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CTRI Number  CTRI/2022/09/045751 [Registered on: 21/09/2022] Trial Registered Prospectively
Last Modified On: 19/09/2022
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Other 
Public Title of Study   This is a type of cancer found in elderly patients  
Scientific Title of Study   A prospective observational cohort study to evaluate the effectiveness and toxicities of standard regimen in elderly patients with De-Novo DLBCL. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
3856  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Hasmukh Jain 
Designation  Professor and Consultant 
Affiliation  Tata Memorial Centre 
Address  81, Main Building, Ground Floor, Adult Hematolymphoid Unit, Tata Memorial Hospital, Dr. E. Borges road, Parel Mumbai 400012

Mumbai
MAHARASHTRA
400012
India 
Phone  022241770007211  
Fax    
Email  dr.hkjain@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Hasmukh Jain 
Designation  Professor and Consultant 
Affiliation  Tata Memorial Centre 
Address  81, Main Building, Ground Floor, Adult Hematolymphoid Unit, Tata Memorial Hospital, Dr. E. Borges Road, Parel Mumbai 400012

Mumbai
MAHARASHTRA
400012
India 
Phone  022241770007211  
Fax    
Email  dr.hkjain@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Hasmukh Jain 
Designation  Professor and Consultant 
Affiliation  Tata Memorial Centre 
Address  81, Main Building, Ground Floor, Adult Hematolymphoid Unit, Tata Memorial Hospital, Dr. E. Borges road, Parel Mumbai 400012

Mumbai
MAHARASHTRA
400012
India 
Phone  022241770007211  
Fax    
Email  dr.hkjain@gmail.com  
 
Source of Monetary or Material Support  
No Funding Required 
 
Primary Sponsor  
Name  Investigator initiated trial 
Address  Tata Memorial Hospital, Dr E. Borges road, Parel, Mumbai 400012 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Hasmukh Jain  Tata Memorial Hospital  Room no. 81, Main Building, Ground Floor, Adult Hematolyphoid Unit, Department: Medical Oncology, Tata Memorable Hospital, Dr. E Borges road, Parel, Mumbai 400012
Mumbai
MAHARASHTRA 
2224177018

dr.hkjain@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C851||Unspecified B-cell lymphoma,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  None  None 
Comparator Agent  None  None 
 
Inclusion Criteria  
Age From  60.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details 
Inclusion Criteria
1. Newly diagnosed cases of Diffuse Large B cell Lymphoma
2. Age more than or equal to 60 years.
3. Patients who provide written informed consent 
 
ExclusionCriteria 
Details  1. None
The patients found to meet all inclusion criteria of the study will thereafter be administered the informed
consent process 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Proportion of participants achieving complete response and partial response in clinical trial eligible
and clinical trial ineligible cohort receiving RCHOP, will be measured.  
6 months 
 
Secondary Outcome  
Outcome  TimePoints 
Proportion of patients in the clinical trial eligible cohort.  after the enrollment 
Proportion of patients achieving complete and partial response in clinical trial ineligible and in
clinical trial eligible cohort receiving RCEOP regimen. 
after completion of treatment 
Comparison of grade III and grade IV toxicities in all treatment cohorts:  during the treatment 
Comparison of dose modifications in all the treatment cohorts  during the treatment 
Survival analysis will be calculated from the date of enrolment till the end of 1 year, data will be
censored in case the patient is lost to follow-up.
 
after completion of one year treatment 
 
Target Sample Size   Total Sample Size="288"
Sample Size from India="288" 
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   N/A 
Date of First Enrollment (India)   28/09/2022 
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="4"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   None 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

In

Introduction:

Elderly patients are defined as the population 60 years and above. The most common type of lymphoma seen in elderly patients is Diffuse Large B cell Lymphoma (DLBCL). Previous clinical trials have shown that 3 weekly 6 cycles of R CHOP is the standard of care. It has been seen that in clinical trials the inclusion and exclusion criteria is as such that it does not matches the real world population.  The elderly population usually presents at baseline with concurrent illness, deranged organ function, poor performance. The purpose of this study is to know the effectiveness of standard treatment in our day to day practice in our hospital setting.

Methods:

Study will be conducted at Tata Memorial Hospital, Adult Hematolymphoid Unit. Patient will be screened and enrolled in the study, after the informed consent process. We have made a composite eligibility criteria based on the previous clinical trials. After the enrollment all the participants will be matched with the eligibility criteria. This will give a clear picture about how many enrolled participants actually meet the stringent eligibility criteria of the previously conducted randomized controlled trials.  The participants will be divided into two cohorts based on whether they match the clinical trial eligibility criteria or not.

All the participants will be given the treatment as per physician’s discretion. A geriatric assessment will be done by the investigator to know the fitness of the participants. We will follow the response of the treatment and side effects experienced by all the participants.

At the end of the study we will compare the response rates (Complete and partial responses) associated with a standard treatment regimen for cohort of patients who do not meet eligibility criteria for contemporary clinical trials versus the cohort of patients who meet the eligibility criteria for contemporary clinical trials.

We will also record the toxicities and one year overall survival in both the cohorts.

 
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