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1 Clinical Trial Details (PDF Generation Date :- Mon, 18 Mar :33:59 GMT) CTRI Number CTRI/2009/091/ [Registered on: 24/09/2009] - Last Modified On 26/05/2016 Post Graduate Thesis Type of Trial Type of Study Study Design Public Title of Study Scientific Title of Study No Interventional Drug Biological Randomized, Parallel Group, Active Controlled Trial OMB : Ofatumumab Added to Fludarabine-Cyclophosphamide vs. Fludarabine-Cyclophosphamide Combination in Relapsed Subjects With Chronic Lymphocytic Leukemia OMB : A Phase III, Open Label, Randomized Trial of Ofatumumab Added to Fludarabine-Cyclophosphamide vs. Fludarabine-Cyclophosphamide Combination in Subjects With Relapsed Chronic Lymphocytic Leukemia Secondary IDs if Any Secondary ID Identifier Details of Principal Investigator or overall Trial Coordinator (multi-center study) NCT OMB UM2007/00310/03 Designation ClinicalTrials.gov Other Protocol Number Details of Principal Investigator Not Applicable N/A Details Contact Person (Scientific Query) Details Contact Person (Public Query) Phone Fax Details Contact Person (Scientific Query) Dr Vrishali Desai Designation Head-Medical Affairs Phone Fax Designation GlaxoSmithKline Pharmaceuticals Ltd. GlaxoSmithKline Pharmaceuticals Ltd. Dr. Annie Besant Road, Worli vrishali.r.desai@gsk.com Details Contact Person (Public Query) Kedar Nayak Area Manager_In-Country Clinical Operations GlaxoSmithKline Pharmaceuticals Ltd GlaxoSmithKline Pharmaceuticals Ltd Dr. Annie Besant Road, Worli page 1 / 5

2 Source of Monetary or Material Support Primary Sponsor Details of Secondary Sponsor Countries of Recruitment Sites of Study Phone Fax > GlaxoSmithKline Pharmaceuticals Ltd. Source of Monetary or Material Support Primary Sponsor Details GlaxoSmithKline Pharmaceuticals Ltd Dr. Annie Besant Road, Worli, Type of Sponsor Nil List of Countries Brazil Bulgaria Canada Germany Greece Italy Mexico Netherlands Poland Romania Russian Federation Spain Taiwan Thailand Ukraine United Kingdom United States of America of Principal Investigator Dr Sameer Bakhshi Pharmaceutical industry-global of Site Site Phone/Fax/ All Institute of Medical Sciences Institute Rotary Cancer Hospital, Ansari Nagar New Delhi DELHI Dr. Usha Agarwal Haematology Centre 2nd Floor, Ghamat Lodge,,804/A, Dr. B. Ambedkar Road,Above ING Vyasya Bank, Dr. K. Govindbabu Kidwai Memorial Institute of Oncology Project Room, Jindal Block, Dr. M. H. Marigowda Road, Bangalore m page 2 / 5

3 Details of Ethics Committee Regulatory Clearance Status from DCGI Health Condition / Problems Studied Intervention / Comparator Agent Dr Minish Jain Ruby Hall Clinic- Cancer Center Dr Seema Bhatwadekar Sterling Hospital KARNATAKA 40, Sassoon Road, Pune Pune Opp. Inox Multiplex, Race course Circle (West), Vadodara, Gujarat , Vadodara GUJARAT Dr. Manju Sengar Tata Memorial Hospital Dr. E. Borges Road, Parel, minishjain009@gmail.c om ssbkar16@gmail.com manju.sengar@gmail.c om of Committee Approval Status Date of Approval Is Independent Ethics Committee? Ethics Committee of Poona Medical Research Foundation Institutional Ethics Committee, All Institute Of Medical Sciences Institutional Ethics Committee, Tata Memorial Centre Medical Ethics Committee, Kidwai Memorial institute of Oncology Safety, Health & Welfare - Ethics Committee Sterling Hospital, Ethics Committee, Vadodara Status Approved 19/03/2011 No Approved 08/10/2009 No Approved 12/04/2010 No Approved 03/09/2009 No Approved 31/01/2015 No Submittted/Under Review No Date Specified Date Approved/Obtained 11/09/2009 Health Type Patients Condition No Relapsed Chronic Lymphocytic Leukemia Type Details Intervention Ofatumumab, Fludarabine, Cyclophosphamide Drug: OFC Infusion Ofatumumab Cycle 1-Day 1 300mg, Cycle 1-Day mg, then Cycles 2-6 Day mg every 28 days, Fludarabine 25mg/m2 Days 1-3 every 28 days for 6 cycles, Cyclophosphamide 250 mg/m2 Days 1-3 every 28 days for 6 cycles Comparator Agent Fludarabine, Cyclophosphamide Fludarabine 25mg/m2 Days 1-3 every 28 days for 6 cycles, Cyclophosphamide 250mg/m2 Days 1-3 every 28 days for 6 page 3 / 5

