CTRI/2012/11/003129 [Registered on: 21/11/2012] Trial Registered Prospectively
Last Modified On:
31/10/2017
Post Graduate Thesis
No
Type of Trial
Interventional
Type of Study
Drug Biological
Study Design
Randomized, Parallel Group Trial
Public Title of Study
A clinical trial to study the effects of two Anti-CD20 monoclonal antibodies in combination with CHOP in patients with diffuse large B-cell Lymphoma.
Scientific Title of Study
A Randomised, Multi-centre, Double-blind, Parallel Group Study to Compare the Pharmacokinetics, Pharmacodynamics, Safety and Efficacy of Two Anti-CD20 Monoclonal Antibodies in Combination with CHOP in Patients with CD20-Positive Diffuse Large B-cell Lymphoma
Trial Acronym
Secondary IDs if Any
Secondary ID
Identifier
RI-01-002 (Version: 2, 16-Nov-2011)
Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Dr Alok Srivastava MD FRACP FRCPA FRCP
Designation
Head Department of Hematology
Affiliation
Christian Medical College
Address
Christian Medical College,
IdaScudder Road,
Vellore TAMIL NADU 632 004 India
Phone
0416-2282352
Fax
0416-2226449
Email
aloks@cmcvellore.ac.in
Details of Contact Person Scientific Query
Name
Dr RashnaCama MD
Designation
Associate Medical Director
Affiliation
Quintiles Research (India) Pvt. Ltd.
Address
Medical Sciences, Drug Development Asia,
301-A-1, Leela Business Park
M.V.Road, Andheri (East)
Mumbai
Mumbai MAHARASHTRA 400 059 India
Phone
022-66774287
Fax
022-66774343
Email
Rashna.Cama@quintiles.com
Details of Contact Person Public Query
Name
Devas Seth
Designation
Project Lead
Affiliation
Dr. Reddy’s Laboratories Ltd.
Address
Clinical Development Department,
Biologics Development Center,
Survey No.47, Bachupally Village,
Qutbullapur, R.R. District,
A.P.
Rangareddi ANDHRA PRADESH 500090 India
Phone
040-44644000
Fax
040-23041418
Email
devasseth@drreddys.com
Source of Monetary or Material Support
Dr. Reddy’s Laboratories Ltd.
Biologics Development Center,
Survey No.47, Bachupally Village,
Qutbullapur, R.R. District,
A.P. 500090, India
Tel: +91 40 44644000
Primary Sponsor
Name
Dr Reddys Laboratories Ltd
Address
Biologics Development Center,
Survey No.47, Bachupally Village,
Qutbullapur, R.R. District,
A.P. 500090, India
Tel: +91 40 44644000
Medical Oncology, Bharat Cancer Hospital & Research Institute, Nirali Memorial Radiation Centre, Managed by Shri Bharatimaya Memorial Foundation, Manav Daya Trust Complex, Surat Bardoli Road, Saroli - 395010, Surat Surat GUJARAT
Suyojit City Centre, Opp. Mahamarg Bus Stand,
Mumbai Naka,
Nashik – 422005 Nashik MAHARASHTRA
09822012427
shaileshbondarde1971@gmail.com
Dr Suresh Sudalaiandi
Sri Ramachandra Medical Centre
Medical Oncology, Ramachandra Innovis, A Division of Ramachandra Medical Centre, Sri Ramachandra University Campus, No. 1 Ramachandra Nagar Porur, Chennai - 600116 Chennai TAMIL NADU
09841217666
drsureshonco@gmail.com
Dr Rajendersingh Arora
Sujan Surgical Cancer Hospital & Amravati Cancer Foundation
Sujan Surgical Cancer Hospital & Amravati Cancer Foundation,
52/B, Shankar Nagar Main Road, Amravati 444606, Maharashtra, India
Amravati MAHARASHTRA
91-9823097573 91-721-2578568 rsaroradr@gmail.com
Dr Reena Nair
Tata Medical Centre
Tata Medical Centre
Room No. A1 29, First Floor
Kolkata, West Bengal 700156 India"
Kolkata WEST BENGAL
03366057212
reenanair@gmail.com
Dr Bhausaheb Bagal
Tata Memorial Hospital
Tata Memorial Hospital, Dr. ernest Borges Marg, Parel, Mumbai-400012 Mumbai MAHARASHTRA
022-24177000 91-22-27405153 bagalbp@gmail.com
Dr Hari Menon
Tata Memorial Hospital
Tata Memorial Hospital
Dr. E. Borges Marg
Mumbai, Maharashtra 400012 India Mumbai MAHARASHTRA
02224177210
vadakepat68@yahoo.co.in
Dr Subramanian Sundaram
V. S. Hospital
#13,East Spurtank Road,
Chetpet, Chennai – 600031
Tamil Nadu, India Chennai TAMIL NADU
Central Ethics Committee of HCG group of Hospitals
Approved
Central Ethics Committee of HCG group of Hospitals
Approved
Delhi State Cancer Institute Institutional Ethics Committee, Delhi State Cancer Institute
