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CTRI Number  CTRI/2012/10/003050 [Registered on: 09/10/2012] Trial Registered Retrospectively
Last Modified On: 04/11/2013
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   To compare the role of hydroxyurea (A medicine use in treatment) and conventional managment versus conventional managment alone to decrease cell count in children of acute leukemia (A type of blood cancer with increase in cell count more then 1 lakh/cmm. 
Scientific Title of Study   To compare the role of hydroxyurea and hyperhydration versus hyperhydration alone to decrease total leukocyte count in children of acute leukemia with hyperleukocytosis: a randomized control trial. 
Trial Acronym  NA 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Rachna Seth 
Designation  Associate Professor 
Affiliation  AIIMS 
Address  Department of Paediatrics, Room No: 3063, 3rd floor, Teaching Block. AIIMS,Ansari Nagar New Delhi-110029
Department of Paediatrics, Room No: 3058, 3rd floor, Teaching Block. AIIMS,Ansari Nagar New Delhi-110029
South
DELHI
110029
India 
Phone  9868397549  
Fax  -  
Email  drrachnaseth@yahoo.co.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Rachna Seth 
Designation  Associate Professor 
Affiliation  AIIMS 
Address  Department of Paediatrics, Room No: 3063, 3rd floor, Teaching Block. AIIMS,Ansari Nagar New Delhi-110029
Department of Paediatrics, Room No: 3058, 3rd floor, Teaching Block. AIIMS,Ansari Nagar New Delhi-110029
South
DELHI
110029
India 
Phone  9868397549  
Fax  -  
Email  drrachnaseth@yahoo.co.in  
 
Details of Contact Person
Public Query  
Name  Dr Rachna Seth 
Designation  Associate Professor 
Affiliation  AIIMS 
Address  Department of Paediatrics, Room No: 3063, 3rd floor, Teaching Block. AIIMS,Ansari Nagar New Delhi-110029
Department of Paediatrics, Room No: 3058, 3rd floor, Teaching Block. AIIMS,Ansari Nagar New Delhi-110029
South
DELHI
110029
India 
Phone  9868397549  
Fax  -  
Email  drrachnaseth@yahoo.co.in  
 
Source of Monetary or Material Support  
Indian Council of Medical Research grant for MD thesis. 
 
Primary Sponsor  
Name  No primary sponcer 
Address  NA 
Type of Sponsor  Other [It is a MD thesis, so there is no sponsor] 
 
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 Manish Sharma  Department of pediatrics AIIMS New Delhi  Department of pediatrics third floor, room 3058. AIIMS ansari nagar
South
DELHI 		 8447252379

manishsharmaaiims@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
AIIMS ethics committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  leukemia,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Conventional managment  Intavenous fluid dextrose normal saline 3 liter/meter square body surface area with 3 ml of sodium bicarbonate per 100 ml of fluid, and allopurinaol 
Intervention  Hydroxyuria and conventional managment  Hydroxyuria 75 mg/kg per oral in three divided doses for 72 hours  
 
Inclusion Criteria  
Age From  1.00 Year(s)
Age To  12.00 Year(s)
Gender  Both 
Details  • New case of acute leukemia with hyperleukocytosis
• Parent consent for trial
• Parent willing to take treatment for their child in our centre
 
 
ExclusionCriteria 
Details  • Refusal of consent
• Relapse of disease
• Age less then 1 year or more then 12 year
• Case treated outside
• Hyperleukocytosis associated with disease other than acute leukemia
• Hyperleukocytosis presented with acute renal failure, intracranial bleed and requiring ventilation
 
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To demonstrate that addition of hydroxyurea to conventional management causes a significant decline in TLC (fall in TLC 50% of baseline TLC in 72 hours) in a greater number of patients as compared to conventional therapy alone in newly diagnosed children (1-12 years) with acute leukemia and hyperleukocytosis.  72 hours 
 
Secondary Outcome  
Outcome  TimePoints 
1.To document reduction in complications associated with hyperleukocytosis with addition of hydroxyurea to conventional treatment.
• Tumor lysis
• Pulmonary complications
• CNS complications
• Hemorrhage
• Mortality
2. Rapidity of decline in TLC.
3. To determine the duration for initiating chemotherapy in children receiving hydroxyurea as comparedto conventional treatment alone.
4. To determine treatment failure after 72 of initiating therapy.
5. Adverse effect of hydroxyurea.
 		 72 hours 
 
Target Sample Size   Total Sample Size="48"
Sample Size from India="48" 
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" 
Phase of Trial   N/A 
Date of First Enrollment (India)   16/07/2012 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   Not published till now 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary   Trial is on basis of drug hydroxyuria which is used in many center for hyperleukocytosis & previous non randomized trial also shown efficacy. This trial will add in determining role of hydroxyuria in hyperleukocytosis. 
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