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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.

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. - NA

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2012/10/003050
Enrollment
48
Registered
2012-10-09
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- leukemia

Interventions

Intervention1: Hydroxyuria and conventional managment: Hydroxyuria 75 mg/kg per oral in three divided doses for 72 hours Intervention2: Hyroxyuria: Hydroxyuria act on ribonucliotide diphosphate reduc

Sponsors

No primary sponcer
Lead Sponsor

Eligibility

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
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.Timepoint: 72 hours

Secondary

MeasureTime frame
1.To document reduction in complications associated with hyperleukocytosis with addition of hydroxyurea to conventional treatment. â?¢ Tumor lysis â?¢ Pulmonary complications â?¢ CNS complications â?¢ Hemorrhage â?¢ 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. Timepoint: 72 hours

Countries

India

Contacts

Public ContactDr Rachna Seth

AIIMS

drrachnaseth@yahoo.co.in9868397549

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026