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1 Clinical Trial Details (PDF Generation Date :- Fri, 11 Jan :36:45 GMT) CTRI Number Last Modified On 30/03/2018 Post Graduate Thesis Type of Trial Type of Study Study Design Public Title of Study Scientific Title of Study CTRI/2011/12/ [Registered on: 14/12/2011] - Trial Registered Prospectively Interventional Biological Randized, Parallel Group, Active Controlled Trial To study the effects of two drugs, R-TPR-017 and Mabthera (Ristova ) in cancer patients (n-hodgkin s Lympha) Prospective, multi-centric, open-label, two-arm, parallel group, active-control, randized, cparative clinical study to evaluate efficacy and safety of R-TPR-017 / MabThera (Ristova ) in patients with n-hodgkins Lympha Secondary IDs if Any Secondary ID Identifier Details of Principal Investigator or overall Trial Coordinator (multi-center study) Details Contact Person (Scientific Query) Details Contact Person (Public Query) RLS/TP/2010/07, version 6.0, dt. 8 Jan 2013 Designation Affiliation Protocol Number Details of Principal Investigator Dr Prashant A Pandya Phone Fax Designation Affiliation General Manager Clinical Research Services Reliance Life Sciences Pvt Ltd Reliance Life Sciences Pvt Ltd Dhirubhai Ambani Life Sciences Centre R 282 TTC Area of MIDC Rabale Navi Mumbai Thane India prashant.pandya@relbio.c Details Contact Person (Scientific Query) Dr Devi Manjula Medical Monitor Phone Fax Designation Affiliation Reliance Life Sciences Pvt Ltd Reliance Life Sciences Pvt. Ltd , 1st Phase, 2nd Stage, BTM Layout, Bangalore Bangalore KARNATAKA India devi.manjula@relbio.c Details Contact Person (Public Query) Dr Parvez Kosgi Head - RLS Trials Reliance Life Sciences Pvt Ltd Reliance Life Sciences Pvt.Ltd Dhirubhai Ambani Life Sciences Centre R 282 TTC Area of MIDC Rabale Navi Mumbai Thane India page 1 / 8

2 Source of Monetary or Material Support Primary Sponsor Details of Secondary Sponsor Countries of Recruitment Sites of Study Phone Fax 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 India Type of Sponsor NIL List of Countries India of Principal Investigator Dr J B Sharma Dr Joseph Jebasingh Primary Sponsor Details Reliance Life sciences Pvt Ltd Dhirubhai Ambani Life Sciences Centre Plot R 282 TTC Area of MIDC Thane Belapur Road Rabale Navi Mumbai India Pharmaceutical industry-indian NIL of Site Site Phone/Fax/ Action Cancer Hospital, New Delhi Asirvatham Speciality Hospital, Madurai Action Cancer Hospital, A-4, Paschim Vihar, Ro 806, Clinical Research Dept, New Delhi-63 New Delhi DELHI dr_sharmajb@rediffmail.c 22 Rajaji Street, Gandhinagar, Madurai jjebasingh@gmail.c Madurai TAMIL NADU Dr Shankara Mahadev Axon Hospital Axon Hospital, , S. R. Nagar, Ameerpet, Hyderabad Hyderabad ANDHRA PRADESH Dr Jaiprakash Baraskar Baraskar Hospital & Research Centre, Nagpur Dr Tanveer Maksud Dr Sujata Vasani Bharat Cancer Hospital and Research Institute Bhatia Hospital Medical Research Society Dr. Baraskar Hospital and Research Center, Ro 05 3rd Floor 278 Central Bazaar Road Ramdaspeth, Nagpur Nagpur Shree Bhartitamalya Medical Foundation, Manavdaya Trust Cplex,Surat Bardoli Road, Saroli Surat Bhatia Hospital Medical Research Society, Tardeo Road, Grant Road (W), Mumbai , India drdoddala@gmail.c jpcancercare@yahoo.c o.in tanveermaksud@yahoo.c sujatavasani@hotmail.c page 2 / 8

