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CTRI Number  CTRI/2017/07/009035 [Registered on: 12/07/2017] Trial Registered Prospectively
Last Modified On: 05/12/2018
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Biosimilar ]  
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   A clinical trial to study the effects of two drugs SAIT101 and Rituximab for treatment in patients with low tumor of follicular lymphoma (cancer of the immune system)  
Scientific Title of Study   A Randomized, Double-blind, Multi-center, Multi-national Trial to Evaluate the Efficacy, Safety and Immunogencity of SAIT101 Versus Rituximab as a first-line immunotherapy Treatment in Patients with Low Tumor Burden Follicular Lymphoma  
Secondary IDs if Any  
Secondary ID  Identifier 
AGB 002 Protocol Version 1 Dated 7 Oct 2016  Protocol Number 
 
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  Suneela Thatte 
Designation  VP Global Operations  
Affiliation  IQVIA RDS (India) Private Limited 
Address  IQVIA RDS (India) Private Limited, Natraj by Rustomjee 6th floor 194 MV road Near Western Express Highway Metro Station Andheri East

Mumbai
MAHARASHTRA
400069
India 
Phone  912266774242  
Fax  912266774343  
Email  suneela.thatte@quintiles.com  
 
Details of Contact Person
Public Query

Modification(s)  
Name  Suneela Thatte 
Designation  VP- Global Operations  
Affiliation  IQVIA RDS (India) Private Limited 
Address  IQVIA RDS (India) Private Limited, Natraj by Rustomjee 6th floor 194 MV road Near Western Express Highway Metro Station Andheri East

Mumbai
MAHARASHTRA
400069
India 
Phone  912266774242  
Fax  912266774343  
Email  suneela.thatte@quintiles.com  
 
Source of Monetary or Material Support  
Archigen Biotech Limited 1 Francis Crick Avenue, Cambridge Biomedical Campus Cambridge CB2 0AA  
 
Primary Sponsor  
Name  Archigen Biotech Limited  
Address  Archigen Biotech Limited 1 Francis Crick Avenue Cambridge Biomedical Campus, Cambridge CB2 0AA, United Kingdom  
Type of Sponsor  Pharmaceutical industry-Global 
 
Details of Secondary Sponsor  
Name  Address 
Quintiles Research India Private Limited  B 101-106, Shapath IV, Opp Karnavati Club- Sarkhej Ghandi Nagar Road Ahmedabad 380051, India  
 
Countries of Recruitment     Australia
Belarus
Bosnia and Herzegovina
Brazil
Bulgaria
Chile
Croatia
Czech Republic
Democratic People's Republic of Korea
Egypt
France
Georgia
Germany
Guatemala
Hong Kong
Hungary
India
Italy
Latvia
Mexico
Panama
Philippines
Romania
Saudi Arabia
Serbia
South Africa
Spain
Thailand
Turkey
Ukraine
United Kingdom
United States of America  
Sites of Study
Modification(s)  
No of Sites = 22  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Singhal Mukesh Kumar   Acharya Tulsi Regional Cancer Treatment and Research Institute   Associated group of Hospitals S.P Medical College Bikaner 334003
Bikaner
RAJASTHAN 
051512226329

drmukeshsighal78@gmail.com 
Dr Sandip Bartakke  Aditya Birla Memorial Hospital  Department name: Clinical Hematology Floor: Ground floor Aditya Birla Memorial Hospital, Aditya Birla Marg, Morya Mangal Karyalay, Thergaon Chinchwad, Pune -411033, Maharashtra,India
Pune
MAHARASHTRA 
9763164057

spbartakke@rediffmail.com 
Kaushal Kumar Babubhai Patel  Apple Hospital  Udhna Darwaja, Ring Road, Surat- 395002, Gujarat, India
Surat
GUJARAT 
912616696000

drkaushalbpatel@gmail.com 
Dr Arun Warrier   Aster Medcity  Aster Medcity Aster DM Healthcare. LTD Kuttisahib road Near Kothad Bridge, South Chittoor P.O Cheranelloor- Kochi 682027, Kerala, India
Kollam
KERALA 
9400515000

drarun.warrier@dmhealthcare.com 
Dr Kalyan Kusum Mukherjee   Chittaranjan National Cancer Institute   37, S.P. Mukherjee Road. Kolkata-700026
Kolkata
WEST BENGAL 
9830115905

