CTRI

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CTRI Number

CTRI/2012/04/002587 [Registered on: 19/04/2012] Trial Registered Prospectively

Last Modified On:

09/03/2020

Post Graduate Thesis

Type of Trial

Interventional

Type of Study

Biological

Study Design

Randomized, Parallel Group, Active Controlled Trial

Public Title of Study

A study of GP2013 in the Treatment of Patients With Previously Untreated, Advanced Stage Follicular Lymphoma (a type of cancer)

Scientific Title of Study
Modification(s)

A randomized, controlled, double-blind Phase III trial to compare the efficacy, safety and pharmacokinetics of GP2013 plus cyclophosphamide, vincristine, prednisone vs. MabTheraÂ® plus cyclophosphamide, vincristine, prednisone, followed by GP2013 or MabTheraÂ® maintenance therapy in patients with previously untreated, advanced stage follicular lymphoma

Trial Acronym

ASSIST-FL

Secondary IDs if Any
Modification(s)

Secondary ID	Identifier
GP13 - 301 (Version 5.0 dated 10 Nov 2014)	Protocol Number
NCT01419665	ClinicalTrials.gov

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

Name
Designation
Affiliation
Address
Phone
Fax
Email

Details of Contact Person
Scientific Query
Modification(s)

Name	Arun Sundriyal
Designation	Director, Clinical Management & Head of Central Asia
Affiliation	PPD Pharmaceutical Development India Pvt. Ltd.
Address	PPD Pharmaceutical Development India Pvt Ltd., Vatica City Point, 11th Floor, Sector 25 Mehrauli Gurgaon Road, Gurgaon â€“ 122002, India Gurgaon HARYANA 122002 India
Phone	911244739903
Fax	1244739999
Email	Arun.Sundriyal@ppdi.com

Details of Contact Person
Public Query
Modification(s)

Name	Arun Sundriyal
Designation	Director, Clinical Management & Head of Central Asia
Affiliation	PPD Pharmaceutical Development India Pvt. Ltd.
Address	PPD Pharmaceutical Development India Pvt Ltd., Vatica City Point, 11th Floor, Sector 25 Mehrauli Gurgaon Road, Gurgaon â€“ 122002, India Gurgaon HARYANA 122002 India
Phone	911244739903
Fax	1244739999
Email	Arun.Sundriyal@ppdi.com

Source of Monetary or Material Support

Hexal AG, Industriestr.25, D- 83607 Holzkirchen, Germany

Primary Sponsor

Name	Hexal AG
Address	Hexal AG, Industriestr.25, D- 83607 Holzkirchen, Germany
Type of Sponsor	Pharmaceutical industry-Global

Details of Secondary Sponsor

Name	Address
PPD Pharmaceutical Development India Pvt Ltd	01-Dynasty B-Wing (Kanakia Spaces) Andheri-Kurla Road, Andheri East, Mumbai-400059, India

Countries of Recruitment
Modification(s)

Argentina
Australia
Brazil
Bulgaria
Colombia
France
Germany
Hungary
India
Israel
Malaysia
Netherlands
Peru
Portugal
Romania
Russian Federation
Spain
Ukraine
Austria
Japan
Greece
Ireland
Italy
New Zealand
Poland
South Africa

Sites of Study
Modification(s)