3 Dr Chetan Deshmukh Dr Rajesh Kumar Grover Dr Ashok Diwan Dr Asha Anand Dr Shekar Gowda Patil Medical Oncologist Deenanath Mangeshkar Hospital, Pune Delhi State Cancer Institute Government Medical College Gujarat Cancer & Research Institute, Ahmedabad HCG Banglore Institute of Oncology Mumbai Erandwane, Pune Pune Delhi State Cancer Institute, Dilshad Garden, Delhi East DELHI Radiation Department, Government Medical College, Medical Chowk, Nagpur Nagpur New Civil Hospital Campus, Asarwa, Ahmedabad Ahmadabad Dr Ashish Kaushal HCG Cancer Centre Sola - Science City Road, S. G. Highway, Ahmedabad Ahmadabad Dr Niraj Bhatt Dr Krishna Prasad Kailash Cancer Hospital & Research Centre Kasturba Medical College Hospital drchetandeshmukh@g mail.c dsci.delhi@yahoo.co.in Tinuad_07@hotmail.co m gcri.clinicaltrials@gmail. c HCG Bangalore Institute of Oncology HCG Towers Tower 1 sp_associates6@rediff 3rd Floor Department of mail.c Medical Oncology HCG tower 08 P Kalinga Rao Road Sampangiram Nagar Banglore Bangalore KARNATAKA Kailash Cancer Hospital & Research Centre Muni Seva Ashram, Goraj ,Ta: Waghodia Dist: Vadodara-Gujarat Vadodara Department of Medical Oncology Attavar Mangalore Dakshina Kannada KARNATAKA drashish4@yahoo.co.in nirajbhatt1974@gmail.c drkrishnaprasad@hotm ail.c Dr Minish Jain KEM Hospital, Pune K. E. M. Hospital, Day Care Centre, 3rd Floor, Banoo Cooyaji Building, drminishjain@yahoo.co. Sardar Moodliar Road, in Rasta Peth Pune Pune page 3 / 8

4 Dr Unmesh Talkalkar Onco Surgeon Kodlikeri Memorial Hospital 8 Manjeet Nagar Opp Akashwani Jalna Road Aurangabad unmesh_3@sancharnet.in Dr Ganapathi Raman Kumaran Hospital Kumaran Hospital, Eviar Periyar salai, Poonamalle High Road, sgraman8@gmail.c Kilpauk, Chennai Chennai TAMIL NADU Dr Murali Krishna Voonna Dr Kirushna Kumar Dr Sandeep Jasuja Dr Surendra Beniwal Dr Tushar Patil Dr Anita Ramesh Professor of Medical Oncology Dr Cecil Ross Professor and HOD of Medical Oncology Mahatma Gandhih Cancer Hospital & Research Institute, Vishakhapatnam Meenakshi mission hospital R. K. Birla Cancer Centre, Jaipur S. P. Medical College, Bikaner Sahyadri Speciality Hospital SRI RAMACHANDRA MEDICAL CENTRE St Johns Medical College & Hospital A unit of Vizag Hospital and Cancer Research Centre Pvt Ltd 1/7 MVP colony, Vishakhapatnam Visakhapatnam ANDHRA PRADESH muralivoonna@yahoo.c Meenakshi Mission hospital and research Centre Lake Area Melur drkskk@yahoo.c Road Madurai TAMIL NADU R. K. Birla Cancer Centre Department of Medical Oncology, SMS sandeepjasuja@gmail.c Medical College Jawaharlal Nehru Marg, Jaipur Jaipur RAJASTHAN Acharya Tulsi Regional Cancer Institute & Research Centre, S P Medical College & A G of Hospitals Bikaner Bikaner RAJASTHAN no 30 C Karve Road Erandawane Deccan Gymkhana Pune Department of General Medicine SRI Ramachandra University Porur Chennai Tamil Nadu Chennai TAMIL NADU Sarjapur Road Near Madiwala check post Bangalore beniwal.surendra@gma il.c shahikant.apte@gmail.c anitachandra100@hotm ail.c cecilross@bsnl.in page 4 / 8

