At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 1 enrolled
Drug / intervention
Daunorubicindrug
Likely dose
Daunorubicin 6.75mg/m2from record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Pilot Study of Targeted Daunorubicin Dosing to Overcome Chemotherapeutic Resistance in Children With Relapsed or Refractory Acute Leukemia
In Brief
A Phase 2 clinical trial evaluating Daunorubicin for Relapsed Pediatric ALL and 3 related conditions. Completed, enrolled 1 participant across 1 site.
Detailed Summary
In this pilot study, eligible pediatric patients will be treated with 5 consecutive days of low dose daunorubicin. All patients who receive low dose daunorubicin will be evaluated daily for potential toxicity during those 5 days. Once the patient has received 5 doses of daunorubicin, subsequent therapy will be at the discretion of the primary oncology team.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRelapsed Pediatric ALL, Relapsed Pediatric AML, Refractory Acute Myeloid Leukemia, Refractory Acute Lymphoblastic Leukemia
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
202120222023202420252026
Enrollment StartMay 2020
First PostedSep 2020
Primary CompletionJun 2022
TodayJul 2026
First PostedSep 24, 2020
Enrollment StartMay 8, 2020
Primary CompletionJun 30, 2022
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 5.8 years ago
Interventions
Daunorubicindrug
Eligible patients with relapsed and/or refractory acute leukemia will receive daunorubicin 6.75mg/m2 daily for 5 consecutive days.