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1 Clinical Trial Details (PDF Generation Date :- Mon, 18 Mar :33:59 GMT) CTRI Number Last Modified On 24/04/2012 Post Graduate Thesis Type of Trial Type of Study Study Design Public Title of Study Scientific Title of Study CTRI/2011/05/ [Registered on: 30/05/2011] - Trial Registered Retrospectively Interventional Drug Biological Single Arm Trial AN INVESTIGATOR INITIATED OBSERVATIONAL STUDY TO EVALUATE THE RESPONSE RATE AND TOXICITY (SAFETY) OF THE COMBINATION OF BENDAMUSTINE AND RITUXIMAB (BR) IN FRESH ADULT CHRONIC LYMPHOCYTIC LEUKEMIA PATIENTS AN INVESTIGATOR INITIATED, MULTICENTER, OPEN-LABEL, NON-RANDOMIZED, PROSPECTIVE, OBSERVATIONAL CLINICAL STUDY TO EVALUATE THE RESPONSE RATE AND TOXICITY (SAFETY) OF THE COMBINATION OF BENDAMUSTINE AND RITUXIMAB (BR) IN CHEMO-NAIVE ADULT CHRONIC LYMPHOCYTIC LEUKEMIA PATIENTS IN INDIA 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) 2010DRL001 Name Designation Affiliation Address Protocol Number Details of Principal Investigator Dr M B Agarwal Phone Fax Name Designation Affiliation Address Hematologist, Hemato - Oncologist Hematology Centre, Ghamat Lodge, II Floor, 804 A, Dr. B R Ambedkar Road, Dadar TT, Mumbai India mbagarwal@hotmail.com Details Contact Person (Scientific Query) Dr M B Agarwal Phone Fax Name Designation Affiliation Address Haematologist & Haemato Oncologist Sponsor & Principal Coordinating Investigator Hematology Centre Ghamat Lodge II Floor 804 A Dr. B R Ambedkar Road Dadar TT Mumbai India mbagarwal@hotmail.com Details Contact Person (Public Query) Ms Naga Anand Chief Executive Officer Consortium Clinical Research Pvt. Ltd., 9/41, Sri Kalki Gardens,Sugunapuram, Kuniyamuthur (Po), Coimbatore Coimbatore page 1 / 10

2 Source of Monetary or Material Support Primary Sponsor Details of Secondary Sponsor Countries of Recruitment Sites of Study TAMIL NADU India Phone Fax Source of Monetary or Material Support > Dr. Reddys Laboratories, Survey. 47, Bachupally, Qutubullapur, RR Dist, Hyderabad Name Address Type of Sponsor Name NIL List of Countries India Name of Principal Investigator Dr Anand Pathak Dr Avinash Pophali Dr A K Tripathi Dr Joseph John Dr Chetan Deshmukh Primary Sponsor Details DrMBAgarwal Hematology Centre, Ghamat Lodge, II Floor, 804 A, Dr. B R Ambedkar Road, Dadar TT, Mumbai , Maharashtra, India. Other [Individual Investigator] Address Name of Site Site Address Phone/Fax/ Cancer Care Clinic and Central India Institute of Haematology & Oncology Chhatrapati Sahuji Maharaj Medical University Christian Medical College & Deenanath Mangeshkar and Research Centre Consultant Oncologist and Hematologist,5th floor Vasant Sheela tower,,lokmat Square Nagpur Hematologist and Medical Oncologist, Ground I Floor, 14/2, Park Corner, Balraj Marg,,Near Lokmat Square, Dhantoli, Nagpur Hemato Oncologist, Department of Medicine, Chowk Lucknow UTTAR PRADESH Haematologist, Haemat o-oncologist,clinical Heamatology, Heamato-Oncology & Bone Marrow Transplant Unit Ludhiana PUNJAB Medical Oncologist,Era ndawne Pune jueely1194@yahoo.co.i n pophali@sify.com tripathiak2010@hotmail.com mjosephjohn@gmail.co m drchetandeshmukh@re diffmail.com Dr Seema Bhatwadekar Global Baroda Hematologist and page 2 / 10

