PDF of Trial CTRI Website URL - http://ctri.nic.in Clinical Trial Details (PDF Generation Date :- Wed, 29 Sep 2021 08:30:34 GMT) CTRI Number CTRI/2011/07/001868 [Registered on: 07/07/2011] - Trial Registered Prospectively Last Modified On 18/11/2019 Post Graduate Thesis No Type of Trial Interventional Type of Study Biological Study Design Non-randomized, Multiple Arm Trial Public Title of Study A clinical trial on an anticancer agent in patients with Non Hodgkins Lymphoma Scientific Title of A Phase I/II First in Human, Open Label, Multi-centre, Dose Escalation, Dose Finding, Safety and Study Tolerability Study of BVX20 administered intravenously in patients with Relapsed/Refractory CD20+ B cell Non Hodgkins Lymphoma Secondary IDs if Any Secondary ID Identifier BVX20-CT1-001-10 Protocol Number Details of Principal Details of Principal Investigator Investigator or overall Name Dr Chandrashekar Bolmall Trial Coordinator (multi-center study) Designation Senior Scientific Manager Affiliation Biocon Research Limited Address Biocon Research Limited – SEZ Unit, Plot No: 2 & 3, Phase IV-BIA, Bommasandra-Jigani Link Road, Bangalore, India Bangalore KARNATAKA 560 099 India Phone 8028085305 Fax 8028085323 Email [email protected] Details Contact Details Contact Person (Scientific Query) Person (Scientific Name Dr Chandrashekar Bolmall Query) Designation Senior Scientific Manager Affiliation Biocon Research Limited Address Biocon Research Limited – SEZ Unit, Plot No: 2 & 3, Phase IV-BIA, Bommasandra-Jigani Link Bangalore KARNATAKA 560 099 India Phone 8028085305 Fax 8028085323 Email [email protected] Details Contact Details Contact Person (Public Query) Person (Public Query) Name Ms Jayanti Panda Designation Principal Scientist Affiliation Biocon Research Limited Address Biocon Research Limited – SEZ Unit, Plot No: 2 & 3, Phase IV-BIA, Bommasandra-Jigani Link Road, Bangalore, India Bangalore KARNATAKA 560 099 India page 1 / 6 PDF of Trial CTRI Website URL - http://ctri.nic.in Phone 8028085346 Fax 8028085323 Email [email protected] Source of Monetary or Source of Monetary or Material Support Material Support > Biocon Limited Primary Sponsor Primary Sponsor Details Name Biocon Limited Address Biocon Ltd, 20th KM Hosur Road, Electronic City, Bangalore 560100, Karnataka Type of Sponsor Pharmaceutical industry-Indian Details of Secondary Name Address Sponsor NIL NIL Countries of List of Countries Recruitment India Sites of Study Name of Principal Name of Site Site Address Phone/Fax/Email Investigator Dr Atul Sharma AIIMS Department of Medical 9818548149 Oncology, Institute Rotary Cancer Hospital, [email protected] All India Institute of Medical Sciences, Ansari Nagar West, New Delhi, Delhi 110029 New Delhi DELHI Dr SVSS Prasad Apollo Hospitals Apollo Hospitals, 9848018804 Jubilee Hills, Hyderabad – 500 096 [email protected] AP, India. om Hyderabad ANDHRA PRADESH Dr Tanveer Maksud Bharat Cancer Hospital Bharat Cancer Hospital 9909918887 and Research Institute and Research Institute, Manav Daya trust tanveermaksud@yahoo complex, Surat Bardol .com Road, Saroli- 395010, Gujrat, India Surat GUJARAT Dr Ajay Mehta Central India Cancer Central India Cancer 9823190192 Research Institute Research Institute, 11, Shankar Nagar, West [email protected] High Court Road,Nagpur – 440010. Maharashtra, India Nagpur MAHARASHTRA Dr Rajnish Vasant Curie Manavta Cancer Curie Manavta Cancer 9823061929 Nagarkar Centre Centre Opp Mahamarg Bus Stand, Mumbai drraj@manavatacancer Naka Nasik– 422004 centre.com Maharashtra, India Nashik MAHARASHTRA page 2 / 6 PDF of Trial CTRI Website URL - http://ctri.nic.in Dr Chetan Deshmukh Deenanath Mangeshkar Deenanath Mangeshkar 9850811449 Hospital Hospital, Near Mathre Bridge, Erandawane, drchetandesmukh@gm Pune-411004 ail.com Pune MAHARASHTRA DrShekhar Gowda Patil HCG Bangalore HCG Bangalore 9341245961 Institute of Oncology Institute of Oncology, C/O Triesta Sciences A [email protected] Unit of Healthcare om Global Enterprises, #8, P.Kalinga Rao Road, Sampangi Rama Nagar, Bangalore-560027 Bangalore KARNATAKA Dr Sharat Damodhar Mazumdar Shaw Consultant 91-80-27835000 Cancer Centre Hematologist and Bone Marrow Transplant drsharat_damodar@ya Physician, Mazumdar hoo.co.in Shaw Cancer Centre, Narayana Hrudayalaya, No 258/A, Bommasandra Industrial Area Anekal Taluk, Bommasandra, Bengaluru, Karnataka 560099 Bangalore KARNATAKA Dr AK Vaid Medanta Cancer Medanta Cancer 9810212235 Institute Institute, Medanta The Medicity, Sector [email protected] 38,Gurgaon – rg 122001,Haryana, India. Gurgaon HARYANA Dr Hari Menon Tata Memorial Hospital Tata Memorial Hospital 9819913164 Dr. E. Borges Marg Parel, Mumbai– 400 [email protected] 012 Maharashtra, India o.in Mumbai MAHARASHTRA Details of Ethics Name