No of Sites = 34
Name of Principal Investigator	Name of Site	Site Address	Phone/Fax/Email
Dr S V S S Prasad	Apollo Hospitals	Department of Oncology, Apollo Health City, Apollo Hospitals, Jubilee Hills - 500096 Hyderabad ANDHRA PRADESH	919848018804 914023543270 hydaherf@gmail.com
Dr Thirumalairaj Raja	Apollo Speciality Hospital	Apollo Speciality Hospital 320, Padma Complex, Nandaram, Mount Road- 600035 Chennai TAMIL NADU	919841070195 rajatraj@yahoo.com
Dr Naresh Somani	Bhagwan Mahaveer Cancer Hospital & Research Centre	JLN Marg, Malviya Nagar, Jaipur - 302017, Rajasthan, India Jaipur RAJASTHAN	9829014996 drsomani@somexresearch.com
Dr Tanveer Maksud	Bharat Cancer Hospital & Research Institute	Bharat Cancer Hospital & Research Institute, (Managed by Shri Bhartimaiya Memorial Foundation), Manav Daya Trust Complex, Surat-Bardoli Road, Saroli - 395010 Surat GUJARAT	912612641000 tanveermaksud@yahoo.com
Dr Ajay Mehta	Central India Cancer Research Institute	Central India Cancer Research Institute, 11 Shankar Nagar, WHC road - 440010 Nagpur MAHARASHTRA	917122520956 917122562483 ajayonco@hotmail.com
Dr Anu Korula	Centre for Stem Cell Research, Christian Medical College	Department if Haematology, Christian Medical College, Ida Scudder Road, Vellore - 632004 Vellore TAMIL NADU	914162282352 914162226449 anukorula@cmcvellore.ac.in
Dr Kalyan Kusum Mukherjee	Chittaranjan National Cancer Institute	Medical Oncology, Chittaranjan National Cancer Institute 37, SP Mukherjee Road Kalighat PO-700026 Kolkata WEST BENGAL	919830115905 913324757606 kkmukherjee4u@hotmail.com
Dr Rajnish Nagarkar	Curie Manavata Cancer Centre	Curie Manavata Cancer Centre Opposite Mahamarg Bus Stand, Mumbai Naka - 422004 Nashik MAHARASHTRA	919823061929 912532592666 drraj@manavatacancercentre.com
Dr Chetan Deshmukh	Deenanath Mangeshkar Hospital (DMH) & Research Center	Department of Oncology, Deenanath Mangeshkar Hospital (DMH) & Research Center Erandawne, 411001 Pune MAHARASHTRA	912040151968 912066023025 drchetandeshmukh@gmail.com
Dr Rajeev Gupta	Fortis Healthcare	Majitha - Verka Bypass Road-143004, India Amritsar PUNJAB	91183301222 rajeev.gupta2@fortishealthcare.com
Dr Sandip Abhay Kumar Shah	Gujarat Cancer and Research Institute	Department of Oncology, Clinical Trial Wing, 3rd Floor, Nr. Day Care Chemotherapy Unit: No. 7, New Civil Hospital Campus, Asarwa - 380016 Ahmadabad GUJARAT	919824041170 sandip60@yahoo.com
Dr Radhesyam Naik	HCG Bangalore Institute of Oncology	HCG Towers, No.8, P Kallinga Road,Sampangiram Nagar- 560027 Bangalore KARNATAKA	919731310682 918033466059 radheshyam_n@yahoo.com
Dr K Govind Babu	HCG-Curie Centre of Oncology	No. 88, 17th â€˜Aâ€™ Main,2nd Cross, 5th block, Koramangala -560034 Bangalore KARNATAKA	919845072940 kgblaugh@gmail.com
Dr Senthil Rajappa	Indo American Cancer Institute & research center	Department of Medical Oncology Road No. 10, Banjara Hill-500034 Hyderabad ANDHRA PRADESH	91402355253 91402354212 siddharth142@sify.com
Dr Harsh Dua	Indraprastha Apollo Hospitals	Department of Oncology Sarita Vihar Delhi-Mathura Road-110044 New Delhi DELHI	911412232409 911412233337 drharshdua@yahoo.co.in
Dr Uttam Kumar Nath	Institute of Haematology and Transfusion Medicine (IHTM)	3rd Floor MCH Building, Medical College Kolkata,88- College street-700073 Kolkata WEST BENGAL	9433982756 nath.uttam@gmail.com
Dr Reetu Jain	Jaslok Hospital and Research Centre	Jaslok Hospital and Research Centre 15,Dr.G.Deshmukh Marg Mumbai-400026 , Maharashtra ,India Mumbai MAHARASHTRA	9819095659 reebun@yahoo.com