Approved
Ethical Review Board
Approved
Ethics Committee
Approved
Ethics Committee
Approved
Ethics Committee
Approved
Ethics Committee
Approved
Ethics Committee of Manipal Hospitals
Approved
Ethics Committee on Clinical Trials, Indraprashtha Apollo Hospitals
Approved
Human Research Ethics Committee
Approved
Institutional Ethical Review Board
Approved
Institutional Ethics Committee
Submittted/Under Review
Institutional Ethics Committee
Submittted/Under Review
Institutional Ethics Committee
Approved
Institutional Ethics Committee
Approved
Institutional Ethics Committee
Approved
Institutional Ethics Committee (Dr. RMMC-IEC)
Approved
Institutional Ethics Committee, Basavatarakam Indo-American Cancer Hospital & Research Institute
Approved
Institutional Ethics Committee, CMC Ludhiana
Approved
Institutional Review board, Christian Medical college,
Approved
Jehangir Clinical Development Centre Institutional Review Board
Approved
Lakeshore Ethics Committee
Approved
Manavata Clinical Research Institute
Approved
Narayana Hrudayalaya Medical Ethics Committee
Approved
Nightingale Ethics Committee
Approved
Shatabdi Hospital Ethics Committee
Approved
Regulatory Clearance Status from DCGI
Status
Approved/Obtained
Health Condition / Problems Studied
Health Type
Condition
Patients
Diffuse LargeB-cellLymphoma
,
Intervention / Comparator Agent
Type
Name
Details
Intervention
DRL-rituximab (Redituxâ„¢)(500 mg and 100 mg)
Dose: 375 mg/m2, Frequency duration: 6 cycles with CHOP (each cycle of 21 days duration), Route of Administration: Intravenous infusion
Comparator Agent
MabThera®(500 mg and 100 mg)
Dose: 375 mg/m2, Frequency duration: 6 cycles with CHOP (each cycle of 21 days duration), Route of Administration: Intravenous infusion
Inclusion Criteria
Age From
18.00 Year(s)
Age To
60.00 Year(s)
Gender
Both
Details
1. Adult male or female patients 18 to 60 years of age (both inclusive), with histologically confirmed CD20+ diffuse large B-cell lymphoma.
2. Eastern Cooperative Oncology Group (ECOG, also referred to as Zubrod) performance status of 0, 1, or 2
3. Stage II, III, or IV by the Ann Arborclassification (Cotswold modification)
4. Adequate liver and renal function
5. Ability to comply with all study requirements
6. Signed and dated informed consent
ExclusionCriteria
Details
1. Diffuse large B-cell lymphoma that is primary CNS, effusional, or intravascular according to the WHO, 2008 classification
2. Diffuse lymphoma for which CHOP is not adequate therapy
3. Bulky Disease
4. Any CNS involvement by lymphoma
5. Severe active infection
6. Pregnant or lactating women or women trying to become pregnant during the study
Method of Generating Random Sequence
Stratified randomization
Method of Concealment
Centralized
Blinding/Masking
Participant and Investigator Blinded
Primary Outcome
Outcome
TimePoints
To evaluate the PK equivalence of two anti CD-20 antibodies [DRL-rituximab(Reditux™)and MabThera®]
3 weeks
Secondary Outcome
Outcome
TimePoints
To assess the objective response rate (ORR) at 6 cycles as defined by Revised Response Criteria for Malignant Lymphoma (Cheson, 2007)
18 weeks
Target Sample Size
Total Sample Size="190" Sample Size from India="190" Final Enrollment numbers achieved (Total)= "0" Final Enrollment numbers achieved (India)="0"
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Brief Summary
This study is a multi-centre, double-blind, parallel group, randomised comparative study of the pharmacokinetics,pharmacodynamics, safety and efficacyofDRL-rituximab (Reditux™)and MabThera®.All study patients will also be administered cyclical combination chemotherapy (cyclophosphamide, doxorubicin, vincristine and prednisolone [CHOP]) which represents the standard of care for the disease condition.The disease condition will be monitored at standard intervals and patients requiring alternative therapy for any reason will be promptly removed from the study.