kkmukherjee4u@hotmail.com 
DrRajnish Nagarkar   Curie Manavata  Curie Manavata Cancer Centre Opp. Mahamarg Bus Stand, Mumbai Naka, Nashik - 422004, Maharashtra, India.
Nashik
MAHARASHTRA 
9823061929

drraj@manavatacancercentre.com 
Dr Chetan Dilip Deshmukh   Deenanath Mangeshkar Hospital and Research Centre  Deenanath Mangeshkar Hospital and Research Centre, Near Mhatre Bridge, Erandawne Pune – 411004, Maharashtra, India
Pune
MAHARASHTRA 
912024735465

drchetandeshmukh@gmail.com 
Dr Abdul Majeed   Department of General Medicine Government Medical College Kozhikode   Department of General Medicine Government Medical College Kozhikode Kerala, 673008 India
Kozhikode
KERALA 
9447311247

majeedonco@gmail.com 
Sadanand Madhav Karandikar  Grant Medical Foundation Ruby Hall Clinic   40, Sassoon Road, Pune- 411001, Maharashtra, India
Pune
MAHARASHTRA 
919809281963

skaran44@gmail.com 
DrBadarkhe Girish Vishwanat H   Health Care Global Enterprises   Health Care Global Enterprises Limited, #8, HCG Tower, (Tower 1, 2nd floor) P. Kalinga Rao Road, Sampangi Ram Nagar, Bangalore - 560027
Bangalore
KARNATAKA 
919902993531

drgirishvb@yahoo.co.in 
Dr Guru Prasad Mohanty   Kailash Cancer Hospital   Kailash Cancer Hospital and Research Centre, Muni Seva Ashram,Goraj- 391760, Waghodia, Vadodara, Gujarat, India
Vadodara
GUJARAT 
9427432383

guru.prasad@greenashram.org 
Dr Sandeep Goyle   Kokilaben  Kokilaben Dhirubhai Ambani Hospital and Medical Research Institute, Four Bungalows, Andheri (W), Mumbai - 400053, Maharashtra, India.
Mumbai
MAHARASHTRA 
919322527910

sandeep.goyle@relianceada.com 
Dr Santhosh Kumar Devadas   M.S Ramaiah Medical College and Hospital  M.S Ramaiah Medical College and Hospital, MSR Nagar, MSR IT Post, Bangalore –560054, Karnataka, India
Bangalore
KARNATAKA 
9980446774

drsanthoshkumar28@gmail.com 
Dr Mallikarjun Kalashetty  Manipal Hospital  Department name: Oncology Floor: Ground floor, Manipal Hospital ,98, HAL Airport Road, Bangalore -560017
Bangalore
KARNATAKA 
08025024632
080-25207181
mkalashetty@gmail.com 
Dr Sameer Khatri   Max Super Speciality Hospital  Max Super Speciality Hospital, Vaishali (A unit of Crosslay Remedies Limited) W-3, Sector -1, Vaishali, Ghaziabad – 201012, India
West
DELHI 
9810381883

drsamkhatri@rediffmail.com 
DrR Rang Rao   Max Super Speciality Hospital   FC 50, C & D Block, Shalimar Bagh, New Delhi -110088
Central
DELHI 
919810297787

Ranga.rao@maxhealthcare.com 
Dr Sharat Damodar   Mazumdar Shaw  Mazumdar Shaw Medical Center, Unit of Narayana Health, Narayana Hrudayalaya Limited, NH Health City No. 258/A Bommasandra Industrial Area, Anekal Taluk Bangalore 560099 Karnataka, India
Bangalore
KARNATAKA 
9880437134

drsharat.damodar@gmail.com 
Dr Rajib De   Nil Ratan Sircar Medical College & Hospital   Nil Ratan Sircar Medical College & Hospital 138, AJC Bose Road, Kolkata 700014, West Bengal, India
Kolkata
WEST BENGAL 
9433196143

rajibdrde@gmail.com 
Dr Muzzamil Shaikh   P.D. Hinduja National Hospital   P.D. Hinduja National Hospital and MRC Veersavarkar Marg, Mahim (W), Mumbai - 400016, Maharashtra, India
Mumbai
MAHARASHTRA 
24451515

dr_muzammil.shaikh@hindujahospital.com 
Dr Kannan Subramanian  Sahyadri Specialty Hospital   Dept: Hematology Sahyadri Specialty Hospital, 30C, Erandwane, Karve road, Pune 411004
Pune
MAHARASHTRA 
020-67213000

