| CTRI Number |
CTRI/2024/12/078777 [Registered on: 30/12/2024] Trial Registered Prospectively |
| Last Modified On: |
06/12/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Finding out the correlation between infusion-related reactions and blood parameters and demographic factors following the initial Rituximab chemotherapy drug infusion dose. |
|
Scientific Title of Study
|
Prevalence and correlation of infusion-related reactions with haematological and demographic factors following the first dose of Rituximab infusion |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Karthik S Udupa |
| Designation |
Professor and Head |
| Affiliation |
Manipal Acedemy of Higher Education |
| Address |
4th floor, No: 01, Department of Medical Oncology
Shiri Saibaba cancer hospital, near Tiger circle
Kasturba Medical College and Hospital, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9845317153 |
| Fax |
|
| Email |
udupa.karthik@manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Karthik S Udupa |
| Designation |
Professor and Head |
| Affiliation |
Manipal Acedemy of Higher Education |
| Address |
4th floor, No: 01, Department of Medical Oncology
Shiri Saibaba cancer hospital, near Tiger circle
Kasturba Medical College and Hospital, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9845317153 |
| Fax |
|
| Email |
udupa.karthik@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Karthik S Udupa |
| Designation |
Professor and Head |
| Affiliation |
Manipal Acedemy of Higher Education |
| Address |
4th floor, No: 01, Department of Medical Oncology
Shiri Saibaba cancer hospital, near Tiger circle
Kasturba Medical College and Hospital, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9845317153 |
| Fax |
|
| Email |
udupa.karthik@manipal.edu |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Manipal Acedemy of Higher Education |
| Address |
4th floor, No: 01, Department of Medical Oncology
Shiri Saibaba cancer hospital, near Tiger circle
Kasturba Medical College and Hospital, Manipal - 576104, Karnataka, India
|
| 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 Ananth Pai |
Kasturba Medical College and Hospital , Manipal |
4th floor, No: 03, Department of Medical Oncology
Shiri Saibaba cancer Hospital, near Tiger circle
Kasturba Medical College and Hospital
Udupi
KARNATAKA |
9880239139
ananth.pai@manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| KasturbaMedicalcollegeandKasturbahospitalInstitutionalEthicsCommittee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C819||Hodgkin lymphoma, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
Patients of any malignancy receiving rituximab-based chemotherapy |
|
| ExclusionCriteria |
| Details |
Benign conditions
Non hematological malignancies
Prior Rituximab administration
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Prevalence and types of infusion-related reactions following the first dose of rituximab. |
one time point |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Correlation of infusion-related reactions with total leucocyte counts, other hematological parameters, demographic factors and tumor-related factors |
one time point |
|
|
Target Sample Size
|
Total Sample Size="68"
Sample Size from India="68"
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)
|
05/02/2025 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
After obtaining IEC clearance., we will register under CTRI, once
we receive the approval from CTRI the study will be started by including all adult patients (≥18 years) treated in KMC Manipal with the
first dose of Rituximab for any indication will be enrolled. Patient’s demographic factors
like age, sex, performance status, comorbidity status, body surface -area, and
body mass index; hematological parameters like- white blood cell count,
absolute lymphocyte count, absolute neutrophil count, LDH, and hemoglobin;
tumor-related factors like -type, grade, stage of lymphoma, B-symptoms, IPI,
bulky disease (> 10 cm ), bone marrow
involvement, number of Extranodal sites, and LDH levels. Treatment-related
factors like the type of chemotherapy, type of infusion-related reaction,
defined as any adverse event occurring during or within 24 hours of rituximab
infusion, time of onset of reaction, type of intervention, CTCAE grading, and consequences post-intervention, will be recorded. |