| CTRI Number |
CTRI/2018/03/012588 [Registered on: 15/03/2018] Trial Registered Prospectively |
| Last Modified On: |
18/11/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Biological |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Post marketing study to assess side effects, antibody development and effectiveness of Hetero-Rituximab |
|
Scientific Title of Study
|
A Phase IV Multi-Centric Post-Marketing Study Evaluating the Safety, Immunogenicity and EFFICACY of the Marketed Formulation of Hetero - Rituximab |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| HCR/IV/Ritux/01/2017 Version 1.1 dated 30 Aug 2017 |
Protocol Number |
|
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
|
| Designation |
|
| Affiliation |
|
| Address |
|
| Phone |
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| Fax |
|
| Email |
|
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Details of Contact Person
Scientific Query
|
| Name |
Dr Sreenivasa Chary S |
| Designation |
Deputy General Manager |
| Affiliation |
Hetero Drugs Limited |
| Address |
CDMA Department, 2nd Floor,
Hetero Corporate,
7-2-A2, Industrial Estates,
Sanath Nagar
Hyderabad
ANDHRA PRADESH
500018
India |
| Phone |
04023704923 |
| Fax |
04023801902 |
| Email |
sreenivasa.chary@heterodrugs.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr S D Sinha |
| Designation |
Senior Vice President |
| Affiliation |
Hetero Drugs Limited |
| Address |
CDMA Department, 2nd Floor,
Hetero Corporate,
7-2-A2, Industrial Estates,
Sanath Nagar
Hyderabad
ANDHRA PRADESH
500018
India |
| Phone |
04023704923 |
| Fax |
04023801902 |
| Email |
sd.sinha@heterodrugs.com |
|
|
Source of Monetary or Material Support
|
| Hetero Drugs Limited,
Hetero Corporate,
7-2-A2, Industrial Estates,
Sanath Nagar, Hyderabad - 18 |
|
|
Primary Sponsor
|
| Name |
Hetero Drugs Limited |
| Address |
Hetero Corporate, 7-2-A2, Industrial Estates, Sanath Nagar, Hyderabad - 18 |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
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Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 13 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Mallika Tiwari |
Banaras Hindu University Institute of Medical Sciences |
Department of Surgical oncology, Varanasi - 221005
Varanasi
UTTAR PRADESH |
09415600250
drmtewari@gmail.com |
| Dr MVT Krishna Mohan |
Basavatarakam Indo American Cancer Hospital & Research Institute |
Department of Medical oncology, Road no - 10, Banjarahills, Hyderabad -500034
Hyderabad
ANDHRA PRADESH |
09866154503
mvtkm@yahoo.com |
| Dr Shailesh Patel |
Bodyline hospital |
Department of Oncology, Opp Annapurna Hall, Nr. Dev status, New Vikas Gruh Road, Paldi
Ahmadabad
GUJARAT |
09825115060
bodylinehospitalcr@gmail.com |
| Dr Arun Seshachalam |
Dr. GVN Cancer Institute |
Department of medical Oncology, #46 Singhrapothe, Trichy-620008
Tiruchirappalli
TAMIL NADU |
09786220191
arunonco@gmail.com |
| Dr Premkumar Devdoss |
Govt. Stanley Medical College |
Department of Oncology, 305 OSH Road, Royapuram
Chennai
TAMIL NADU |
09952082727
drpremkumardevdoss@gmail.com |
| Dr Lalit Varadpande |
HCG Pinnacle Oncology Pvt. Ltd |
Department of Medical Oncology, Plot No,10,11,12 APIIC Health City, China Gadili, Arilova Mudasarlova Road Vishakhapatnam-530040
Visakhapatnam
ANDHRA PRADESH |
09848134176
lalit.v@hcgoncology.com |
| Dr Pramod Kumar Singh |
J.K. Cancer Institute |
Department of Radiotherapy & oncology, Rawtpur crossing, Kanpur-208005
Kanpur Nagar
UTTAR PRADESH |
09838200265
drpramodhsingh16@gmail.com |
| Dr Sonia Tiwari |
Jeevan Jyoti Multispeciality hospital |
Department of Oncology, 162 Bai Ka Bagh, Lowther Road
Allahabad
UTTAR PRADESH |
09450629141
drsonia.research@gmail.com |