doc.kannan@gmail.com 
Dr Arora Rajendrasi Sujansignh  Sujan Surgical  Sujan Surgical Cancer Hospital And Amravati Cancer Foundation 52/B , Shankar Nagar , Main Road Amravati,444606.Maharastra ,India
Amravati
MAHARASHTRA 
917212578568

rsaroradr@gmail.com 
Dr Vivek Radhakrishnan  Tata Medical Center  Clinical Hematology First floor Tata Medical Center, 14 MAR (E-W), New Town, Rajarhat, Kolkata- 700156, West Bengal, India
Kolkata
WEST BENGAL 
9731130444

drvivekradhakrishnan@yahoo.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 24  
Name of Committee  Approval Status 
Amravati Ethics Committee  Approved 
Apple Hospital Ethics Committee  Approved 
Aster Medcity, Aster DM Heathcare Institutional Ethics Committee   Submittted/Under Review 
Ethics committee Aditya Birla Memorial hospital  Approved 
Ethics committee of Manipal Hospitals  Approved 
HCG Central Ethics Committee Health Care Global Enterprises Limited   Approved 
Institutional Ethics Committee Chittaranjan National Cancer Institute   Submittted/Under Review 
Institutional Ethics Committee Ethics Committee M.S Ramaiah Medical College and Hospitals  Approved 
Institutional Ethics Committee Lata Mangeshkar Medical Foundation’s   Approved 
Institutional Ethics Committee Max Super Speciality Hospital Vaishali   Approved 
Institutional Ethics Committee, Ester Medcity, Kochi  Approved 
Institutional Ethics Committee, Fortis Hospital, Ludhiana  Approved 
Institutional Ethics Committee, N.R.S Medical College & Hospital  Submittted/Under Review 
Institutional Scientific and Ethics Board Kokilaben Dhirubhai Ambani Hospital and Medical Research Institute   Approved 
Kailash Cancer and Medical Centre Instituional Ethics Committee   Approved 
Manayata Clinical Research Institute Ethics Committee  Approved 
Max Healthcare Ethics Committee  Approved 
Medical College Kozhikode, Institutional Ethics Committee  Approved 
Narayana Health Medical Ethics Committee   Submittted/Under Review 
P.D Hinuja National Hospital and MRC Instituional Ethics Committee  Submittted/Under Review 
Poona Medical Research Foundation Institutional Ethics Committee  Approved 
S.P Medical College & AG Hospitals Institutional Ethics committee   Submittted/Under Review 
Sahyadri Hospital Ltd Ethics Committee  Approved 
Tata Medical Center Institutional Review Board   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied
Modification(s)  
Health Type  Condition 
Patients  C829||Follicular lymphoma, unspecified, Low Tumor Burden Follicular Lymphoma ,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  MabThera®  375 mg/m2 (dose) i.v infusion Once a week for 4 weeks  
Intervention  SAIT101  375 mg/m2 (dose) i.v infusion Once a week for 4 weeks 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  1. Male or female patients aged at least 18 years.
2. Histologically-confirmed, without B symptoms, Ann Arbor stage II to IVA NHL (CD20 FL of Grades 1, 2, or 3a) (Appendix 5):
- Patients can be entered based on a diagnosis of CD20 follicular lymphoma confirmed at the investigational site. Archival tissue or slides must be sent to the central pathology reviewer for retrospective confirmation of diagnosis. Patients must have tissue or slide available for the central pathology review to be enrolled.
- Patients having both diffuse and follicular architectural elements will be considered eligible if the histology is predominantly follicular (i.e. greater than 50 percent –sectional area), and there is no evidence of transformation to a large cell histology.