3 Dr Jina Bhattacharyya Guwahati Medical College & Hemato-Oncologist, Nr. Shreyas Vidhyalaya, Manjalpur, Vadodara Vadodara GUJARAT Associate Professor, Department of Clinical Hematology, Guwahati Medical College and hospital, Guwahati Kamrup ASSAM Dr Kiran Shah Haematology Clinic Haematologist-Oncologi st,135, Shankheshwar Complex,Majura Gate, Surat GUJARAT Dr M B Agarwal Hematology Centre Hematologisst, 168-B Ghamat Lodge, 2nd Floor, Above ING Vaishya Bank,804 A, Dr. B. Ambedkar Road, Dadar TT Mumbai Dr Prantar Chakraborthy Dr Pritesh Junagade Dr Sushil Mandhaniya Institute of Haematology and Transfusion Medicine (IHTM) Lotus Institute of Haematology and Oncology Mandhaniya Cancer and Research Institute Associate Professor Hematologist, Department Of Hematology, 3rd Floor, MCH Building,Medical College, 88, College Street Kolkata WEST BENGAL Hematologist, Hemato- Oncologist,Bhavik Nagar,,Opp. Kujumagraj Vidyavikas Circle Nashik Wing A-101, 1st Floor, Neeti Gourav Complex,,20, Central Bazar Road, Lokmat Square, Nagpur Dr Sharat Damodar Narayan Hrudayalaya Consultant Hematologist,. 258/A, Bommasandra Industrial Area,Anekal Taluk Bangalore KARNATAKA ssbkar16@gmail.com drjinabhattacharyya@y ahoo.co.in kcs_haem@yahoo.co.in mbagarwal@hotmail.co m prantar@gmail.com pritesh.junagade@gmai l.com drsushil.cancercare@y ahoo.in drsharat_damodar@ya hoo.co.in Dr Malay Ghosh NRS Medical College 138, Acharya Jagadish page 3 / 10

4 Dr Pankaj Malhotra Postgraduate Institute of Medical Education & Research Chandra Bose Road,,Entally, Kolkata WEST BENGAL DEPARTMENT OF INTERNAL MEDICINE, SECTOR-12, PGIMER, CHANDIGARH Chandigarh CHANDIGARH Dr Babita Hapani Pragathi Consultant Medical Oncologist & Hematologist,NR Jasani College, Vidyanagar Main road,rajkot Rajkot GUJARAT Dr Dinesh Bhurani Dr Shashikant Apte Dr Hemant Malhotra Rajiv Gandhi Cancer Institute & Research Centre Sahayadri Speciality Sawai Man Singh Senior Consultant, Room no. 2261, New Building, IInd floor,,rohini, Sector-V, New Delhi DELHI Hematologist,Plot. 30C, Lane 2,,Prabhat Road, Deccan Gymkhana Pune Medical Oncologist,R K Birla Cancer Centre, Sawai Ramsingh Road,,J.L.N. Marg, Jaipur RAJASTHAN Dr Shailesh Bondarde Shatabdi Consulting Medical Oncologist, Suyojit City Centre, Opp. Mahamarg Bus Stand,Mumbai Naka Nashik Dr Manzoor Ahmed Banday Dr Cecil Ross Dr Sandip Shah Sher-I-Kashmir Institute of Medical Sciences St. Johns Medical College Vedanta Institute of Medical Sciences Soura Srinagar JAMMU & KASHMIR Hematologist, Room. 07, Department of Medicine,Sarjapur Road Bangalore KARNATAKA Hematologist, Medical Oncologist, 1st Floor, malay-ghosh@hotmail. com malhotrapankaj@yahoo.com babitahapani@gmail.co m bhurani@gmail.com shashikant.apte@gmail. com drmalhotrahemant@gm ail.com shaileshbondarde@yah oo.com mutaibma@yahoo.com cecilross@sify.com page 4 / 10

