CTRI

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CTRI Number

CTRI/2012/03/002502 [Registered on: 20/03/2012] Trial Registered Retrospectively

Last Modified On:

20/03/2012

Post Graduate Thesis

Type of Trial

Interventional

Type of Study

Drug

Study Design

Other

Public Title of Study

A study of Rituximab in patients with Non Hodgkins Lymphoma a type of cancer

Scientific Title of Study

A Prospective, Comparative, Randomized, Multicenteric, Phase III study of Rituximab in Patients with NHL

Trial Acronym

Secondary IDs if Any

Secondary ID	Identifier
IBPL_RT_01Version 2.0 dated 29/08/11	Protocol Number

Details of Principal Investigator or overall Trial Coordinator (multi-center study)

Name	Dr Pranjal Bordoloi
Designation	Head- Medical Services
Affiliation	IBPL
Address	Intas Biopharmaceuticals Ltd Safal Pegasus 904-909 A Block Nr. Prahlad Nagar Garden Anand Nagar Satellite Ahmedabad 380015 Ahmadabad GUJARAT 380015 India
Phone	07966074100
Fax
Email	pranjal.bordoloi@intasbiopharma.co.in

Details of Contact Person
Scientific Query

Name	Dr Pranjal Bordoloi
Designation	Head- Medical Services
Affiliation	IBPL
Address	Intas Biopharmaceuticals Ltd Safal Pegasus 904-909 A Block Nr. Prahlad Nagar Garden Anand Nagar Satellite Ahmedabad 380015 Ahmadabad GUJARAT 380015 India
Phone	07966074100
Fax
Email	pranjal.bordoloi@intasbiopharma.co.in

Details of Contact Person
Public Query

Name	Dr Pranjal Bordoloi
Designation	Head- Medical Services
Affiliation	IBPL
Address	Intas Biopharmaceuticals Ltd Safal Pegasus 904-909 A Block Nr. Prahlad Nagar Garden Anand Nagar Satellite Ahmedabad 380015 Ahmadabad GUJARAT 380015 India
Phone	07966074100
Fax
Email	pranjal.bordoloi@intasbiopharma.co.in

Source of Monetary or Material Support

IBPL

Primary Sponsor

Name	INTAS BIOPHARMACEUTICALS LTD
Address	Intas Biopharmaceuticals Ltd. Plot No. 423 / P / A Sarkhej - Bavla Highway, Moraiya, Taluka - Sanand, 382 210 Ahmedabad, Gujarat India.
Type of Sponsor	Pharmaceutical industry-Indian

Details of Secondary Sponsor

Name	Address
Oncology Services India Ltd	Oncololgy Services India Ltd 904-909 Safal Pegasus A Block Nr Prahlad Nagar Garden Satellite Ahmedabad 380 015 Gujarat India

