This is a type of cancer found in elderly patients

Not yet recruiting

Conditions: Unspecified B-cell lymphoma,

Registration Number: CTRI/2022/09/045751

Lead Sponsor: Investigator initiated trial

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 physicianâ€™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.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 288

Inclusion Criteria

Inclusion Criteria 1.
Newly diagnosed cases of Diffuse Large B cell Lymphoma 2.
Age more than or equal to 60 years.
Patients who provide written informed consent.

Exclusion Criteria

None The patients found to meet all inclusion criteria of the study will thereafter be administered the informed consent process.

Study & Design

Study Type: Observational

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Proportion of participants achieving complete response and partial response in clinical trial eligible	6 months
and clinical trial ineligible cohort receiving RCHOP, will be measured.	6 months

Secondary Outcome Measures

Name	Time	Method
Proportion of patients achieving complete and partial response in clinical trial ineligible and in	clinical trial eligible cohort receiving RCEOP regimen.
Comparison of dose modifications in all the treatment cohorts	during the treatment
Proportion of patients in the clinical trial eligible cohort.	after the enrollment
Comparison of grade III and grade IV toxicities in all 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.

Trial Locations

Locations (1): Tata Memorial Hospital
🇮🇳
Mumbai, MAHARASHTRA, India
Tata Memorial Hospital
🇮🇳Mumbai, MAHARASHTRA, India
Dr Hasmukh Jain
Principal investigator
2224177018
dr.hkjain@gmail.com