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CTRI Number  CTRI/2025/11/096796 [Registered on: 03/11/2025] Trial Registered Prospectively
Last Modified On: 31/10/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Longitudinal study 
Study Design  Single Arm Study 
Public Title of Study   A study on determining utility of an internet based application used for dose adjustment in the chemotherapy medicines prescribed to the children diagnosed with acute lymphoblastic leukemia (a type of blood cancer). 
Scientific Title of Study   Web based mobile application for titrating maintenance therapy in children with acute lymphoblastic leukemia 
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 Chetan Dhamne 
Designation  Professor, Medical Oncology-Pediatrics 
Affiliation  Tata Memorial Hospital  
Address  HBB-1111, Department of Medical Oncology-Pediatric Division. Dr. Ernest Borges Road. Parel.

Mumbai
MAHARASHTRA
400012
India 
Phone  9004300356  
Fax    
Email  chetandhamne@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Chetan Dhamne 
Designation  Professor, Medical Oncology-Pediatrics 
Affiliation  Tata Memorial Hospital  
Address  HBB-1111, Department of Medical Oncology-Pediatric Division. Dr. Ernest Borges Road. Parel.

Mumbai
MAHARASHTRA
400012
India 
Phone  9004300356  
Fax    
Email  chetandhamne@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Shubham Kumar 
Designation  Senior Resident 
Affiliation  Tata Memorial Hospital 
Address  OPD-88, Ground Floor, Main Building, Tata Memorial Hospital Dr. Ernest Borges Road. Parel.

Mumbai
MAHARASHTRA
400012
India 
Phone  9582998549  
Fax    
Email  subhamkumarht@gmail.com  
 
Source of Monetary or Material Support  
Foundation S (My Child Matters Program) 46 avenue de la Grande Armée 75017 Paris, France 
 
Primary Sponsor  
Name  Dr. CHETAN DHAMNE 
Address  HBB-1111, Department of Medical Oncology-Pediatric Division. Dr. Ernest Borges Road. Parel. 
Type of Sponsor  Other [Self] 
 
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 CHETAN DHAMNE  Tata Memorial Hospital  Room no. 1111, Homi Bhabha Block, Department of Medical Oncology-Pediatrics, Tata Memorial Hospital Dr. Ernest Borges Road Parel Mumbai 400012
Mumbai
MAHARASHTRA 
9004300356

chetandhamne@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee-I, IEC Ofiice, Dr E Borges Marg, Parel East, Mumbai 400012  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C910||Acute lymphoblastic leukemia [ALL], (2) ICD-10 Condition: C81||Hodgkin lymphoma, (3) ICD-10 Condition: C85||Other specified and unspecified types of non-Hodgkin lymphoma,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
Comparator Agent  Nil  Nil 
 
Inclusion Criteria  
Age From  1.00 Year(s)
Age To  14.00 Year(s)
Gender  Both 
Details  1.All patients with acute lymphoblastic leukemia/Lymphoma less than 15 years of age at the time of registration.
2. A parent/caretaker who understands the basic functioning of internet and committed enough to follow dose adjustment as communicated.
3. Written informed consent according to institutional guidelines. 
 
ExclusionCriteria 
Details  Unwillingness to participate in the study 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To determine the feasibility of using a web-based application for monitoring maintenance therapy in
patients with newly diagnosed acute lymphoblastic leukemia/lymphoma. 
The web application will be introduced to the patients after initiation of the maintenance therapy. The inputs and outputs from users are expected at 15 days interval. 
 
Secondary Outcome  
Outcome  TimePoints 
To assess the Health Related- Quality Of Life (HR-QOL) in children on maintenance therapy  The web application will be introduced to the patients after initiation of the maintenance therapy. 
To assess compliance to maintenance therapy in children with acute lymphoblastic
leukemia/lymphoma. 
The web application will be introduced to the patients after initiation of the maintenance therapy. The inputs and outputs from users are expected at 15 days interval. 
To assess adherence of medications during maintenance therapy  The web application will be introduced to the patients after initiation of the maintenance therapy. The inputs and outputs from users are expected at 15 days interval. 
Explore impact of dose intensity of maintenance therapy  The web application will be introduced to the patients after initiation of the maintenance therapy. The inputs and outputs from users are expected at 15 days interval. 
To study the social impact of maintenance therapy on patient and families  The web application will be introduced to the patients after initiation of the maintenance therapy. The inputs and outputs from users are expected at 15 days interval. 
 
Target Sample Size   Total Sample Size="1000"
Sample Size from India="1000" 
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)   22/12/2025 
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="5"
Months="0"
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  
The treatment of Acute Lymphoblastic Leukemia (ALL) in children lasts for 2–2.5 years, which consists of an initial 6–7 months of intensive therapy consisting of injections and oral chemotherapy, followed by 2 years of a maintenance phase, which usually consists of oral chemotherapy in the form of daily administration of oral tablets. Most of the maintenance therapy is administered at home, allowing the child to return to normal life, including school and regular activities. Children have regular blood tests to monitor their blood counts and the effect of the medication. The chemotherapy doses are then adjusted based on these results to maintain appropriate blood counts. Our study explores the feasibility of using a web-based mobile application to review the blood tests done by the children at their home and subsequently guide the dosing of medication. We are also looking at the quality of life experienced by the children once the child goes back to their home and rejoins school. We are looking forward to enrolling about 1000 patients through our mobile application service, who would be included in our study. Through this study, we look forward to streamlining and standardising the phase of maintenance therapy in the treatment of acute leukemia and identifying factors responsible for the decrease in compliance and adherence to treatment, as well as the low quality of life experienced by the children and their parents once they return home.
 
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