Countries of Recruitment

India

Sites of Study

No of Sites = 28
Name of Principal Investigator	Name of Site	Site Address	Phone/Fax/Email
Dr Jayanti Patel	Apple Hospital	Dept Clinical Research Udhna darwaja Ring road Surat 395001 Surat GUJARAT	9825121347 prakrutijay@hotmail.com
Dr J Jebasingh	Asirvatham speciality Hospital	Dept Clinical Research Rajaji Street Gandhi Nagar Madurai 625020 Tamil Nadu India Madurai TAMIL NADU	9789292990 asirvath.cr@gmail.com
Dr Jaiprakash Baraskar	Baraskar Hospital & Research Centre	276 Crystal Plaza Dept Clinical Research Central Bazaar Road Ramdaspeth Nagpur 440 010 Maharashtra India Nagpur MAHARASHTRA	9422108822 jpcancercareclinic2005@yahoo.co.in
Dr Kunjahari Medhi	Batra Hospital & Medical Research Centre	1 Tughlakabad Institutional Area Mehrauli Badarpur Road New Delhi 110062 India New Delhi DELHI	9818884856 medhiaiims@gmail.com
Dr Tanveer Maksud	Bharat Cancer Hospital	Bharat Cancer Hospital & Research Institute Dept Clinical Research Surat Bardoli Road Saroli Dist Surat 395 010 Gujarat India Surat GUJARAT	9909918887 tanveermaksud@yahoo.com
Dr Smita Gupte	Cancer Clinic	2ndFloor Shriwardhan Complex Dept Oncology Near Landmark Wardha Road Ramdaspeth Nagpur 440012 Maharashtra India Nagpur MAHARASHTRA	9373107176 smita_gupte@rediffmail.com
Dr Shriram B Kane	Cancer Haematology Oncology Clinic	Swapnil Apts Abhayankar road Dhantoli Nagpur 440012 Maharashtra India Nagpur MAHARASHTRA	9823012851 shriramkane@gmail.com
Dr Ajay Mehta	Central India Cancer Research Institute	11 Shankar Nagar Dept Oncology Nagpur 440010 Maharashtra India Nagpur MAHARASHTRA	9823190192 ajayonco@hotmail.com
Dr Ashish Kaushal	Dr Ashish Kaushal	HCG Medisurge Hospital Dept Oncology 301 Arth Complex Mithakali six Roads Ahmedabad 380 006 Gujarat India Ahmadabad GUJARAT	9824048666 drashish4@yahoo.co.in
Dr Kiran Shah	Dr Kiran Shah	Private Clinic, 135 Shankheshwar Complex Majura Gate Surat 395002 Gujarat India Surat GUJARAT	9825140157 kcs_haem@yahoo.co.in
Dr Rajeev Gupta	Fortis Escorts Hospital	Fortis Escorts Hospital Clinical Research Dept Amritsar 143004 Amritsar PUNJAB	9781709615 drrajeevgupta1@gmail.com
Dr Arun Seshachalam	G. Viswanatham Hospital	Singarathope Clinical Research Dept Trichy 620008 Tamil Nadu India Tiruchirappalli TAMIL NADU	8939324070 gvn.research@gmail.com
Dr AK Ganju	Ganju Haematology clinic & hospital	Haemato oncology Dept 6th floor Midas Heights Central Bazar Road Ramdeshpeth Nagpur Nagpur MAHARASHTRA	9422119765 avatarganju@yahoo.com
Dr Vinay Vyas	Goyal Hospital & Research Centre	961/3 Residency Road Dept Oncology Opp Rotary Hall Jodhpur 342003 Rajasthan India Jodhpur RAJASTHAN	9413063148 vinay25vyas@gmail.com
Dr Katiyar Raj Kishore	J K Cancer Institute	GSVM Medical College Dept. of Radiotherapy Rawatpur Kanpur 208 002 Uttar Pradesh India Kanpur Nagar UTTAR PRADESH	9415074510 doctorkatiyar@yahoo.co.in
Dr Mithun Shah	Jagmohan hospital	Behind old high court Dept clinical research Navrangpura 380009 Gujarat Ahmedabad Ahmadabad GUJARAT	9879770127 jagmohanhospital@gmail.com
Dr Uday Deotare	Kedar	Dept Oncology 301 Kedar Nr Parimal Garden Opp Krupa Petrol Pump Ellisbridge Ahmedabad 380006 Ahmadabad GUJARAT	07926465890 drdeotareuday@rediffmail.com
Dr Rajeev Pant	Lucknow Cancer Institute	1 Manasnagar Jiamau Hazratgunj Clinical Research DeptLucknow 226 001 Uttar Pradesh India Lucknow UTTAR PRADESH	9506033102 rajonco123@yahoo.com
Dr Rajesh Makadia	Mangalam Hospital	Oncology Dept Opp Prasang Hall Near KKV Hall 150 ft ring road Rajkot 360005 Rajkot GUJARAT	9824255668 makadiamonali@yahoo.co.in
Dr Anup Majumdar	Nightangle Hospital	Radiation Oncology Department 11 Shakespeare Sarani Kolkata 700071 West Bengal India Kolkata WEST BENGAL	9830152485 anup.majumdar@gmail.com
Dr Shishir Seth	Rajiv Gandhi Cancer Institute And Research Centre	Department of Haemato Oncology Sector 5 Rohini Delhi-110085, India New Delhi DELHI	9013586776 drssrseth@gmail.com
Dr Anu Tiwari	Ratan Cancer Hospital & Research Institute	Radiation Oncology Department 113/103 A Swaroop Nagar Kanpur 208002 Uttar Pradesh India Kanpur Nagar UTTAR PRADESH	9450093066 anu412@rediffmail.com
Dr Chandrashekhar Tamane	Seth Nandlal Dhoot Hospital	A-1 MIDC Chikalthana Dept Clinical Research Aurangabad 431 210 Maharashtra India Aurangabad MAHARASHTRA	9225316906 chandratamane@yahoo.com
Dr Mitesh Halvawala	Shree B.D. Mehta Mahavir Heart Institute	Haematology Department Shree Mahavir Heart Campus Ring Road Surat 395001 Gujarat India. Surat GUJARAT	982510995 drmitesh@ymail.com
Dr Milindkumar Wankhede	Shreeji Multispeciality Hospital & Research Centre	Clinical Research Dept Castle Rock 2nd Floor Canada Corner Nasik 422005 Maharashtra India Nashik MAHARASHTRA	9970283245 drmilindwankhede@gmail.com
Dr Pradeep R Shah	Shreyas Medical Clinic	2 Premal Appartment Near GPO Raopura Vadodara 390 001 Gujarat India Vadodara GUJARAT	02652425083 pradeeprshah@msn.com
Dr Uttam Soni	Sita Devi Hospital	Dept Clinical Research 75 Shriram Colony Behind Chambal Grid Hawa Sadak Jaipur 302006 India. Jaipur RAJASTHAN	9602047858 soniuttam@hotmail.com
Dr Sulabhchandra Bhamare	Sonawane Hospital	Dept Cinical Research Maratha Mandir Red cross Lane M.G. Road Nashik 422002 Maharashtra India Nashik MAHARASHTRA	9373244670 drsulabhchandra@yahoo.co.in