5 Details of Ethics Dr Dileep Srinivasan Consultant Medical Oncologist Sterling Hospital Dr Rajendersingh Arora Sujan Surgical Cancer Hospital And Amravati Cancer Foundation KARNATAKA Sterling Hospital Road Memnagar Ahmadabad Sujan Surgical Cancer Hospital And Amravati Cancer Foundation 52/B, Shankar Nagar, Main Road Amravati, Maharastra,India Amravati m of Approval Status Date of Approval Is Independent Ethics? Action Cancer Hospital Delhi State Cancer Institute Independent - S. P. Medical College and A. G. of Hospitals Kodlikeri Memorial Hospital & CIIGMA Hospital Meenakshi Mission Hospital & Research Centre of the SMS Medical college, Jaipur GCRI/GCS Ethics HCG Multi Speciality HCG-Central Ethics Approved 27/05/2013 Approved 06/12/2013 Approved 10/07/2013 Approved 29/07/2013 Approved 22/07/2013 Approved 10/07/2013 Approved 28/10/2013 Approved 13/01/2014 Approved 01/08/2013 Institutional Ethics Approved 10/10/ Deenanath Mangeshkar Hospital Institutional Ethics of Sri Ramachandra University Institutional review Board-Asirvatham Speciality Hospital KEM Hospital Research Centre Ethics Mahatma Gandhi Cancer Hospital & Research Institute Approved 14/08/2013 Approved 18/05/2013 page 5 / 8

6 Regulatory Clearance Status fr DCGI Health Condition / Problems Studied Intervention / Cparator Agent Inclusion Criteria Institutional Board Manipal University Nagpur Independent Sahayadri Hospitals Ltd Shri Bhartimaiya Memorial Foundation St. Johns Medical College & Hospital Institutional Ethics Sterling Hospital Ethics Cmmittee Status Approved 13/06/2013 Approved 07/05/2013 Yes Approved 22/07/2013 Date Approved/Obtained 07/06/2011 Health Type Patients Condition Patients with n-hodgkin s Lympha Type Details Intervention Rituximab code named R-TPR-017 Dose: 375 mg/m2 intravenous infusions on day 1 of each cycle (21 days) in cbination with chemotherapy (CHOP) during induction phase; Duration: up to 2 years; Frequency: Six cycles; Mode of Administration: Intravenous Cparator Agent Mabthera (Ristova ) Dose: 375 mg/m2 intravenous infusions on day 1 of each cycle (21 days) in cbination with chemotherapy (CHOP) during induction phase; Duration: up to 2 years; Frequency: Six cycles; Mode of Administration: Intravenous Age Fr Age To Gender Details Year(s) Year(s) Both Inclusion Criteria 1. Previously untreated patients 2. Histologically confirmed, newly diagnosed follicular B cell n-hodgkins lympha or diffuse large B cell n-hodgkins lympha 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 cprehend and give informed consent for the study and willing to ce for follow up visit as per protocol requirements 8. Consent fr Legally Acceptable Representative (LAR), if subject is not in a condition to give consent. However, when the subject is page 6 / 8

7 Exclusion Criteria Method of Generating Rand Sequence Method of Concealment Blinding/Masking Details Cputer generated randization Centralized Open Label 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. Exclusion Criteria 1. Presence or history of CNS disease (either CNS lympha or lymphatous meningitis) 2. Patients with prior or concitant 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, symptatic congestive heart failure, cerebrovascular accident or transient ischemic attack, pulmonary embolism, life threatening arrhythmias or uncontrollable hypertension 9. Pregnant or lactating females or wen 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 Primary Outce Outce Timepoints Efficacy will be assessed as Objective Response Rate (Cplete Response and Partial Response) assessed by RECIST 1.1 criteria at 24 weeks Secondary Outce Outce Timepoints Target Sample Size Phase of Trial Phase 3 Date of First Enrollment (India) Date of First Enrollment (Global) Estimated Duration of Proportion of patients with Objective Response Rate {Cplete Response and Partial Response} assessed by RECIST 1.1 criteria Total Sample Size=105 Sample Size fr India=105 21/04/2012 Years=5 At 10 weeks, 24 weeks, 1year, 1.5 year and 2 year page 7 / 8

8 Powered by TCPDF ( PDF of Trial Trial Recruitment Status of Trial (Global) Recruitment Status of Trial (India) Publication Details Brief Summary Months=0 Days=0 t Applicable Closed to Recruitment of Participants t applicable This is a prospective, multi-centric, open label, two arm, parallel group, active control, randized, cparative clinical study to evaluate the efficacy and safety of R-TPR-017/ Mabthera (Ristova ) in patients with n Hodgkin s Lympha page 8 / 8