| Dr Rakesh Reddy |
Mahatma Gandhi Cancer Hospital and Research Institute |
Department of Medical Oncology, 1/7 MVP Colony, Vishakhapatnam
Visakhapatnam
ANDHRA PRADESH |
09013355935
drrakeshreddyboya@yahoo.com |
| Dr P Radhika |
MNJ Institute of Oncology & Regional Cancer Center |
Department of Medical oncology, Red hills, Hyderabad -500004
Hyderabad
ANDHRA PRADESH |
09848792682
radhika.parimkayala@gmail.com |
| Dr Prabagar Manickam |
N.G. Hospital Pvt Ltd |
Department of Oncology, No 577, Trichy Road, Near B5 Police station, Singnallor, Coimbatore-641005
Coimbatore
TAMIL NADU |
09443681554
prabagardr@gmail.com |
| Dr Tushar Patil |
Noble Hospitals |
Department of Oncology, 153, Magapatta Road,Hadsapur Pune-411013
Pune
MAHARASHTRA |
09823133390
minishjain009@gmail.com |
| Dr Venkata Sushma |
St. Theresas Hospital |
Department of Oncology, Erragadda, Sananthnagar Hyderabad 500018
Hyderabad
ANDHRA PRADESH |
09701450182
sushmapv@yahoo.com |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 13 |
| Name of Committee |
Approval Status |
| Bodyline Ethics Committee, Bodyline hospital |
Submittted/Under Review |
| Ethics Committee Institute of Medical Sciences, Banaras Hindu University |
Submittted/Under Review |
| Ethics Committee J.K. Cancer Institute |
Submittted/Under Review |
| Ethics Committee Mahatma Gandhi Cancer Hospital and Research Institute |
Approved |
| Ethics Committee, HCG Pinnacle Oncology Pvt. Ltd |
Submittted/Under Review |
| Institutional Ethics Committee Govt. Stanley Medical College |
Submittted/Under Review |
| Institutional Ethics Committee Jeevan Jyoti Multispeciality hospital |
Approved |
| Institutional Ethics Committee N.G. Hospital Pvt Ltd |
Submittted/Under Review |
| Institutional Ethics Committee Noble Hospitals |
Submittted/Under Review |
| Institutional Ethics Committee, basvatarakam Indo-American Cancer Hospital & Research Institute |
Submittted/Under Review |
| Institutional Ethics Committee, Dr. GVN Cancer Institute |
Submittted/Under Review |
| Institutional Ethics Committee, St. Theresas Hospital |
Approved |
| MNJ Institute of Oncology & Regional Cancer Centre Ethics Committee |
Submittted/Under Review |
|
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Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C911||Chronic lymphocytic leukemia of B-cell type, (2) ICD-10 Condition: M317||Microscopic polyangiitis, (3) ICD-10 Condition: C859||Non-Hodgkin lymphoma, unspecified, Non-Hodgkins lymphoma, Chronic Lymphocytic Leukemia,
Rheumatoid Arthritis, Granulomatosis with polyangiitis
(Wegener’s granulomatosis) and Microscopic polyangiitis, (4) ICD-10 Condition: M069||Rheumatoid arthritis, unspecified, (5) ICD-10 Condition: M313||Wegeners granulomatosis, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Not applicable |
Not applicable |
| Intervention |
Rituximab: 100 mg/10 mL and 500 mg/50 mL solution in a single use
vial. |
Recommended Dose for Non-Hodgkins Lymphoma (NHL)is 375 mg/m2 as an intravenous infusion for 8 cycles
Recommended Dose for Chronic Lymphocytic Leukemia (CLL)is 375 mg/m2 the day prior to the initiation of FC chemotherapy, then 500
mg/m2 on Day 1 of cycles 2-6 (every 28 days)
Recommended Dose for Rheumatoid Arthritis (RA) is two-1000 mg intravenous infusions separated by 2 weeks
Recommended Dose for Granulomatosis with polyangiitis and microscopic polyangiitis (GPA &
MPA)is 375 mg/m2 body surface area, administered as an intravenous infusion
once weekly for 4 weeks (four infusions in total). |
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. The patient willing to give written, signed, and dated informed consent to participate in the study before initiating any study related procedures
