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CTRI Number  CTRI/2024/03/064716 [Registered on: 22/03/2024] Trial Registered Prospectively
Last Modified On: 21/03/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A clinical trial to test the use of a drug called Romiplostim in children after stem cell transplantation for early platelet recovery  
Scientific Title of Study   Romiplostim in pediatric patients post hematopoietic stem cell transplantation for early platelet engraftment: An open label randomised controlled trial  
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. Sanjana S 
Designation  Senior Resident, DM Pediatric Oncology 
Affiliation  AIIMS, New Delhi  
Address  8th Floor, Pediatric Office, Division of Pediatric Oncology, Department of Pediatrics, Mother and Child Block, AIIMS, Ansari Nagar, New Delhi

New Delhi
DELHI
110065
India 
Phone  9884520971  
Fax    
Email  sanjanasarangarajan@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr.Aditya Kumar Gupta 
Designation  Associate Professor 
Affiliation  AIIMS, New Delhi  
Address  8th floor Pediatric Office, Division of Pediatric Oncology, Department of Pediatrics, Mother and Child Block, AIIMS, Ansari Nagar, New Delhi

New Delhi
DELHI
110029
India 
Phone  7838379837  
Fax    
Email  adivick@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr.Aditya Kumar Gupta 
Designation  Associate Professor 
Affiliation  AIIMS, New Delhi  
Address  8th Floor Pediatric Office, Division of Pediatric Oncology, Department of Pediatrics, Mother and Child Block, AIIMS, Ansari Nagar, New Delhi
DEPARTMENT OF PEDIATRICS
New Delhi
DELHI
110029
India 
Phone  07838379837  
Fax    
Email  adivick@gmail.com  
 
Source of Monetary or Material Support  
The study is not funded and is being done as a part of the DM Pediatric Oncology super speciality thesis of Dr Sanjana. The drug for the thesis will be supplied by a pharmaceutical company on a compassionate basis and they have no role in the design of the study and they will not be involved in conduct of the study, interpretation of the data and in the final publication .  
 
Primary Sponsor  
Name  NIL 
Address  Not applicable 
Type of Sponsor  Other [Not applicable] 
 
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 Sanjana S   All India Institute of Medical Sciences, New Delhi   Division of Pediatric Oncology, Department of Pediatrics, Mother and Child Block, AIIMS, Ansari Nagar, New Delhi
New Delhi
DELHI 		 9884520971

sanjanasarangarajan@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute Ethics Committee for Post Graduate Research, All India Institute of Medical Sciences, Ansari Nagar, New Delhi- 110029  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C81-C96||Malignant neoplasms of lymphoid, hematopoietic and related tissue,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Romiplostim  It is a thrombopoietin receptor agonist. Dose - 5 mcg/kg subcutaneously injected. Two doses on day +1 and +7 (day +5 and +12 for haploidentical ) of transplant. site of injection - left arm deltoid region  
Comparator Agent  standard of care. No additional drug shall be given to the control group.   no placebo shall be administered 
 
Inclusion Criteria  
Age From  1.00 Year(s)
Age To  18.00 Year(s)
Gender  Both 
Details  undergoing allogenic or autologous hematopoietic stem cell transplantation  
 
ExclusionCriteria 
Details  1. History of thrombotic events in the past
2. Received thrombopoietic agents in the past
3. non consenting guardian
4. Second transplant
5. Bone marrow not in remission at the transplant
6. Reduced-intensity conditioning transplant
7. Umbilical cord blood transplant 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To compare the number of days to platelet engraftment, in children aged between 1 and 18 years, post hematopoietic stem cell transplantation, between the control and intervention groups.

 		 Day of platelet engraftment
(expected between 12-18 days as per retrospective cohort)
 
 
Secondary Outcome  
Outcome  TimePoints 
To compare the following parameters between children aged 1 to 18 years requiring stem cell transplantation and controls-

Need for platelet transfusions
Platelet count at day +28
Depth of platelet nadir
Number of significant bleeding episodes
Rates of thrombotic events 		 Need for platelet transfusions till engraftment
thrombotic events clinical follow up till 3 months post last dose of drug
 
 
Target Sample Size   Total Sample Size="30"
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   Phase 3 
Date of First Enrollment (India)   01/04/2024 
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="2"
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  

•        After applying the eligibility criteria, written informed consent shall be taken from the parent/ legally appointed representative and assent shall be taken from the child. The eligible subjects then shall undergo randomization as described before.

 

Intervention: Those assigned to the intervention arm shall receive romiplostim at a dose of 5 μg/kg subcutaneously (at a 45o angle) at the outer lateral aspect of the deltoid region of the right arm, keeping full aseptic precautions by the principal investigator. This injection shall be administered on day +1 of transplant , and shall be repeated on day+8. For haploidentical HSCT , the first dose will be administered on day +5 and the second dose on +12.The drug shall be supplied by the manufacturing company, Zydus Lifesciences Ltd. and it shall be reconstituted and stored as per the manufacturer’s instructions. The manufacturing company will not play any part in the study design, data collection or data analysis. Along with the intervention drug, standard of care shall continue as per the unit protocol. This shall also include filgrastim injection, according to the unit protocol.

Control: Those assigned control arm shall receive the standard of care as per the unit protocol, including filgrastim as applicable. No placebo shall be administered. 

 

Monitoring: Serial complete blood counts (CBC) shall be performed in both the groups daily till attainment of the primary endpoint of the study- a platelet count of 20,000/mm3 or above for three consecutive days, with no transfusion requirements in the last three days, followed by every alternate day, till day +28. CBC measurement shall be performed by automated blood cell counter machine under the SMART Laboratory, AIIMS.  

 
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