Health Condition 1: null- leukemia
Conditions
Interventions
Sponsors
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
| Measure | Time 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
| Measure | Time 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
AIIMS