5 Details of Ethics Committee Dr Vijay Ramanan Yashoda Heamatology Clinic Stadium-Commerce College Road,,Navrang pura Ahmadabad GUJARAT Hemato-Oncologist,104 4, Shukrawar Peth, Ashwini Commercial Complex,,Hirabaugh Chowk, Tilak Road Pune Name of Committee Approval Status Date of Approval Is Independent Ethics Committee? Ethics Committee of Global Baroda IndependentEthicsCom mitteebangalore Institutional review Board Postgraduate Institute of Medical Education & Research Board, Chhatrapati Sahuji Maharaj Medical University Institutional review Board, Christian Medical College & Board, Deenanath Mangeshkar and Research Centre Board, Institute of Haematology and Transfusion Medicine (IHTM) Institutional review Board, Narayana Hrudayalaya Board, NRS Medical College Board, Rajiv Gandhi Cancer Institute & Research Centre Institutional review Board, Shatabdi Board, Sher-I-Kashmir Institute of Medical Sciences Approved 20/05/2011 Approved 21/07/2011 Yes Approved 21/07/2011 Date Specified Approved 05/11/2011 Date Specified Date Specified Date Specified Date Specified Approved 11/08/2011 Approved 10/06/2011 Date Specified t Available page 5 / 10

6 Regulatory Clearance Status from DCGI Health Condition / Problems Studied Intervention / Comparator Agent Inclusion Criteria Institutional review Board, St. Johns Medical College Approved 20/10/2011 Mag POWERIEC Approved 02/04/2011 Yes MagPower Independent Ethics Committee Approved 02/04/2011 Yes MaGpOwErIEC Approved 06/06/2011 Yes MagpowerIndependent EthicsCommittee Status t Applicable Health Type Patients Approved 18/04/2011 Yes Date Date Specified Condition CHEMO-NAIVE ADULT CHRONIC LYMPHOCYTIC LEUKEMIA PATIENTS Type Name Details Intervention Bendamustine+Rituximab Rituximab administered only on Day 1 and Bendamustine administered on Days 2 and 3 of each cycle. Cycles are to be repeated every 4 weeks (28 days). Rituximab will be administered intravenously at a dose of 375 mg/m2 according to standard procedures. Comparator Agent t Applicable t Applicable Age From Age To Gender Details Year(s) Year(s) Both Inclusion Criteria 1.Male or female patients between ages of 18 to 81 years (both years inclusive). 2.ECOG performance score of less than or equal to 2. 3.Untreated case of chronic lymphocytic leukemia. 4.Organ and marrow function as defined below: a.absolute neutrophil count: greater than or equal to 1.5 x 109 cells/l b.hemoglobin: greater than or equal to 9 g/dl c.platelets: greater than or equal to 75 x 109 cells/l d.lymphocyte count greater than or equal to 5x109 cells/l e.serum creatinine: less than 1.5 of ULN 5.Measurable in terms of a.lymphocytes presence or b.measurable Lymphadenopathy or page 6 / 10

7 Exclusion Criteria Details c.bone marrow involvement greater than 30 percent 6.For female patients of child-bearing potential, a negative urine pregnancy test at Screening. 7.Current use of an acceptable form of double-barrier birth control: a). female patients of childbearing potential must agree to use acceptable methods of birth control which include oral, injectable, transdermal or implantable hormonal contraceptives, intrauterine device, cervical diaphragm plus spermicide, or female condom plus spermicide during the study period and for 30 days after the last administration of drugs; b) male patients must also agree to use acceptable methods of birth control with their partners and this may include use of a male condom plus spermicide; if the patient is practicing abstinence at the time of Screening, he/she must agree to use a double-barrier contraceptive method if he/she becomes sexually active. 8.Life expectancy should be at least 1 to 2 years as per the discretion of the investigator. Exclusion Criteria 1.Patients with history of any other cancer. 2.Patients with known brain or other central nervous system disease. 3.Patients with serious concomitant systemic disorders incompatible with the study, at the discretion of the investigator. 4.Patients with any major organ malfunction. 5.Patients with a weakened immune system. 6.Patients with fever or other signs of infection at the time of screening that could interfere with the patients ability to participate in the study 7.Patients with severe skin problems. 8.Patients with severe mouth ulcers. 9.Patients with metabolic disorders. 10.Patient with electrolyte imbalances. 11.Patients who have a known history of Systemic Lupus Erythematosus. 12.Patients with the history of heart diseases. e.g., NYHA Functional Class III or IV heart failure, myocardial infarction within 6 months, ventricular tachy- arrhythmias requiring ongoing treatment, or unstable angina, or heart rhythm disorder. 13.Patients with the history of kidney failure and need dialysis. 14.Patients with the history of lung disease / breathing disorder / upper respiratory tract infection / other severe or chronic pulmonary diseases that could interfere with the patients ability to participate in the study. page 7 / 10