DrVijay Ramanan	Jehangir Clinical Development Center , Pvt.Ltd.	Jehangir Clinical Development Center , Pvt.Ltd. Jehangir Hospital, 32 Sassoon road-411 001 Pune MAHARASHTRA	912067268804 912026059319 mvijayr@gmail.com
Dr Unmesh Takalkar	Kodlikeri Memorial Hospital,	Kodlikeri Memorial Hospital,8, Manjeetnagar, Opp. Akashwan, Jalna Road, Aurangabad-431005 Satellite Site: CIIGMA Institute of Medical Sciences Pvt. Ltd, 3, Raghuveer Nagar, Opp. SFS High School, Jalna Road, Aurangabad-431001 Aurangabad MAHARASHTRA	912402359406 912402359279 takalkar.unmesh@gmail.com
Dr Amish Vora	Max Super Specialty Hospital	Max Super Specialty Hospital (A Unit of Devki Devi Foundation) 2, Press Enclave Road, Saket- 110017 New Delhi DELHI	919217162828 amish.vora@maxhealthcare.com
Dr Krishna Kumar Rathnam	Meenakshi Mission Hospital & Research Center,	Meenakshi Mission Hospital & Research Center, Lake Area, Melur Road -625107 Madurai TAMIL NADU	09380417299 915422586353 kkrathnam@gmail.com
Dr Sharat Damodar	Narayana Hrudayalaya Hospitals	Haematology, Narayana Hrudayalaya Hospitals, 258/A, Bommansandra Industrial Area, Anekal Taluk- 560099 Bangalore KARNATAKA	919880437134 918027835208 drsharat_damodar@yahoo.co.in
Dr Ashish Mukhopadhyay	Netaji subash Cancer Research Institute	Netaji subash Cancer Research Institute 16 A Park Lane, Park Street- 700016 Kolkata WEST BENGAL	919830020196 913322295628 ncri.clinicaltrials@gmail.com
Dr Rakesh Suresh Neve	Noble Hospital Pvt. Ltd	153, Magarpatta City Road, Hadapsar, Pune-411013, Maharashtra, India Pune MAHARASHTRA	9881143140 rakesh.neve@gmail.com
Dr Dinesh Bhurani	Rajiv Gandhi Cancer Institute & Research Center	Second Floor, OPD Block, New Building Rajiv Gandhi Cancer Institute & Research Center Sector - 5, Rohini- 110085 New Delhi DELHI	919971500861 911127931342 dineshbhurani@yahoo.co.in
Dr Sreejith Nair	Regional Cancer centre	Regional Cancer centre, PO.BOX 2417,Medical College Campus- 695011 Thiruvananthapuram KERALA	919744134492 914712558130 sreejith.sg@gmail.com
Dr Sadanand Karandikar	Ruby Hall Clinic	Department of Oncology Ruby Hall Clinic, 40, Sassoon road-411001 Pune MAHARASHTRA	912025678199 skaran44@gmail.com
Dr Shashikant Apte	Sahyadri Speciality Hospital	Sahyadri Hospitals Limited, Sahyadri Speciality Hospital, 30 C, Erandwane, Karve Road- 411004India & Sahyadri Clinical Research & Development Center, A Unit of Sahyadri Hospitals Limited, 30 C, Erandwane, Karve Road-411004, India Pune MAHARASHTRA	912067213000 912025459117 shashikant.apte@gmail.com
Dr Mukul Goyal	Searoc Cancer Center	S.K.Soni Hospital, Sec-5, Vidhyadhar Nagar,Sikar Road 302013 Jaipur RAJASTHAN	911412700107 911412233337 drmukulgoyal@yahoo.in
Dr Shailesh Bondarde	Shatabdi Superspeciality Hospital	Department of Oncology Shatabdi Superspeciality Hospital Suyojit City Centre, Opp. Mahamarg Bus Stand Mumbai Naka- 422005 Nashik MAHARASHTRA	919822012427 912532591159 shaileshbondarde@yahoo.com
Dr Shyam Aggarwal	Sir Ganga Ram Hospital	Room No. 1219, Dept of Medical Oncology, Sir Ganga Ram Hospital, Old Rajinder Nagar, New Delhi DELHI	911142251219 drshyam_aggarwal@yahoo.com
Dr Cessil Ross	St. Johns Medical College Hospital	Department of Medicine (Haematology) St. Johns Medical College Hospital Sarjapur Road - 560034 Bangalore KARNATAKA	918022065353 cecilross@sify.com
Dr Navin Khattry	Tata Memorial Centre	Hemato-Lymphoid (Adult), Department of medical Oncology, Tata Memorial Centre, Advanced Centre for Treatment, Research and Education in Cancer, Kharghar, Navi Mumbai â€“ 410210, India. Mumbai MAHARASHTRA	912227405404 nkhattry@gmail.com
Dr S Subramanian	V S Hospital	#13,East Spurtank Road, Chetpet - 600031,India Chennai TAMIL NADU	914442001000 clinicalresearch.vsh@gmail.com

