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CTRI Number  CTRI/2025/05/086476 [Registered on: 07/05/2025] Trial Registered Prospectively
Last Modified On: 06/05/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Pilot study 
Study Design  Single Arm Study 
Public Title of Study   Palliative Care in blood cancers undergoing CAR-T Cell therapy : A pilot single-arm single-center prospective observational study 
Scientific Title of Study   Integration of specialist palliative care in relapsed/refractory hematologic malignancies undergoing Chimeric Antigen Receptor (CAR)-T cell therapy: A pilot single-arm single-center prospective observational study 
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 Jayita Deodhar 
Designation  Professor and Head of Department  
Affiliation  Tata Memorial Hospital  
Address  Department of Palliative medicine, Room No 75,Main building, Ground floor, Tata Memorial Hospital, Parel , Mumbai-400012

Mumbai
MAHARASHTRA
400012
India 
Phone  241770007148  
Fax    
Email  jukd2000@yahoo.co.uk  
 
Details of Contact Person
Scientific Query
 
Name  Dr Jayita Deodhar 
Designation  Professor and Head of Department  
Affiliation  Tata Memorial Hospital  
Address  Department of Palliative medicine, Room No 75,Main building, Ground floor, Tata Memorial Hospital, Parel , Mumbai-400012

Mumbai
MAHARASHTRA
400012
India 
Phone  241770007148  
Fax    
Email  jukd2000@yahoo.co.uk  
 
Details of Contact Person
Public Query
 
Name  Dr Priyanka Shete 
Designation  Post graduate 
Affiliation  Tata Memorial Hospital 
Address  Department of Palliative medicine, Room No-75, Main building, Ground floor, Tata Memorial Hospital Parel , Mumbai-400012

Mumbai
MAHARASHTRA
400012
India 
Phone  241770007148  
Fax    
Email  shetepriyanka2017@gmail.com  
 
Source of Monetary or Material Support  
Tata Memorial Hospital, Parel, Mumbai -400012  
 
Primary Sponsor  
Name  NIL 
Address  NIL 
Type of Sponsor  Other [NIL] 
 
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 Jayita Deodhar  Tata Memorial Hospital  Department of Palliative medicine, Room No 75,Main building, Ground floor, Tata Memorial Hospital, Parel , Mumbai-400012
Mumbai
MAHARASHTRA 
9892358023

jukd2000@yahoo.co.uk 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE-1  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C969||Malignant neoplasm of lymphoid, hematopoietic and related tissue, unspecified, (2) ICD-10 Condition: C81-C96||Malignant neoplasms of lymphoid, hematopoietic and related tissue,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
Comparator Agent  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  Adult patients of age more than and equal to 18 years
Relapsed or Refractory hematologic malignancies Patients planned for CAR-T Cell Therapy
Patient has been informed of the diagnosis treatment and prognosis of disease
Able to communicate in English Marathi Hindi Bengali
Capable of giving a written informed consent
 
 
ExclusionCriteria 
Details  Patients planned for best supportive care alone
Patients should not have cognitive impairment preventing patients from comprehending questionnaire
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Feasibility of the study will be assessed by the proportion of patients who complete the questionnaire   Baseline (T0)
1 Day prior to initiating CAR-T cell therapy (T1)
Day 28 after CAR-T cell therapy (T2) 
 
Secondary Outcome  
Outcome  TimePoints 
1)Change in FACT-Leu & FACT-Lym score at T0,T1,T2
2)Symptom profile in this population using Edmonton Symptom Assessment System ESAS r CS at T0 T1 & T2
 
baseline (T0)
1 day prior to initiating CAR T cell therapy (T1)
Day 28 after CAR T Cell therapy (T2)
 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
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)   17/05/2025 
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="0"
Months="4"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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  

Blood cancers such as leukemia and lymphoma are aggressive and have high relapse rates, posing significant challenges for treatment. Chimeric Antigen Receptors (CAR)-T cell therapy, an innovative approach that modifies a patient’s T cells to target cancer cells, has shown promise for relapsed or refractory cases. However, patients undergoing CAR-T therapy often experience severe symptoms and reduced quality of life. Specialized palliative care ( SPC) can address these issues by providing holistic support to improve physical, psychological, and emotional well-being. This study aims to improve the quality of life for patients with relapsed or refractory blood cancers undergoing CAR- T Cell therapy. We will assess the feasibility and effectiveness of SPC into their treatment. SPC focuses on managing symptoms, pain, and stress to improve overall well-being. Our goal is to determine if SPC can enhance patients’ quality of life and reduce symptoms during CAR-T cell therapy. Patients will receive comprehensive care addressing physical, psychological, nursing, and social needs. It is a pilot single-arm single-center prospective observational study with duration of 4 months and study population includes adults aged more than 18 with relapsed / refractory blood cancers eligible for CAR-T therapy. We will assess quality of life and symptom burden at three time points: before CAR-T cell therapy, 1 day before initiating therapy, and 28 days after therapy. This study will provide valuable insights into improving care for blood cancer patients undergoing CAR-T cell therapy. Findings may advance future clinical practices and promote patient-centered care.

 
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