of Committee Approval Status Date of Approval Is Independent Ethics Committee Committee? Central Ethics Approved 24/12/2012 No Committee HCG Tower1, 1 floor Board Room, 8. P Kalinga Rao Road Sampangiram Nagar Bangalore-560027 Central India Cancer Approved 13/10/2012 No Research Institute Ethics Committee, 11,Shankar Nagar, Nagpur 440010 INDIA Ethics committee, Approved 14/09/2012 No page 3 / 6 PDF of Trial CTRI Website URL - http://ctri.nic.in Apollo Hospital, Jubilee Hill, Hydrabad 500096 Institutional Ethics Approved 05/09/2012 No committee, AIIMS, Ansari Nagar West, New Delhi, Delhi 110029 Manavata clinical Approved 02/11/2012 No Research Institute Professional Ethics Committee Medanta Approved 06/04/2011 No Narayana Hrudayalaya Approved 10/11/2010 No Medical Ethics Committee, Narayana Hrudayalaya Hospital, no. 258/A, Bommasandra indrustrial Area, Aneka (Taluk), Bangalore - 560 099 Tata Memorial Centre Approved 16/11/2012 No Mumbai Regulatory Clearance Status Date Status from DCGI Approved/Obtained 31/05/2011 Health Condition / Health Type Condition Problems Studied Patients Non Hodgkins Lymphoma Intervention / Type Name Details Comparator Agent Intervention BVX20 Cohort 1 - 3 patients will be enrolled into 100 mg/dose - once weekly infusions for 4 weeks Comparator Agent Not Applicable None Intervention BVX20 Cohot 2 to 5 - 10 patients will be enrolled into each of the dose cohorts of 300 mg/dose, 500 mg/dose, 700 mg/dose,1000 mg/dose sequentially - once weekly infusions for 4 weeks Inclusion Criteria Inclusion Criteria Age From 18.00 Year(s) Age To 70.00 Year(s) Gender Both Details Patients with histologically confirmed relapsed/refractory mature B cell CD20+ lymphoma [either follicular lymphoma (FL), WHO grade I, II, IIIa or aggressive lymphoma (FL WHO grade IIIb, Bulky disease, or Diffuse Large B cell lymphoma (DLBCL))] <br/> Bi-dimensionally measurable disease documented at or within 28 days of enrolment, as defined by two or more clearly demarcated lesions on CT with largest diameter ≥1.5 cm OR a single lesion with largest diameter ≥2.0 cm.<br/> Must be willing to undergo upto 2 bone marrow aspirations during the trial<br/> Less than 5000 circulating lymphoid cells per μl on a WBC differential count<br/> <br/> Relapse/Refractory Patients - definition: - Patients should have progressed after completion of the previous NHL page 4 / 6 PDF of Trial CTRI Website URL - http://ctri.nic.in treatment which had induced CR, CRu or PR for at least 3 months (6 months for rituximab-based therapy), or be refractory to any NHL treatment for at least 6 months. Patients who have relapsed following anti-CD20 therapy must not have relapsed or progressed within 6 months of starting therapy or while receiving anti-CD20 therapy<br/> Exclusion Criteria Exclusion Criteria Details Other types of CD20+ lymphoma, other than those mentioned in inclusion criteria Evidence of central nervous system involvement by lymphoma Previous radio-immunotherapy or stem cell transplantation Received mitomycin or nitrosureas within 6 weeks prior to enrolment Received anti-cancer therapy, glucocorticosteriods (10 mg/day) or radiation within 4 weeks prior to enrolment Received rituximab within 6 months before inclusion or has received more than 2 cycles of treatment with rituximab previously regardless of response Previous treatment with rituximab resulting in less than partial response or duration of response less than 6 months Documented intolerance or contraindication to glucocorticosteriod use HIV or Hepatitis B or C positivity More than 10 x 109/L circulating CD20+ lymphoma cells, platelets 75000/?L, neutrophils 1500 /?L, serum creatinine 1.5 times upper normal limit (unless normal creatinine clearance), total bilirubin 1.5 times upper normal limit (unless due to liver involvement of lymphoma), alanine amino transferase or alkaline phosphatase 2.5 times upper normal limit (unless due to liver involvement of lymphoma) WHO performance status 3 or 4 (Appendix 33.3) Clinical suspicion of active or latent tuberculosis infection or positive Mantoux test for tuberculosis (20 mm induration or ?20 mm ulcerative or bullous lesion on 5 TU Mantoux test) Method of Generating Not Applicable Random Sequence Method of Not Applicable Concealment Blinding/Masking Open Label Primary Outcome Outcome Timepoints Safety and tolerability of BVX20 monotherapy 4 weeks and identification of the MTD for BVX20 Secondary Outcome Outcome Timepoints Efficacy of BVX20, Immunogenicity, 2 months, 6 months and 2 years Pharmacokinetics of BVX20 Target Sample Size Total Sample Size=50 Sample Size from India=50 Final Enrollment numbers achieved (Total)=Applicable only for Completed/Terminated trials Final Enrollment numbers achieved (India)=Applicable