| 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
|
|
|
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
|
|
|
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
|
|
|
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. |