REF/2015/03/ CTRI Website URL -

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1 Clinical Trial Details (PDF Generation Date :- Wed, 02 May :39:07 GMT) CTRI Number Last Modified On 30/01/2017 Post Graduate Thesis Type of Trial Type of Study Study Design Public Title of Study Scientific Title of Study CTRI/2015/05/ [Registered on: 26/05/2015] - Trial Registered Prospectively No Interventional Drug Biological Randomized, Parallel Group Trial A study comparing PF to MabThera (rituximab) in patients with follicular lymphoma who have not received previous treatment. A phase 3, randomized, double-blind study of PF versus Rituximab for the first-line treatment of patients with CD20-positive, low tumor burden, follicular lymphoma Secondary IDs if Any Secondary ID Identifier Details of Principal Investigator or overall Trial Coordinator (multi-center study) EudraCT B Protocol Amendment 1 dated 08 May 2014 NCT USIND- 110,426 Designation Affiliation Protocol Number ClinicalTrials.gov Other Details of Principal Investigator Details Contact Person (Scientific Query) Details Contact Person (Public Query) Phone Fax Designation Affiliation Details Contact Person (Scientific Query) Swapnali Raut Director Compliance Oversight Pfizer Limited Phone Fax Designation Affiliation Pfizer Centre, Patel Estate, SV Road, Jogeshwari West Mumbai India Swapnali.Raut@Pfizer.com Details Contact Person (Public Query) Swapnali Raut Director Compliance Oversight Pfizer Limited Pfizer Centre, Patel Estate, SV Road, Jogeshwari West Mumbai page 1 / 7

2 Source of Monetary or Material Support Primary Sponsor Details of Secondary Sponsor Countries of Recruitment Sites of Study India Phone Fax Source of Monetary or Material Support > Pfizer Inc, 235 East 42nd Street, New York, NY 10017, United States of America Type of Sponsor NIL List of Countries Austria Belarus Belgium Brazil Canada Croatia Egypt France Germany Greece India Italy Japan Lebanon Mexico Other Peru Philippines Poland Portugal Republic of Korea Romania Russian Federation South Africa Spain Switzerland Thailand Turkey Ukraine United Kingdom United States of America of Principal Investigator Primary Sponsor Details Pfizer Limited The Capital, 1802/1901, Plot No. C-70, G Block, Bandra Kurla Complex, Bandra (East), Mumbai , Maharashtra, India Pharmaceutical industry-indian NIL of Site Site Phone/Fax/ page 2 / 7

3 Dr Srinivas Chakravarthy Gummaraju Dr Raja Madras Ananthanarayanan Dr Manikandan Dhanushkodi Dr Biju George Dr Abhishek Satyawan Jadhav Apollo Hospitals (Apollo Cancer Institute) Apollo Speciality Hospital Cancer Institute (W.I.A) Regional Cancer Center Christian Medical College Curie Manavata Cancer Centre Room No: 04, Ground floor, Department of oncology Jubilee Hills, Hyderabad , Telangana Hyderabad ANDHRA PRADESH Room Number 17 & 18, Department of Oncology, Padma Complex, 320, Anna Salai, Chennai Chennai TAMIL NADU Medical Oncology Clinical Research Unit, rd Floor, Bhagwan Mahaveer Vishranthi Graha building, Dr. S. Krishnamurthy Campus, N0-38, Sardar Patel Road, Adyar, Chennai Chennai TAMIL NADU Room # 3, Department of Haematology, IDA Scudder Road Vellore Vellore TAMIL NADU Curie Manavata Cancer Centre, Department-surgical oncology Ground floor, OPD No-2, Opp. Mahamarg Bus Stand, Mumbai Naka, Nashik , Nashik Dr Ravikumar Saxena Global Hospital Department of Oncology, Room # 11, Fifth Floor, /1 to 4, Lakdi-ka-pul, Hyderabad Hyderabad ANDHRA PRADESH Dr Vijay Kumar Mahobia Dr Satheesh C T Government Medical College & Hospital HealthCare Global Enterprises Limited 85, Dept. of Radiation Therapy & Oncology Medical College Road, Near Hanuman Nagar, Nagpur Nagpur HCG Towers, #8, P.Kalinga Rao Road Sampangi Ram Nagar biju@cmcvellore.ac.in drabhishek@mcrinasik. com ravikumar1960@hotmai l.com drvijay_mahobia@yaho o.com drsateeshct@gmail.co page 3 / 7

4 Dr Sameer Ramesh Melinkeri Dr Karthik S Udupa Jehangir Clinical Development Centre Pvt. Ltd. Kasturba Hospital and Medical College Bangalore Bangalore KARNATAKA Clinical Research Department, Jehangir Hospital Premises, 32, Sassoon Road, Pune Pune Shirdi Saibaba Cancer Hospital & Research Center, Post Box No. 7, Manipal University Manipal Udupi KARNATAKA Dr Ashish Dixit Manipal Hospital Clinical Research Department, 3rd floor, # 98, HAL Airport Road, Bangalore Bangalore KARNATAKA Dr Prantar Chakrabarti Dr Sandeep Kumar Jasuja Dr Narendra Agrawal Dr Tanveer Mohibbhai Maksud Dr Shravan Narsingrao Tungenwar N. R. S. Medical College & Hospital, R. K. Birla Cancer Centre, Sawai Man Singh Hospital Rajiv Gandhi Cancer Institute and Research Centre Unique Hospital Multispeciality & Research Institute United CIIGMA Institute of Medical Sciences Pvt. Ltd. Room # 01, Department of Hematology, 138, A.J.C. Bose Road, Kolkata , Kolkata WEST BENGAL Department of Medical Oncology & BMT, Gate No. 06, JLN Marg Jaipur RAJASTHAN m docmelinkeri@yahoo.co m udupa.k@gmail.com ashish.dixit@manipalho spitals.com prantar@gmail.com sandeepjasuja@gmail.c om Hemato-Oncology Unit, Room No 2261, Second Floor, New building, narendra_ag1@rediffm Sector-5, Rohini, New ail.com Delhi New Delhi DELHI Basement, OPD- 02, Clinical Research Department,Opp. Kiran Motor, Nr.Canal, Civil Hospital Char Rasta - Sosyo Circle Lane, Off Ring Road, Surat Surat GUJARAT Wing A, Sixth Floor, Research Department, Plot No. 6, 7, Survey No. 10, Shahanoorwadi Darga Road, Aurangabad Aurangabad tanveermaksud@gmail. com drshravan.uch@gmail.c om page 4 / 7