Details of Ethics Committee
Modification(s)

No of Ethics Committees= 34
Name of Committee	Approval Status
Central India Cancer Research Institute Ethics Committee (PI - Dr Ajay Mehta)	Approved
Ethics Committee - Netaji Subhash Chandra Bose Cancer Research Institute (PI - Dr. Asis Mukhopadhyay)	Approved
Ethics Committee Jaslok Hospital and Research Centre (Dr. Reetu Jain)	Approved
Ethics Committee Jehangir Clinical Development Centre Pvt. Ltd.(PI - Dr Vijay Ramanan)	Approved
Ethics Committee Kodlikeri Memorial Hospital (K.M.H) & CIIGMA Hospital (CH)(Dr. Unmesh Takalkar)	Approved
Ethics Committee on Clinical Trials - Indraprastha Apollo Hospitals-Dr. Harsh Dua	Approved
Ethics Committee, Apollo Hospitals International Ltd. (PI - Dr. S S V Prasad)	Approved
Ethics Committee, Poona Medical & Research Foundation (PI - Dr S M Karandikar)	Approved
Ethics Committee, Sahyadri Hospitals Limited (PI - Dr. Shashikant Apte)	Approved
Ethics Committee, Sir Ganga Ram Hospital (Dr. Shyam Aggarwal)	Approved
Ethics Committee,Apollo Hospital Enterprises Limited (PI - Dr. T Raja)	Approved
Ethics Committee-V S Hospital(Dr. Subramaniam)	Approved
Gujarat Cancer Research Institute and Gujarat Cancer Society Ethics Committee (PI - Dr Sandip Shah)	Approved
HCG- Central Ethics Committee(PI-Dr.K. Govind Babu)	Approved
HCG-Central Ethics Committee (Dr. Radheshyam Naik)	Approved
Human Ethics Committee, Regional Cancer Centre, (PI - Dr Shreejith Nair)	Approved
Institute Ethics Committee â€“ Fortis Escorts Hospital (Dr. Rajeev Gupta)	Approved
Institutional Ethic Committee,Chittaranjan National Cancer Institute (PI - Dr. K K Mukherjee)	Approved
Institutional Ethics Committee - Tata Memorial Centre (PI - Navin Khattry)	Approved
Institutional Ethics Committee -Max Super Specialty Hospital (Dr Amish Vora)	Approved
Institutional Ethics Committee Deenanath Mangeshkar Hospital & Research Centre (PI - Dr Chetan Deshmukh)	Approved
Institutional Ethics Committee(Dr. Uttam Kumar Nath)	Approved
Institutional Ethics Committee, Basavatarakam Indo American Cancer Hospital & Research Institute(Dr. Rajappa)	Approved
Institutional ethics Committee, Bhagwan Mahaveer Cancer Hospital & Research Centre (Dr. Naresh Somani)	Approved
Institutional Ethics Committee, Noble Hospital Pvt. Ltd (Dr. Rakesh Neve)	Approved
Institutional Review Board (Ethics Committee) Christian Medical College & Hospital (Dr Auro Viswabandya)	Approved
Institutional Review Board, Rajiv Gandhi Cancer Institute and Research Centre (PI - Dr. Dinesh Bhurani)	Approved
Manavata Clinical Research Institute, Ethics Committee (PI - Dr Rajnish Nagarkar)	Approved
Meenakshi Mission Hospital & Research Center Institutional Ethics Committee Dr. Krishna Kumar Rathnam)	Approved
Narayan Hrudayalaya Medical Ethics Committee Pvt. Ltd.(PI - Dr Sharat Damodar)	Approved
Research Independent Ethics Committee (Dr Tanveer Maksud)	Approved
SEAROC Ethics Committee (PI - Dr Mukul Goyal)	Approved
Shatabdi Hospital Ethics Committee (PI - Dr S Bondarde)	Approved
St. Johns Medical College & Hospital, Institutional Ethical Review Board (PI - Dr. Cecil Ross)	Approved

