Clinical trial · Interventional
Low Dose Daunorubicin in Pediatric Relapsed/Refractory Acute Leukemia
A Pilot Study of Targeted Daunorubicin Dosing to Overcome Chemotherapeutic Resistance in Children With Relapsed or Refractory Acute Leukemia
NCT04562792CI-TRIAL-00067605completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Refractory Acute Lymphoblastic Leukemia | Acute Lymphoblastic Leukemia | CURATED_BROADER | 0.78 |
| Refractory Acute Myeloid Leukemia | Acute Myeloid Leukemia | CURATED_BROADER | 0.80 |
| Relapsed Pediatric ALL | Childhood Acute Lymphoblastic Leukemia | CURATED_BROADER | 0.78 |
| Relapsed Pediatric AML | Childhood Acute Myeloid Leukemia | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Daunorubicin | Drug | Daunorubicin | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Patients with relapsed/refractory ALL and AML
- description
- Patients in this arm will receive daunorubicin 6.75mg/m2 daily for 5 consecutive days.
- interventionNames
- Drug: Daunorubicin
Primary outcomes (5)
- measure
- Incidence of Low Dose Daunorubicin Feasbility as Assessed by Absolute Blast Count
- timeFrame
- 24 months
- description
- 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.
- measure
- Incidence of Low Dose Daunorubicin Feasbility as Assessed by Extramedullary Leukemia Progression
- timeFrame
- 24 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 1 Year
- Maximum age
- 21 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with pathologically confirmed ALL or AML, whose disease is refractory to two induction therapeutic attempts, or who are in 2nd or greater relapse, or who are in 1st relapse or refractory to a single therapeutic attempt but are unable to receive intensive therapy at the time of consent. * All prior upfront therapies including bone marrow transplant are acceptable. Pulse steroids (of 5 days duration or less in the prior month) administered as part of a routine maintenance therapy are acceptable. * Age 1 to 21 years of age, inclusive * Established central catheter IV access Exclusion Criteria: * Females who are known to be pregnant or lactating * Any Grade 3 or higher Cardiac Disorder per CTCAE version 5 * Patients with echocardiographic evidence of cardiomyopathy (shortening fraction \<27% or ejection fraction \<50%) * Uncontrolled sepsis * Absolute Blast Count \>50 x10(3)/mcL at enrollment or on day 1 of study * Direct hyperbilirubinemia \>5mg/dL * Grade 3 or higher anaphylaxis to daunorubicin * Non-English speaking * Patients, who in the opinion of the PI, are unable to tolerate any study-specific procedures * Patients who have received cyclosporine, tacrolimus or other agents to prevent or treat graft-vs-host disease post bone marrow transplant in the last 14 days * Concurrent investigational drugs or other chemotherapeutic agents (excluding hydroxyurea), immunotherapies or biosimilars during the 5 days of daunorubicin. * Prior cumulative doses of anthracyclines will not be an exclusion regardless of the total cumulative dose previously received.
References
Publications (11)
- BACKGROUNDWard E, DeSantis C, Robbins A, Kohler B, Jemal A. Childhood and adolescent cancer statistics, 2014. CA Cancer J Clin. 2014 Mar-Apr;64(2):83-103. doi: 10.3322/caac.21219. Epub 2014 Jan 31. PMID 24488779
- BACKGROUNDNguyen K, Devidas M, Cheng SC, La M, Raetz EA, Carroll WL, Winick NJ, Hunger SP, Gaynon PS, Loh ML; Children's Oncology Group. Factors influencing survival after relapse from acute lymphoblastic leukemia: a Children's Oncology Group study. Leukemia. 2008 Dec;22(12):2142-50. doi: 10.1038/leu.2008.251. Epub 2008 Sep 25. PMID 18818707
- BACKGROUNDBorowitz MJ, Devidas M, Hunger SP, Bowman WP, Carroll AJ, Carroll WL, Linda S, Martin PL, Pullen DJ, Viswanatha D, Willman CL, Winick N, Camitta BM; Children's Oncology Group. Clinical significance of minimal residual disease in childhood acute lymphoblastic leukemia and its relationship to other prognostic factors: a Children's Oncology Group study. Blood. 2008 Jun 15;111(12):5477-85. doi: 10.1182/blood-2008-01-132837. Epub 2008 Apr 3. PMID 18388178
- BACKGROUNDArmenian SH. Improving screening practices in childhood cancer survivors at risk for treatment-related heart failure. J Clin Oncol. 2014 Dec 10;32(35):3923-5. doi: 10.1200/JCO.2014.58.5562. Epub 2014 Nov 3. No abstract available. PMID 25366690
- BACKGROUNDOeffinger KC, Mertens AC, Sklar CA, Kawashima T, Hudson MM, Meadows AT, Friedman DL, Marina N, Hobbie W, Kadan-Lottick NS, Schwartz CL, Leisenring W, Robison LL; Childhood Cancer Survivor Study. Chronic health conditions in adult survivors of childhood cancer. N Engl J Med. 2006 Oct 12;355(15):1572-82. doi: 10.1056/NEJMsa060185. PMID 17035650
- BACKGROUNDReulen RC, Winter DL, Frobisher C, Lancashire ER, Stiller CA, Jenney ME, Skinner R, Stevens MC, Hawkins MM; British Childhood Cancer Survivor Study Steering Group. Long-term cause-specific mortality among survivors of childhood cancer. JAMA. 2010 Jul 14;304(2):172-9. doi: 10.1001/jama.2010.923.