- If the interval since tissue diagnosis of follicular lymphoma is more than 12 months, diagnostic confirmation using either core needle or excisional lymph node biopsy (latter preferred) is required to confirm that the histology remains in one of the eligible categories.
Bone marrow biopsy alone is not acceptable.
3. Low tumor burden according to GELF criteria defined as:
a) Normal serum lactate dehydrogenase (LDH) or beta2-microglobulin levels.
b) No mass 7 cm.
c) Less than 3 masses greater than 3 cm.
d) No systemic or B symptoms (fever greater than 38°C for 3 consecutive days; recurrent, drenching night sweats; unintentional weight loss exceeding 10 percent body weight in the last 6 months.
e) No splenomegaly greater than 16 cm by CT scan.
f) No risk of vital organ compression.
g) No pleural or peritoneal serous effusion.
h) No cytopenias (defined as platelets less than 100x109 L (100,000 mm3), hemoglobin less than 100g/L (10 g/dL), or absolute neutrophil count less than 1.5x109/L (1,500/mm3)).
4. Patients not previously treated for their FL, including any previous treatment for FL under clinical trials except localized radiation therapy for previous limited stage disease.
5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
6. Have at least one measurable lesion as per the IWG criteria 2007 at screening (lesion clearly measurable in at least 2 perpendicular dimensions).
7. Adequate renal function: Creatinine clearance 0.835 mL/s (50 mL/min) (Cockroft-Gault formula)
8. Adequate liver function: total bilirubin less than 34 μmol/L (2.0 mg/dL) except for patients with Gilbert’s Syndrome or hemolysis. Aspartate aminotransferase (AST) and alanineaminotransferase (ALT) less than 3 × upper limit of normal (ULN) (less than5 × ULN is acceptable if abnormalities are thought to be related to hepatic infiltration by FL).
- Patients with total bilirubin greater than 34 μmol/L (2.0 mg/dL) possibly due to Gilbert’s Syndrome should have a direct bilirubin checked. If the direct bilirubin is normal and medical history is suggestive/positive for Gilbert’s Syndrome, the patient successfully meets the criteria.
9. Men and women of childbearing potential must use 2 forms of accepted and highly effective methods of contraception during the course of the treatment period and for at least 12 months after the last infusion of study drug. A man or woman is of childbearing potential if, in the opinion of the investigator, he or she is biologically capable of having children and is sexually active. Examples of highly effective contraception include: combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation 1:
Oral
Intravaginal
Transdermal
•progestogen-only hormonal contraception associated with inhibition of ovulation 1:
oral
injectable
implantable 2, intrauterine device (IUD) 2, Intrauterine hormone- releasing system IUS
Bilateral tubal occlusion 2, vasectomised partner 2,3, sexual abstinence 4
1. Hormonal contraception may be susceptible to interaction with the study drug, which may reduce the efficacy of the contraception method
2. Contraception methods that in the context of this guidance are considered to have low user dependency
3. Vasectomised partner is highly effective birth control method provided that partner is the sole sexual partner of the study participant and that the vasectomised partner has received medical assessment of the surgical success.
4. In the context of this guidance sexual abstinence is considered a highly effective method only if defined as refraining from heterosexual intercourse during the entire period of risk associated with the study treatments.The reliability of sexual abstinence needs to be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the subject.