Regulatory Clearance Status from DCGI

Status

Approved/Obtained

Health Condition / Problems Studied
Modification(s)

Health Type	Condition
Patients	Advanced Stage Follicular Lymphoma, (1) ICD-10 Condition: C509\|\|Malignant neoplasm of breast of unspecified site,

Intervention / Comparator Agent

Type	Name	Details
Comparator Agent	Comparator: MabThera (Rituximab)	Dose: dosed at 375 mg/mÂ² 8 treatment cycles of GP2013-CVP administered every 21 days (+/- 3 days) i.e. approximately a 6 month period followed by 8 treatment cycles of GP2013 administered every 3 months (+/- 14 days)for a further 2 years.
Intervention	Experimental: GP2013(Rituximab biosimilar)	Dose: dosed at 375 mg/mÂ² 8 treatment cycles of GP2013-CVP administered every 21 days (+/- 3 days) i.e. approximately a 6 month period followed by 8 treatment cycles of GP2013 administered every 3 months (+/- 14 days)for a further 2 years.

Inclusion Criteria
Modification(s)

Age From	18.00 Year(s)
Age To	75.00 Year(s)
Gender	Both
Details	Key Inclusion Criteria: 1. Patient with previously untreated advanced stage, CD20-positive FL 2. Patient with ECOG performance status 0, 1 or 2. Other protocol-defined inclusion criteria will apply

ExclusionCriteria

Details

Key Exclusion Criteria:

1. Patient with Grade 3b (aggressive) FL or any histology other than FL grade 1, 2 or 3a

2. Patient who has previously received any prior therapy for lymphoma

3. Patient with evidence of any uncontrolled, active infection (viral, bacterial or fungal).

4. Patient with any malignancy within 5 years prior to date of randomization, with the exception of adequately treated in situ carcinoma of the cervix uteri, basal or squamous cell carcinoma or non-melanomatous skin cancer.

Other protocol-defined exclusion criteria will apply

Method of Generating Random Sequence

Computer generated randomization

Method of Concealment

Pharmacy-controlled Randomization

Blinding/Masking

Participant, Investigator and Outcome Assessor Blinded

Primary Outcome

Outcome	TimePoints
Overall response rate in patients with Follicular Lymphoma	Time Frame - 24 weeks

Secondary Outcome

Outcome	TimePoints
Percentage of patients with Adverse Events (AEs)	Time Frame - upto 2 years

Target Sample Size

Total Sample Size="618"
Sample Size from India="120"
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)
Modification(s)

13/06/2012

Date of Study Completion (India)

Applicable only for Completed/Terminated trials

Date of First Enrollment (Global)

02/12/2011

Date of Study Completion (Global)

Applicable only for Completed/Terminated trials

Estimated Duration of Trial

Years="3"
Months="0"
Days="0"

Recruitment Status of Trial (Global)
Modification(s)

Closed to Recruitment of Participants

Recruitment Status of Trial (India)

Closed to Recruitment of Participants

Publication Details
Modification(s)

Not Applicable

Individual Participant Data (IPD) Sharing Statement

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

Brief Summary
Modification(s)

The purpose of this clinical study is to demonstrate comparability between the biosimilar agent GP2013 and MabTheraÂ® (which in some countries also marketed under the name RituxanÂ®)

Note: The inadvertant/system error in tab "Recruitment Status of Trial" led to change in enrollment status on 24 Jan 2013. The error was corrected on 15 Feb 2013. The recruitment status is "Open to Recruitment".