Details of Ethics Committee

No of Ethics Committees= 28
Name of Committee	Approval Status
Ethic_Surat_DrKiranShah	Approved
Ethic_Surat_DrMitesh	Approved
Ghcec_Nagpur_DrSmitaGupte	Approved
GVishwanatham_Trichy_DrArunSeshachalam	Approved
HCGMedisurgeEthicsCommittee_Ahmedabad_DrAshishKaushal	Approved
IECAditya_Ahmedabad_DrUday	Approved
IECAditya_Amritsar_DrRajeevGupta	Approved
IECAditya_Aurangabad_DrTamane	Approved
IECAditya_Jaipur_DrUttamSoni	Approved
IECAditya_Jodhpur_DrVinayVyas	Approved
IECAditya_Kanpur_DrKatiyar	Approved
IECAditya_Kanpur_DrTiwari	Approved
IECAditya_Lucknow_DrPant	Approved
IECAditya_Nagpur_DrAjayMehta	Approved
IECAditya_Nagpur_DrGanju	Approved
IECAditya_Nagpur_DrJayprakashBaraskar	Approved
IECAditya_Nagpur_DrKane	Approved
IECAditya_Nashik_DrBhamare	Approved
IECAditya_Nashik_DrWankhede	Approved
IECAditya_NewDelhi_DrMedhi	Approved
IECAditya_Rajkot_DrMakadia	Approved
IECAditya_Surat_DrJayantiPatel	Approved
IECAditya_Surat_DrMaksud	Approved
IECAditya_Vadodara_DrPRShah	Approved
IRB-Asirvatham_Madurai_DrJJebasingh	Approved
IRB-RajivGandhiCancerInstituteandResearchCentre_NewDelhi_DrShishirSethDrSheth	Approved
NightangleEthicsCommittee_Kolkata_DrAnupMajumdar	Approved
SujlamIEC_Ahmedabad_DrMithunShah	Approved