8 15.Patients with the history of Progressive multifocal leukoencephalopathy. 16.Patients with the history of bowel obstruction and perforation. 17.Patients with the problem of severe constipation. 18.Patients with the history of gastrointestinal disorders like nausea, vomiting, and diarrhea that could interfere with the patients ability to participate in the study. 19.Patients with the history of psychological problems that would preclude participation in the study (like confusion, hallucination, loss of balance, change in the way one walks or talks, decreased strength or weakness on one side of your body, blurred vision or loss of vision). 20.Patients with AST greater than or equal to 2.5 of ULN. 21.Patients with ALT greater than or equal to 2.5 of ULN. 22.Patients with Bilirubin greater than or equal to 1.5 of ULN. 23.Patients with Creatinine Clearance of less than 40mL/min. 24.Patients with Hyperuricemia at the discretion of the investigator. 25.Patients with high potassium levels at the discretion of the investigator. 26.Patients with high calcium levels at the discretion of the investigator. 27.Patients with the symptoms of flu at the time of screening that could interfere with the patients ability to participate in the study. 28.Patients with clinically significant bleeding event within the last 3 months, unrelated to trauma, or underlying condition that would be expected to result in a bleeding diathesis. 29.Patients with a known history of HIV. 30.Patients who are allergic to mouse proteins in general. 31.Patients who have had a vaccination recently or are scheduled to receive vaccinations. 32.Patients with a known hypersensitivity to Bendamustine. 33.Patients with a known hypersensitivity to Mannitol. 34.Patients with known hypersensitivity to the Rituximab. 35.Patients who are taking other anticancer agents. 36.Patients who are taking the other medications which cause myelosuppression. 37.Patients who are taking Fluvoxamine. 38.Patient who are taking Ciprofloxacin. page 8 / 10

9 39.Patient who are taking Omeprazole. 40.Patient who are taking Cisplatin. 41.Patients already documented positive for the viruses like HBV, HCV, CMV, HSV, Parovirus B19, Varicella Zoster virus and West Nile virus. 42.Patients for whom, in the opinion of the investigator, their general status would not permit the administration of Bendamustine and Rituximab or meet any of the study endpoints. 43.Patients with the habit of smoking. 44.Patients who are hypertensive. 45.Inability of the patient &/or Legally Acceptable Representative to give the informed consent. 46.Patients who are participating in another clinical trial currently. 47.Female patients who are pregnant or planning a pregnancy during the study period. 48.Patients who are lactating mothers. Method of Generating Random Sequence Method of Concealment Blinding/Masking t Applicable t Applicable Open Label Primary Outcome Outcome Timepoints To study the Response Rate of Bendamustine and Rituximab combination in chemo-naive chronic lymphocytic leukemia patients. End of the treatment period of 7 months. Secondary Outcome Outcome Timepoints Target Sample Size Phase of Trial 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 To study the Toxicity (Safety) of Bendamustine and Rituximab combination in chemo-naive chronic lymphocytic leukemia patients. Total Sample Size=50 Sample Size from India=50 N/A 13/05/2011 Date Specified Years=0 Months=7 Days=10 t Applicable Completed End of the treatment period. Patients will receive a maximum of six cycles of treatment with Bendamustine plus Rituximab (BR), with Rituximab administered only on Day 1 and Bendamustine administered on Days 2 and 3 of page 9 / 10

10 Powered by TCPDF ( each cycle. Cycles are to be repeated every 4 weeks (28 days). Rituximab will be administered intravenously at a dose of 375 mg/m2 according to standard procedures. Premedication consisting of acetaminophen and diphenhydramine should be considered before each infusion of Rituximab. Bendamustine will be administered intravenously at a dose of 100 mg/m2 per day during a 30-minute time period after diluting in 500ml of normal saline. After 4 weeks of the last cycle, single doses of Rituximab(375 mg/m2) will be administered intravenously according to standard procedures. Before starting each cycle, the laboratory assessments (Hematology, Biochemistry & Urinalysis) should be performed followed by the administration of the study drug(s). The response of the disease to the treatment will be assessed through the blood counts. All other safety parameters will be performed as per the schedule. page 10 / 10