10. Female patients of childbearing potential must have a negative serum pregnancy test at screening visit 1 and a negative urine pregnancy test at each applicable visit thereafter. Females will be considered to be of non-childbearing potential if they fulfill one of the following criteria at screening:
- Postmenopausal defined as amenorrheic for at least 12 months following cessation of all exogenous treatments
- Documentation of irreversible surgical sterilization by hysterectomy, bilateral oophorectomy, or bilateral salpingectomy, but not tubal ligation.

11. Able to provide written informed consent, which must be obtained prior to any
study-related procedures.
 
 
ExclusionCriteria 
Details  1.Previous treatment with any chemotherapy and/or rituximab or other monoclonal antibody.
2.Prior radiotherapy completed <28 days before study enrollment.
3.Anticipated need for concomitant administration of any other experimental drug, or a concomitant chemotherapy, anticancer hormonal therapy, radiotherapy, or immunotherapy during study participation.
4.Concomitant disease which requires continuous therapy with corticosteroids at doses equivalent to prednisolone >20 mg/day.
5.Leukemia or transformation to diffuse large B cell lymphoma secondary to previously untreated follicular lymphoma.
6.Prior or concomitant malignancies within 5 years prior to screening, with the exceptions of non-melanoma skin cancer, adequately treated carcinoma in situ of the cervix, adequately treated breast cancer in situ, and localized prostate cancer stage T1c, provided that the patient underwent curative treatment and remains relapse free.
7.Patients with a body surface area >3.0 m2.
8.Major surgery (excluding lymph node biopsy) within 28 days prior to randomization.
9.Primary or secondary immunodeficiency (history of, or currently active), including known history of human immunodeficiency virus (HIV) infection or positive test at screening.
10.Acute, severe infection (e.g., sepsis and opportunistic infections), or active, chronic or persistent infection that might worsen with immunosuppressive treatment (e.g., herpes zoster).
11.Positive serological test for hepatitis B surface antigen (HBsAg), hepatitis B core antibody (HBcAb) or hepatitis C serology.
-Patients with a negative HBsAg and positive HBcAb must have a hepatitis B virus (HBV) deoxyribonucleic acid (DNA) level <20 IU/mL (or 112 copies/mL) by polymerase chain reaction (PCR). These HBV patients must be willing to undergo PCR HBV DNA testing during treatment and may participate following consultation with a hepatitis expert regarding monitoring and use of HBV antiviral therapy, and provided they agree to receive treatment as indicated. An HBV re-test will be performed at each study visit from Week 5 onwards, and at the discretion of the Investigator.
-Patients with a positive test because of HBV vaccine may be included (i.e., anti-HBs+, anti-HBc ).
-Patients positive for hepatitis C virus (HCV) antibody are eligible only if PCR is negative for HCV ribonucleic acid (RNA).
12.Confirmed current active tuberculosis (TB). Patients with latent TB as determined by tuberculosis skin testing (e.g. Mantoux test) or interferon-gamma release assay (IGRA e.g. QuantiFERON-TB test) may be enrolled if such patients have written confirmation from their health care provider (e.g., Pulmonologist or Infection Specialist) of adequate prophylaxis before or within the screening period, and no evidence of tuberculosis on a chest X-ray performed within 3 months of Day 1 or chest CT.
13.central nervous system CNS or meningeal involvement, or cord compression by the lymphoma; history of CNS lymphoma. A brain scan CT or MRI should be conducted at screening ONLY if lesions are suspected on the brain, to exclude patients with brain localization of FL.
14. history of a severe allergic reaction or anaphylactic reaction to a biological agent or history of hypersensitivity to any component of the trial drug e.g hypersensitivity or allergy to murine products.
15. Patients who have significant cardiac disease, including but not limited to history congestive heart failure (new york heart association class III/IV unstable angina, or uncontrolled cardiac arrhythmia
16. Uncontrolled or severe hypertension, or verebrovascular disease.
17. Serious underlying medical conditions that per the investigators discretion could impair the ability of the patient to participate in the trial (including but not limited to ongoing active infection, severe immunosuppression, uncontrolled diabetes mellitus, gastric ulcers, or active autoimmune disease). 18. Any other co-existing medical or psychological condition(s) that will preclude participation in the study or compromise ability to give informed consent and/or comply with study procedures.
19. Treatment with any investigational medicinal product (IMP) within 4 weeks prior to initiation of 1st infusion of study drug, or treatment with a drug that has not received regulatory approval for any indication within 4 weeks or a minimum of 5 half-lives, whichever is longer, of the 1st infusion of study drug.
20. Receipt of a live/attenuated vaccine within 6 weeks prior to the screening visit.
21. Females who are pregnant, breastfeeding, or planning a pregnancy during the treatment period or within 12 months after the last infusion of study drug.
22. Patients who are investigational site staff members directly involved in the conduct of the trial, and their family members, site staff members otherwise supervised by the investigator, or patients who are Archigen employees directly involved in the conduct of the trial.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Centralized 
Blinding/Masking   Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare the efficacy of SAIT101 with rituximab licensed in the European Union (hereafter designated MabThera®) when administered as a first-line immunotherapy in patients with low tumor burden follicular lymphoma (LTBFL).

Overall Response Rate (ORR) (Complete Response [CR] + Partial Response [PR]) at Week 28, as defined by International Working Group (IWG) criteria 2007.
This will be assessed centrally.
 
Week 28  
 
Secondary Outcome  
Outcome  TimePoints 
-Complete Response (CR)
-Partial Response (PR)
- Stable Disease (SD)
-Progressive disease (PD) 
Week 12 and 28  
Overall response rate  Week 12 
Time to event (TTE), defined as the time from the date of randomization to the date when an event occurs   an event is disease progression, death due to any cause, or the start of
new treatment for FL, whichever comes first 
 
Target Sample Size   Total Sample Size="308"
Sample Size from India="50" 
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)   19/07/2017 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  18/01/2017 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="30" 
Recruitment Status of Trial (Global)   Open to Recruitment 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   None yet  
Brief Summary   This is a multi-center, randomized, double-blind, parallel-group study to evaluate the efficacy and to assess the safety of SAIT101 versus MabThera in asymptomatic patients with low tumor burden follicular lymphoma. This study will take place globally in order to randomize approximately 308 participants. Eligible participants will be randomized to receive either SAIT101 or MabThera as an IV infusion once a week for 4 weeks at a standard dose of 375 mg/m2 body surface area. Patients will be followed up for up to 52 weeks from the start of the first infusion, Efficacy will be assessed at Weeks 12 and 28.   
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