At a glance
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A Phase I Study of 5-Azacytidine in Combination With Chemotherapy for Children With Relapsed or Refractory ALL or AML
In Brief
A Phase 1 clinical trial evaluating Azacytidine, Fludarabine, and 3 other interventions for Lymphoblastic Leukemia, Acute, Childhood and Myelogenous Leukemia, Acute, Childhood. Completed, enrolled 15 participants across 23 sites in 3 countries.
Detailed Summary
This is a Phase I study with a conditional cohort expansion phase to evaluate the feasibility of, and to obtain preliminary efficacy data about, pretreatment with Azacytidine (AZA) for 5 days followed by fludarabine/cytarabine chemotherapy regimen in pediatric acute myeloid leukemia (AML) and acute lymphoblastic leukemia (ALL) patients who are refractory to primary treatment or who relapsed.
Study Details
Timeline
Interventions
Dose assigned at study entry (75 mg/m2/day). Given subcutaneously, once daily on days 1 to 5, for a total of 5 doses.
30 mg/m2/dose, intravenous infusion over 30 minutes, once daily, on days 6 to 10, total 5 doses
2000 mg/m2/dose intravenous infusion over 3 hours, starting 4 hours after the beginning of fludarabine, once daily, on days 6 to 10, total 5 doses.
Intrathecally to AML patients on day 1 of course 1 and 2. * Omit on day 1 of course 1 if patient received IT therapy within 7 days prior to study enrollment * IT therapy may be given during the end of course 1 disease evaluation and repeated every 7 days * For patients with CNS disease, IT cytarabine can be given weekly until the CSF is clear. Two additional doses of IT cytarabine should be given weekly after the initial CSF clearing. It is permitted to change to intrathecal triple therapy (ITT) if persistent blasts are present in the CSF based on the treating physician's clinical judgment. Cytarabine dose defined by age: * 30 mg for patients age 1-1.99 * 50 mg for patients age 2-2.99 * 70 mg for patients \>3 years of age ITT Dosing: Age (yrs) - Dose Methotrexate (MTX), Hydrocortisone (HC), Cytarabine (ARAC): 1. \- 1.99 MTX: 8 mg, HC: 15 mg, ARAC: 30 mg 2. \- 2.99 MTX: 10 mg, HC: 25 mg, ARAC: 50 mg * 3 - MTX: 12 mg, HC: 35 mg, ARAC: 70 mg
* Intrathecally to patients with ALL on day 1 of course 1 and 2. * Omit IT MTX on Day 1 of course 1 if patient received IT therapy within 7 days prior to study enrollment * IT therapy may be given during the end of course 1 disease evaluation and repeated every 7 days * For patients with CNS 2 or 3 disease, IT MTX can be given weekly until the CSF is clear. Two additional doses of IT MTX should be given weekly after the initial clearing of the CSF. It is permitted to change to ITT if persistent blasts are present in the CSF. Methotrexate dose defined by age * 8 mg for patients age 1-1.99 * 10 mg for patients age 2-2.99 * 12 mg for patients 3-8.99 years of age * 15 mg for patients \>9 years of age Triple IT Therapy Dosing: Age (yrs): Dose Methotrexate (MTX), Hydrocortisone (HC), Cytarabine (ARAC): 1. \- 1.99 MTX: 8 mg, HC: 8 mg, ARAC: 16 mg 2. \- 2.99 MTX: 10 mg, HC: 10 mg, ARAC: 20 mg 3. \- 8.99 MTX: 12 mg, HC: 12 mg, ARAC: 24 mg * 9 MTX: 15 mg, HC: 15 mg, ARAC: 30 mg