4 Inclusion Criteria Exclusion Criteria Age From Age To Gender Details Details Year(s) 0.00 Year(s) Both Inclusion Criteria cycles Inclusion Criteria: Flow cytometry confirmation of immunophenotype with CD5, CD19, CD20, CD23, CD79b, and surface Ig prior to Visit 2 Active disease and indication for treatment based on modified IWCLL updated NCIWG guidelines defined by presenting at least one of the following conditions: Evidence of progressive marrow failure as manifested by development of, or worsening of anemia, and/or thrombocytopenia Massive (i.e., greater than 6 cm below the left costal margin) or progressive or symptomatic splenomegaly Massive nodes (i.e., greater than 10 cm in longest diameter) or progressive or symptomatic lymphadenopathy Progressive lymphocytosis with an increase of more than 50% over a 2 month period or lymphocyte doubling time of less than 6 months A minimum of any one of the following disease-related symptoms must be present: Unintentional weight loss more than or equal to 10% within the previous 6 months Fevers >100.5ºF (38.0ºC) for? 2 weeks without other evidence of infection Night sweats for more than 1 month without evidence of infection Relapsed CLL: defined as a subject who has received at least one prior CLL therapy and previously achieved a complete or partial remission/response, but after a period of? 6 months, demonstrate evidence of disease progression [Hallek, 2008] ECOG Performance Status of 0-2 Life expectancy of at least 6 months Age? 18 years Signed written informed consent prior to performing any study-specific procedures Exclusion Criteria Exclusion Criteria: Refractory CLL: defined as treatment failure (failure to achieve a CR or PR) or disease progression within 6 months of last anti-leukemic therapy [Hallek, 2008] Subjects with platelet count less than 50,000/microliter and ANC? 1000/microliter Previous autologous or allogeneic stem cell transplantation Active autoimmune hemolytic anemia requiring corticosteroid therapy more than 100mg equivalent to hydrocortisone, or chemotherapy. Subjects can participate if in the opinion of investigator and medical monitor it is thought not to affect the subject s safety, the conduct of the study or the interpretation of the data. Known CLL transformation (Richter) or CNS involvement or clinically significant cardiac disease Chronic/current infectious disease requiring systemic antibiotics/antifungal/antiviral treatment Other past or current malignancy. Subjects who have been free of malignancy for at least 5 years, or have a history of completely resected non-melanoma skin cancer, or successfully treated in situ carcinoma are eligible. Subjects can participate if in the opinion of investigator and medical monitor it is thought not to affect the subject s safety, the conduct of the study or the interpretation of the data. page 4 / 5

5 Powered by TCPDF ( Method of Generating Random Sequence Method of Concealment Blinding/Masking Computer generated randomization Pre-numbered or coded identical Containers Open Label History of significant cerebrovascular disease or event with significant symptoms or sequelae Glucocorticoid use, unless given in doses? 100mg/day hydrocortisone (or equivalent dose of other glucocorticoid) for less than 7 days for exacerbations other than CLL (e.g. asthma) Known HIV positive, Positive serology for Hepatitis B (HB) Screening laboratory values: Creatinine more than 2.0 times upper normal limit (unless normal creatinine clearance) Total bilirubin more than 2.0 times upper normal limit (unless due to liver involvement of CLL) Alanine transaminase (ALT) more than 3.0 times upper normal limit (unless due to liver involvement of CLL) Lactating women, women with a positive pregnancy test at Visit 1 or women Primary Outcome Outcome Timepoints Progression-free-survival Time Frame: 3 years Secondary Outcome Outcome Timepoints Target Sample Size Phase of Trial Phase 3 Date of First Enrollment () Date of First Enrollment (Global) Estimated Duration of Trial Recruitment Status of Trial (Global) Recruitment Status of Trial () Publication Details Brief Summary Clinical benefit, safety, tolerability, changes in patient reported outcome measures and pharmacokinetics. Total Sample Size=352 Sample Size from =40 05/03/ /03/2009 Years=7 Months=6 Days=0 Completed Completed Time Frame: 3 years Fludarabine is currently approved for treatment of relapsed Chronic Lymphocytic Leukemia. Studies have shown that drugs in combination with fludarabine have shown more effectiveness than fludarabine alone. The addition of ofatumumab to fludarabine-cyclophosphamide combination offers potentially a more effective therapy, without additional toxicity. The objective of this study is to determine the effect of ofatumumab added to fludarabine and cyclophosphamide in patients with Chronic Lymphocytic Leukemia who have responded previously to therapy but later develop progressive disease and require additional therapy. 29 patients have been recruited from. First patient was enrolled on 5th March 2010 and last patient was enrolled on 19th January Currently all patients have completed the treatment period and are in post treatment or overall survival follow up. page 5 / 5