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CTRI Number  CTRI/2025/10/095779 [Registered on: 09/10/2025] Trial Registered Prospectively
Last Modified On: 27/09/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Non-randomized, Active Controlled Trial 
Public Title of Study   A Study Comparing Chemotherapy With and Without Venetoclax in Children and Young Adults With Acute Myeloid Leukemia 
Scientific Title of Study   Comparison of Outcome of Intensive Chemotherapy With and Without Venetoclax in Pediatric and Young Adult Acute Myeloid Leukemia Patients: A Non-Randomized Interventional Study 
Trial Acronym  VEN-INTENSE 
Secondary IDs if Any  
Secondary ID  Identifier 
Nil  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Nikhil Nagpal 
Designation  Senior Resident  
Affiliation  AIIMS Rishikesh  
Address  Department of Medical Oncology Hematology, AIIMS Rishikesh Uttarakhand

Dehradun
UTTARANCHAL
249203
India 
Phone  7030990959  
Fax    
Email  nikhilnagpal2011@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr. Uttam Kumar Nath 
Designation  Professor and Head of the Department 
Affiliation  AIIMS Rishikesh  
Address  Department of Medical Oncology Hematology AIIMS Rishikesh Uttarakhand

Dehradun
UTTARANCHAL
249203
India 
Phone  9433982756  
Fax    
Email  nath.uttam@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Nikhil Nagpal 
Designation  Senior Resident  
Affiliation  AIIMS Rishikesh  
Address  Department of Medical Oncology Hematology AIIMS Rishikesh Uttarakhand

Dehradun
UTTARANCHAL
249203
India 
Phone  7030990959  
Fax    
Email  nikhilnagpal2011@gmail.com  
 
Source of Monetary or Material Support  
AIIMS Rishikesh Uttarakhand India Pin 249203 
 
Primary Sponsor  
Name  Dr Nikhil Nagpal 
Address  Hostel 85, Room No. 414, AIIMS Rishikesh, Uttarakhand 
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 Nikhil Nagpal  AIIMS Rishikesh  In Patient Department of Pediatrics and Medical Oncology Hematology, Ward number 236 and 245
Dehradun
UTTARANCHAL 		 7030990959

nikhilnagpal2011@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C920||Acute myeloblastic leukemia,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Intensive Chemotherapy  intensive chemotherapy regimen (e.g., 3+7 induction or equivalent regimen) as per recommendation of standard guidelines. 
Intervention  Tablet Venetoclax along with Intensive chemotherapy   Tablet Venetoclax at a dose of 50-100 mg per oral once daily for 7 days along with intensive chemotherapy (e.g., 3+7 induction or equivalent regimen) as per recommendation of standard guidelines. 
 
Inclusion Criteria  
Age From  2.00 Year(s)
Age To  39.00 Year(s)
Gender  Both 
Details  1. Patients up to 39 years of age diagnosed with Acute Myeloid Leukemia (AML).
2.Patients eligible for intensive chemotherapy.
3.Written informed consent obtained from parents/guardians and assent from patients when appropriate.
 
 
ExclusionCriteria 
Details  1. Patients with contraindications to Venetoclax.
2. Acute Promyelocytic leukemia
3. Pregnant & Lactating mothers
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Post-induction flowcytometric measurable residual disease (Flow-MRD) response   18 months  
 
Secondary Outcome  
Outcome  TimePoints 
Post-induction morphological complete response (CR) rates   18 months  
Treatment-related adverse event profile   18 months 
 
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)   20/10/2025 
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="1"
Months="6"
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 - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report
    Response -  Analytic Code

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [nikhilnagpal2011@gmail.com].

  6. For how long will this data be available start date provided 11-09-2025 and end date provided 11-12-2027?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - Nil
Brief Summary  

This study aims to compare treatment outcomes in children and young adults with Acute Myeloid Leukemia (AML) receiving intensive chemotherapy with or without Venetoclax. The prospective group will receive Venetoclax in combination with standard intensive chemotherapy, while the historical control group received intensive chemotherapy alone. Outcomes will include post-induction measurable residual disease (MRD) response, complete remission rates, and treatment-related adverse events. The study will help determine whether adding Venetoclax improves remission rates and reduces residual disease. Findings may guide future treatment strategies for pediatric and young adult AML patients.

 
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