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.
Completed
- Conditions
- leukemia
- Registration Number
- CTRI/2012/10/003050
- Lead Sponsor
- No primary sponcer
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 48
Inclusion Criteria
•New case of acute leukemia with hyperleukocytosis •Parent consent for trial •Parent willing to take treatment for their child in our centre.
Exclusion Criteria
•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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Measures
Name Time Method 1.To document reduction in complications associated with hyperleukocytosis with addition of hydroxyurea to conventional treatment. •Tumor lysis
Trial Locations
- Locations (1)
Department of pediatrics AIIMS New Delhi
🇮🇳South, DELHI, India
Department of pediatrics AIIMS New Delhi🇮🇳South, DELHI, IndiaDr Manish SharmaPrincipal investigator8447252379manishsharmaaiims@gmail.com