5 Details of Ethics Committee Regulatory Clearance Status from DCGI Health Condition / Problems Studied of Committee Approval Status Date of Approval Is Independent Ethics Committee? Cancer Institute (W.I.A) Committee Apollo Hospitals, Chennai Apollo Hospitals, Hyderabad Jehangir Clinical Development Centre Pvt. Ltd, Pune Kodlikeri Memorial Hospital & CIIGMA Hospital of Manipal Hospitals of SMS Medical College & Attached Hospitals, Unique Hospital Submittted/Under Review No Date Specified No Approved 11/02/2015 No Approved 14/11/2015 No Approved 22/07/2015 No Approved 29/12/2014 No Approved 10/09/2015 No Approved 03/10/2016 No Approved 01/11/2015 No -Silver Approved 02/09/2015 No HCG Central Ethics Committee Committee, Global Hospitals Committee, Government Medical College Committee, N.R.S. Medical College & Hospital, (IECNRSMH) Institutional Review Board, Rajiv Gandhi Cancer Institute And Research Centre Manavata Clinical Research Institute (MCRI EC) Manipal University (MUEC) Status Approved 06/12/2016 No Approved 18/02/2015 No Approved 10/02/2015 No Approved 12/05/2015 No Approved 18/06/2015 No Approved 28/11/2015 No Approved 18/08/2015 No Date Approved/Obtained 16/04/2015 Health Type Patients Condition CD20-positive, low tumor burden, Follicular page 5 / 7

6 Intervention / Comparator Agent Inclusion Criteria Exclusion Criteria Method of Generating Random Sequence Method of Concealment Blinding/Masking Lymphoma Type Details Intervention Comparator Agent Age From Age To Gender Details Details PF (Other : Rituximab-Pfizer) MabThera (Other : Rituximab (EU)) Year(s) Year(s) Both Computer generated randomization Centralized Inclusion Criteria During the study, patients will receive 4 weekly doses of PF or rituximab-eu administered via intravenous infusion using the escalating infusion rate described in the Health Authority approved product labels. Blinded PF will be administered at a dose of 375 mg/m2 at Visits 2, 3, 4, and 5 (Days 1, 8, 15, and 22). Blinded investigational product will be administered by IV infusion using the escalating infusion rate described in the Health Authority approved product labels. Blinded rituximab-eu will be administered at a dose of 375 mg/m2 at Visits 2, 3, 4, and 5 (Days 1, 8, 15, and 22). Confirmed diagnosis of low tumor burden, CD20-positive follicular lymphoma (containing no elements of diffuse large B-cell lymphoma) Ann Arbor Stage II, III, or IV Eastern Cooperative Oncology Group (ECOG) status of 0 to 1 At least 1 measureable disease lesion of at least 1.5 cm in longest diameter Exclusion Criteria Not a candidate for treatment with rituximab as a single-agent Evidence of transformation to a high grade or diffuse large B-cell lymphoma Central nervous system or meningeal involvement or cord compression by the lymphoma. T-cell lymphoma. Any prior treatment for lymphoma Any prior treatment with rituximab Active, uncontrolled infection Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded Primary Outcome Outcome Timepoints Objective Response Rate (ORR) according to the revised response criteria for malignant lymphoma (2007) Week 26 Secondary Outcome Outcome Timepoints Time to Treatment Failure (TTF) Week 52 page 6 / 7

7 Powered by TCPDF ( REF/2015/03/ Target Sample Size Phase of Trial Phase 3 Date of First Enrollment (India) Date of First Enrollment (Global) Estimated Duration of Trial Recruitment Status of Trial (Global) Recruitment Status of Trial (India) Publication Details Brief Summary Progression-Free Survival(PFS) Week 52 Complete Remission (CR) rate Week 26 Duration of response Week 52 Overall survival Week 52 Maximum observed plasma concentration (Cmax) Week 52 Minimum observed plasma concentration (Cmin) Week 52 CD19-positive B-cell counts Week 52 Incidence of anti-drug antibodies (ADA) and safety associated with immune response Total Sample Size=394 Sample Size from India=35 29/05/ /11/2014 Years=3 Months=1 Days=0 Open to Recruitment Open to Recruitment Week 52 This study will compare the safety and effectiveness of PF versus rituximab-eu in patients with CD20-positive, low tumor burden follicular lymphoma. The primary hypothesis to be tested in this study is that the effectiveness of PF , as measured by the Overall Response Rate, is similar to that of rituximab-eu. page 7 / 7