Adults 1 to 21, any sex, with Relapsed Pediatric ALL or Relapsed Pediatric AML. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Incidence of Low Dose Daunorubicin Feasbility as Assessed by Absolute Blast CountPrimary· 24 months
Feasibility failure due to progressive leukemia is defined as a rise in absolute blast count (ABC) of \>10,000/day on two consecutive days that continues to increase \>10,000/day after starting hydroxyurea.
Group
Value
95% CI
Patients With Relapsed/Refractory ALL and AML
0
Patients With Relapsed/Refractory ALL and AML
1
Incidence of Low Dose Daunorubicin Feasbility as Assessed by Extramedullary Leukemia ProgressionPrimary· 24 months
Low dose daunorubicin will also be deemed not feasible if there is evidence of progression of extramedullary leukemia such progression of chloroma or leukemia cutis. or if the patient experiences uncontrollable nausea and/or vomiting.
Group
Value
95% CI
Patients With Relapsed/Refractory ALL and AML
0
Patients With Relapsed/Refractory ALL and AML
1
Incidence of Low Dose Daunorubicin Feasbility as Assessed by Patient SymptomsPrimary· 24 months
Low dose daunorubicin will also be deemed not feasible if the patient experiences uncontrollable nausea and/or vomiting.
Group
Value
95% CI
Patients With Relapsed/Refractory ALL and AML
0
Patients With Relapsed/Refractory ALL and AML
1
Pharmacokinetic Parameters of Low Dose Daunorubicin in Children With Relapsed/Refractory AML and ALL as Assessed by Maximum Concentration.Secondary· 24 months
Serial daunorubicin levels for evaluation of maximum concentration will be drawn prior to infusion and at 5, 20 and 40 minutes and at hours 1,2,4,8 and 24 post infusion.
Group
Value
95% CI
Patients With Relapsed/Refractory ALL and AML
18.7
Pharmacokinetic Parameters of Low Dose Daunorubicin in Children With Relapsed/Refractory AML and ALL as Assessed by Time at Maximum Concentration.Secondary· 24 months
Serial daunorubicin levels for evaluation of time at maximum concentration will be drawn prior to infusion and at 5, 20 and 40 minutes and hours 1,2,4,8 and 24 post infusion.
Group
Value
95% CI
Patients With Relapsed/Refractory ALL and AML
0.33333
Pharmacokinetic Parameters of Low Dose Daunorubicin in Children With Relapsed/Refractory AML and ALL as Assessed by Area Under the Curve.Secondary· 24 months
Serial daunorubicin levels for evaluation of exposure by measuring area under the curve will be drawn prior to infusion and at 5, 20 and 40 minutes and hours 1,2,4,8 and 24 post infusion.
Group
Value
95% CI
Patients With Relapsed/Refractory ALL and AML
20.889865
Pharmacokinetic Parameters of Low Dose Daunorubicin in Children With Relapsed/Refractory AML and ALL as Assessed by Elimination Half-lifeSecondary· 24 months
Serial daunorubicin levels for evaluation of exposure by measuring elimination half-life will be drawn prior to infusion and at 5, 20 and 40 minutes and hours 1,2,4,8 and 24 post infusion.
Group
Value
95% CI
Patients With Relapsed/Refractory ALL and AML
1.8588
Sponsor's own description
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.
Publications & conference data
3 peer-reviewed publications reference this trial (live from Europe PMC):
NCT07052994 — A Phase Ia/Ib Trial of Revumenib Combined With Cytarabine, Daunorubicin, and Gemtuzumab Ozogamicin (GO) in Frontline and
· Phase 1
· not yet recruiting
NCT07228273 — Induction and Consolidation With Fludarabine, Cytarabine, Idarubicin, and Venetoclax for the Treatment of Acute Myeloid
· Phase 2
· recruiting
NCT06317662 — Testing the Addition of the Anti-cancer Drug Venetoclax and/or the Anti-cancer Immunotherapy Blinatumomab to the Usual C
· Phase 2
· recruiting
NCT06124157 — A Study Testing the Combination of Dasatinib or Imatinib to Chemotherapy Treatment With Blinatumomab for Children, Adole
· Phase 2
· recruiting
NCT06313437 — Revumenib in Combination With 7+3 + Midostaurin in AML
· Phase 1
· recruiting
Other recruiting trials for Relapsed Pediatric ALL
Currently open trials in the same condition.
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· recruiting
NCT05334823 — A Study of pCAR-19B in the Treatment of CD19-positive Relapsed/Refractory B-ALL in Children and Adolescents
· Phase 2
· recruiting
Other Children's Mercy Hospital Kansas City trials
Trials by the same sponsor.
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NCT06520657 — Addressing Social Determinants of Health in Child Obesity Treatment Using Community Health Workers
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Children's Mercy Hospital Kansas City
Last refreshed: 28 June 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04562792.