2. Male and female adult patients, 18 years or older.
3. Patients with the following indications
o Patients with diagnosed Non-Hodgkin’s lymphoma
o Patients with diagnosed Chronic Lymphocytic Leukemia (CLL)
o Patients with diagnosed Rheumatoid arthritis
4. Any other patients indicated Rituximab as per physician’s discretion according to the prescribing information.
5. Adequate liver, renal, cardiac and haematological function as evidenced by:
o Transaminase (alanine transaminase [ALT]/aspartate transaminase [AST]) less than 2x upper limit of normal, or less than 5x upper limit of normal for patients with liver involvement
o Bilirubin <1.5 times ULN or total bilirubin ≤1.5 mg/dl, or total bilirubin ≤3 mg/dl for patients with Gilbert’s syndrome
o Absolute Neutrophil count ≥1500/mm
o Platelet count ≥100,000/mm
o Serum Creatinine less than 1.5x upper limit of normal
o Left ventricular ejection fraction (LVEF) ≥50% |
|
| ExclusionCriteria |
| Details |
1. Patients with clinical history/ evidence of allergy/hypersensitivity to murine proteins or components of Hetero-Rituximab.
2. An active, severe infection (e.g., tuberculosis, sepsis and opportunistic infections).
3. Major surgery within 4 weeks of study start
4. Need for emergency therapy such as neurologic compression syndrome
5. Receipt of live vaccine within 4 weeks prior to study drug administration
6. Current medical history/clinical evidence of hepatitis B or hepatitis C infection or HIV
7. Patients who are likely to be pregnant or lactating patients
8. Patients with history or pre-existing clinical evidence of medically significant abnormality or requirements for surgery that precludes the usage of Hetero-Rituximab, as per
investigator’s discretion |
|
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Method of Generating Random Sequence
|
Not Applicable |
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Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Incidence, severity, outcome, duration, action taken, and causality of individual adverse events [Expected and Unexpected adverse events (Serious and Non-serious Adverse Events)] reported during the study |
All visits |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Immunogenicity - development and change in antidrug antibodies (ADA) titer against Hetero – Rituximab |
Screening, 6-8 cycles and 12 months |
| Efficacy- Change in efficacy |
at end of 6-8 cycles |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
Final Enrollment numbers achieved (Total)= "200"
Final Enrollment numbers achieved (India)="200" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
19/03/2018 |
| Date of Study Completion (India) |
28/06/2019 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Not yet published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
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Brief Summary
|
This is an open-labeled, prospective, non-comparative, interventional postmarketing study in patients indicated and treated with marketing formulation of Hetero-Rituximab. The present study will gather the data of at least 200 patients. The primary objective is to evaluate the safety and tolerability of Rituximab under post marketing phase. The secondary objectives are to evaluate the immunogenicity and efficacy of Rituximab under post marketing phase. All patients will be monitored for significant clinical signs and symptoms and laboratory abnormalities during treatment. Immunogenicity will be evaluated by assessing serum for the presence of anti-rituximab antibodies in at least 100 indicated patients at screening, at the end of 6-8 cycles or the end of study, if happens earlier. Long term immunogenicity will be evaluated at the end of 12 months from baseline. At least 100 patients who undergo immunogenicity will also undergo efficacy assessments in according to the disease for which its indicated. |