| CTRI Number |
CTRI/2023/08/056146 [Registered on: 04/08/2023] Trial Registered Prospectively |
| Last Modified On: |
31/07/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Study that only studies information for overcoming barriers and successfully implementing a free-of-cost Blinatumomab (immunotherapy medicine given in treatment of relapsed Acute Lymphoblastic Leukemia) facilitation program in a Low and Middle-Income countries like India |
|
Scientific Title of Study
|
Implementing Novel Agents and Translating Innovation Globally: A Non- Therapeutic Project to Facilitate Implementation of Novel Therapeutic Agents in Low and Middle-Income Countries with the Blincyto Humanitarian Access Program |
| Trial Acronym |
INOVATING |
|
Secondary IDs if Any
|
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Gaurav Narula |
| Designation |
Professor Pediatric Oncology and Health Sciences |
| Affiliation |
Tata Memorial Hospital |
| Address |
Department of Medical Oncology-Pediatrics, 1111 HBB, Homi Bhabha Block, Tata Memorial Hospital. Dr. Ernest Borges Road. Parel.
Mumbai
MAHARASHTRA
400012
India |
| Phone |
02224176761 |
| Fax |
|
| Email |
drgauravnarula@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Gaurav Narula |
| Designation |
Professor Pediatric Oncology and Health Sciences |
| Affiliation |
Tata Memorial Hospital |
| Address |
Department of Medical Oncology-Pediatrics, 1111 HBB, Homi Bhabha Block, Tata Memorial Hospital. Dr. Ernest Borges Road. Parel.
MAHARASHTRA
400012
India |
| Phone |
02224176761 |
| Fax |
|
| Email |
drgauravnarula@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Gaurav Narula |
| Designation |
Professor Pediatric Oncology and Health Sciences |
| Affiliation |
Tata Memorial Hospital |
| Address |
Department of Medical Oncology-Pediatrics, 1111 HBB, Homi Bhabha Block, Tata Memorial Hospital. Dr. Ernest Borges Road. Parel.
MAHARASHTRA
400012
India |
| Phone |
02224176761 |
| Fax |
|
| Email |
drgauravnarula@gmail.com |
|
|
Source of Monetary or Material Support
|
| Tata Memorial Hospital. Department of Medical Oncology-Pediatrics, 1111 HBB, Homi Bhabha Block, Tata Memorial Hospital. Dr. Ernest Borges Road. Parel. Pin: 400012. Maharashtra. India |
|
|
Primary Sponsor
|
| Name |
Tata Memorial Centre |
| Address |
Dr. Ernest Borges Road. Parel. Pin: 400012. Maharashtra. India |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| St Jude Childrens Research Hospital |
262 Danny Thomas Place Memphis, Tennessee 38105-3678 Telephone: (901) 595-3300 |
|
|
Countries of Recruitment
|
India
Pakistan
Viet Nam |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Surg Cdr Gaurav Narula |
Tata Memorial Hospital |
Department of Medical Oncology-Pediatrics, 1111 HBB, Homi Bhabha Block, Tata Memorial Hospital. Dr. Ernest Borges Road. Parel.
Mumbai
MAHARASHTRA |
02224176761
drgauravnarula@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee-II, Institutional Review Board, 3rd floor, Main Building, Tata Memorial Hospital, Dr. Ernest Borges Road, Parel. Mumbai. Pin-400012 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthcare professionals involved in delivering Blinatumomab therapy to the patients at the hospital |
| Patients |
(1) ICD-10 Condition: Z511||Encounter for antineoplastic chemotherapy and immunotherapy, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Not applicable |
Not applicable |
| Comparator Agent |
Not applicable |
Not applicable |
|
|
Inclusion Criteria
|
| Age From |
0.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. All stakeholders (Healthcare Professionals involved in administration of Blinatumomab)
2. All the patients and their caregivers receiving Blinatumomab therapy |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1 The barriers & facilitators to blinatumomab implementation in LMIC, including pilot site infrastructure score, climate score & readiness score, & score of perceived intervention complexity
2 The implementation outcomes: feasibility, acceptability, appropriateness, fidelity
3 Relative importance and feasibility of discrete implementation strategies
4 Adequacy of training programs as defined by Training Material Feedback, Provider Specific Knowledge Assessment, and surrogate clinical measures |
The interviews will be conducted after start of the treatment as the Blinatumomab is ongoing through the Blincyto Humanitarian Access Program, administered to the pediatric patients at baseline and during the therapy, at the end of therapy and 6 months survival data will be collected. Data from care providers will be collected once after initiation of the study at baseline and after providing training at 3 months and after 1 year via web-based systems designed and maintained by St. Jude. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| None |
None |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="30"
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)
|
23/10/2023 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
17/11/2021 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="5"
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
|
Acute Lymphoblastic Leukemia (ALL) (type of blood cancer) is the most
common type of blood cancer. ALL patients that have a partially responding
disease or relapsed disease are treated with Blinatumomab (immunotherapy
medicine) in High Income Countries. It becomes challenging to use this drug in Low
Middle Income Country (LMIC) like India because of the limited resources.
Blincyto Humanitarian Access Program (BHAP) has been implemented for the
administration of Blinatumomab supplemented with a training program at Tata
Memorial Hospital, Mumbai in Pediatric Medical Oncology Department.
This proposed study is going to be conducted in all 3 sites of India and
Pakistan, wherever BHAP has been implemented. In this study, Blinatumamob team
will be interviewed at treating centre through a well-structured questionnaire.
An online training for the staff involved in Blinatumamob administration has
been provided for the administration of program.
Data will be collected centrally by St. Jude’s team. This study will evaluate the quality of the implementation
of the program and will be aimed at assessing resources and training at the
implementing site. It will provide us with more ways to adapt new therapies and
technologies and pave the pathway for more such therapies to be implemented in
LMICs. |