| 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
|
|
|
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
|
|
|
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. |