 intravenous infusions on day 1 of each cycle (21 days) in combination with chemotherapy (CHOP) during induction phase; Duration: up to 2 years; Frequency: Six cycles; Mode of Administration: Intravenous 
 
Inclusion Criteria
Modification(s)  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. Previously untreated patients
2. Histologically confirmed, newly diagnosed follicular B cell Non-Hodgkins lymphoma or diffuse large B cell Non-Hodgkins lymphoma
3. CD20 positive by immunohistochemistry
4. Patients with at least one target lesion (lymph node with short axis of less than or equal to 15 mm by CT scan with contrast)
5. ECOG performance status 0 to 2
6. Life expectancy more than six months
7. Able to comprehend and give informed consent for the study and willing to come for follow up visit as per protocol requirements
8. Consent from Legally Acceptable Representative (LAR), if subject is not in a condition to give consent. However, when the subject is stable and is able to give consent, the consent would be obtained on a separate ICF to confirm his/her willingness to continue participation in the study. 
 
ExclusionCriteria 
Details  1. Presence or history of CNS disease (either CNS lymphoma or lymphomatous meningitis)
2. Patients with prior or concomitant malignancy
3. Patients with abnormal laboratory parameters like:
• Serum creatinine 2.0 times of upper normal limit
• AST or ALT 2.5 times of upper normal limit
• Alkaline phosphatase ≥1.5 times of upper normal limit
• Platelet count 100,000/ZL.
• Hemoglobin 8.0 g/dL.
• Absolute Neutrophil Count (ANC) 1.5 x 109 /L.
• Serum Immunoglobulin G (IgG) level 3.0 g/L
4. History of prior chemotherapy, stem cell transplant and radiotherapy
5. History of high dose, systemic, steroid therapy within 6 weeks
6. Previous use of non-human monoclonal antibody therapy and or known hypersensitive to murine proteins
7. Serious underlying medical condition which could impair the ability of patient to participate in the trial (e.g. Active systemic infection)
8. Severe cardiovascular disease within 12 months including myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident or transient ischemic attack, pulmonary embolism, life threatening arrhythmias or uncontrollable hypertension
9. Pregnant or lactating females or women of child-bearing potential, unwilling or unable to use proper contraceptive precautions during the study
10. Subjects with HIV, HBsAg, HCV test positive
11. Subject participation in another clinical trial 30 days prior to administration of IP
12. Any other condition which the Investigator feels would pose a significant hazard to subject if IP is administered 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Centralized 
Blinding/Masking   Open Label 
Primary Outcome
Modification(s)  
Outcome  TimePoints 
Efficacy will be assessed as Objective Response Rate (Complete Response and Partial Response) assessed by RECIST 1.1 criteria  at 24 weeks 
 
Secondary Outcome
Modification(s)  
Outcome  TimePoints 
Proportion of patients with Objective Response Rate {Complete Response and Partial Response} assessed by RECIST 1.1 criteria  At 10 weeks, 24 weeks, 1year, 1.5 year and 2 year 
 
Target Sample Size   Total Sample Size="105"
Sample Size from India="105" 
Final Enrollment numbers achieved (Total)= "106"
Final Enrollment numbers achieved (India)="106" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)
Modification(s)  		 21/04/2012 
Date of Study Completion (India) 12/02/2019 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="5"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   Not applicable 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary
Modification(s)  

This was a prospective, multi-centric, open label, two arm, parallel group, active control, randomized, comparative clinical study to evaluate the efficacy and safety of R-TPR-017/ Mabthera® (Ristova®) in patients with Non Hodgkin’s Lymphoma. The analysis of primary efficacy end point i.e. ORR at week 24 shows comparable response for both R-TPR-017 and MabThera® (Ristova®) arm (87.87% Vs. 86.86%). The proportions of subjects showing ORR in each arm were compared for statistical significance and the difference was found to be non-significant.The safety and efficacy of the R-TPR-017 was comparable to Mabthera® (Ristova®) in  terms of ORR, progression free survival and overall survival.  The adverse events for both treatment groups were consistent with the known safety profile of R-CHOP. No new safety concerns were identified with respect AE in either arm in this study.  Thus R-TPR-017 was found to be comparable in terms of safety and efficacy in patients with newly diagnosed diffuse large-B-cell lymphoma or follicular lymphoma.


 
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