An elaborative clinical study project for comparing hydroxyurea, a drug, usually used for reducing white blood cells(WBCs) and L-asparaginase, which can be used for reducing WBCs in increased WBCs, in Acute Myeloid Leukaemia, a type of blood cancer in pediatric patients with increased WBCs

A phase-3 randomized control trial comparing hydroxyurea and L-asparginase for cytoreduction in pediatric AML patients presenting with hyperleucocytosis

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2018/10/016194

Enrollment

Registered

2018-10-30

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: C929- Myeloid leukemia, unspecified

Interventions

Intervention1: L-asparaginase: L-asparaginase leads to well-controlled apoptosis without causing any breakage of the cell membrane and is likely to cause decreased incidence of tumor lysis. Moreover L

Eligibility

Inclusion criteria

Inclusion criteria: 1. Diagnosis: Acute Myeloid leukemia. 2. WBC count > 100,000/mm3 . 3. Newly diagnosed, previously untreated patients 4. Informed consent of patient / legal guardian

Exclusion criteria

Exclusion criteria: 1. APML patients 2. Clinical tumor lysis syndrome at the time of admission. 3. Hyperleucocytosis associated with significant bleeding, cerebral hemorrhage 4. Hyperleukocytosis associated with deranged clotting 4. Past history of thrombosis

Design outcomes

Primary

Measure	Time frame
To compare rate of cytoreduction of L-asparaginase versus HydroxyureaTimepoint: At baseline all basic characteristics like age, sex, WBC count, and biochemical parameters , coagulation profile will be recorded. Blood tests will be done to monitor WBC count and biochemical parameters till WBC count 50,000 or 120 hr after enrolment whichever is earlier. Patients will be monitored for complications and adverse effects of hydroxyurea and L-asparginase in the respective arms. Patients would be evaluated for apoptosis by flowcytometric analysis during the first 72hrs.	—

Measure

Time frame

To compare rate of cytoreduction of L-asparaginase versus HydroxyureaTimepoint: At baseline all basic characteristics like age, sex, WBC count, and biochemical parameters , coagulation profile will be recorded. Blood tests will be done to monitor WBC count and biochemical parameters till WBC count 50,000 or 120 hr after enrolment whichever is earlier. Patients will be monitored for complications and adverse effects of hydroxyurea and L-asparginase in the respective arms. Patients would be evaluated for apoptosis by flowcytometric analysis during the first 72hrs.

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Secondary

Measure	Time frame
1. To compare the incidence of tumor lysis syndrome, leucostasis, DIC between the treatment groups 2. To compare degree of apoptosis between the treatment groups 3. To compare early mortality (42 days from diagnosis) between the treatment groups 4. To assess the incidence of adverse events associated with L- Asparaginase and Hydroxyurea Timepoint: At baseline all basic characteristics like age, sex, WBC count, and biochemical parameters , coagulation profile will be recorded. Blood tests will be done to monitor WBC count and biochemical parameters till WBC count 50,000 or 120 hr after enrolment whichever is earlier. Patients will be monitored for complications and adverse effects of hydroxyurea and L-asparginase in the respective arms. Patients would be evaluated for apoptosis by flowcytometric analysis during the first 72hrs.	—

Measure

Time frame

1. To compare the incidence of tumor lysis syndrome, leucostasis, DIC between the treatment groups 2. To compare degree of apoptosis between the treatment groups 3. To compare early mortality (42 days from diagnosis) between the treatment groups 4. To assess the incidence of adverse events associated with L- Asparaginase and Hydroxyurea Timepoint: At baseline all basic characteristics like age, sex, WBC count, and biochemical parameters , coagulation profile will be recorded. Blood tests will be done to monitor WBC count and biochemical parameters till WBC count 50,000 or 120 hr after enrolment whichever is earlier. Patients will be monitored for complications and adverse effects of hydroxyurea and L-asparginase in the respective arms. Patients would be evaluated for apoptosis by flowcytometric analysis during the first 72hrs.

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Countries

India

Contacts

Public ContactDr Shripad Banavali

Tata Memorial Hospital

banavali_2000@yahoo.com912224177217

Outcome results

None listed

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