Regulatory Clearance Status from DCGI

Status

Approved/Obtained

Health Condition / Problems Studied

Health Type	Condition
Patients	CD20-positive diffuse large B-cell or follicular lymphoma; NHL patients,

Intervention / Comparator Agent

Type	Name	Details
Comparator Agent	Mabthera	Mabthera- 375 mg/m2 (IV) BSA for 2 cycles
Intervention	Rituximab	Rituximab - 375 mg/m2 (IV) BSA for 2 cycles

Inclusion Criteria

Age From	18.00 Year(s)
Age To	80.00 Year(s)
Gender	Both
Details	Inclusion criteria Adult men and women greater or equal to 18 years Patients with histologically confirmed diffuse large B-cell CD20 positive NHL or follicular B-cell Lymphoma Subjects with a performance status of 0 to 2 according to the Eastern Cooperative Oncology Group (ECOG) Normal hematopoietic hepatic and renal function as follows Absolute neutrophil count (ANC) greater than or equal to 1000 per mm3 (unless due to non-Hodgkins lymphoma (NHL) bone marrow involvement) AST ALT less than or equal to 3 multiplied ULN Bilirubin less than or equal 1.5 multiplied ULN Serum creatinine less than 1.5 multiplied ULN Woman of child bearing potential (entering the study after a menstrual period and who have a negative pregnancy test) must agree to use medically acceptable forms of contraception during the study and for three months after the last treatment intake Patients able to understand and voluntarily provide written informed consent before screening following an explanation of the nature and purpose of this study No other serious disease or medical condition that would interfere with compliance

ExclusionCriteria

Details

Patients who had prior anti CD20 therapy

Hypersensitivity to Rituximab

Any other malignancy in the last 2 years other than non-Hodgkins
Lymphoma

Any history or presence of clinically significant cardiovascular
Respiratory hepatic renal hematologic gastrointestinal endocrine
immunologic dermatologic neurologic or psychiatric disease or any
other condition which in the opinion of the Investigator could
jeopardize the safety of the subject or the validity of the study results

According to investigators opinion patients general status do not
permit the administration of CHOP

Pregnant or breast-feeding patients (for female patients of child
bearing potential)

Have received any Investigational product in last 30 days or going to
receive any Investigational product during the study period

Suspected or confirmed poor compliance according to investigators
judgment in completing the trial and follow up

Method of Generating Random Sequence

Not Applicable

Method of Concealment

Centralized

Blinding/Masking

Open Label

Primary Outcome

Outcome	TimePoints
Objective Response rate; Safety endpoints,AE evaluation, anti-rituximab antibody development	21 days cycle

Secondary Outcome

Outcome	TimePoints
Pharmacokinetic assessment	in cycle 1

Target Sample Size

Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials"

Phase of Trial

Phase 3

Date of First Enrollment (India)

19/10/2011

Date of Study Completion (India)

Applicable only for Completed/Terminated trials

Date of First Enrollment (Global)

Date Missing

Date of Study Completion (Global)

Applicable only for Completed/Terminated trials

Estimated Duration of Trial

Years="0"
Months="6"
Days="0"

Recruitment Status of Trial (Global)

Not Applicable

Recruitment Status of Trial (India)

Open to Recruitment

Publication Details

Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?

Brief Summary

This is a Phase III, Randomized, Comparative, Multicenteric study. This
will be a study where patients with previously untreated diffuse large Bcell, CD20-positive NHL will receive Rituximab of Intas Biopharmaceuticals Ltd and CHOP against MabThera of Roche and CHOP. Total of 100 patients will be randomized in ratio of 3:1. The study duration is for 2 cycles.