Lower-dose induction for pediatric AML with G-CSF support
Official title: Outcome of Pediatric Patients With Acute Myeloid Leukemia Treated According to SIOP Guidelines in Developing Countries
Run by Assiut University · NCT07867600 · Data updated 2026-11-12
This study tests a lower-dose induction regimen with G-CSF in children with de novo acute myeloid leukemia to see if it lowers early toxicity without hurting survival.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | Any age to 18 Years |
| Sex | All |
| Enrollment | 33 (estimated) |
| Sponsor | Assiut University Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 2 sites (Asyut, Asyut Governorate and 1 other locations) |
| Status | Recruiting |
| Started | July 28, 2022 |
| Main results expected | July 2028 |
| Study ends | July 2030 |
| Registry record updated | October 9, 2026 |
| Trial ID | NCT07867600 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Children with new (de novo) AML under 18 years of age who can start induction.
✕Probably not a fit
Children with promyelocytic leukemia, Down syndrome with AML under age 4, AML that is secondary to prior conditions or chemotherapy, or those who die before starting treatment may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
The trial investigates a low-dose induction approach using Ara-C and an anthracycline in combination with G-CSF for pediatric patients with de novo AML. It aims to reduce treatment-related morbidity and mortality that are common during induction, especially in resource-limited settings, while maintaining effectiveness. The regimen reflects a balance between minimizing toxicity and preserving the chance of remission, with standard consolidation therapy following induction as appropriate. Enrollment targets pediatric patients under 18 without promyelocytic leukemia, Down syndrome-associated AML under age 4, AML secondary to prior conditions, or prior treatment-related death before initiation. The lead sponsor is Azza Shibl Sayed, with sites in South Egypt at Assiut University and South Egypt Cancer Institute in Assiut, Egypt.
Why it matters
Potential benefit: If successful, this approach could reduce early treatment-related complications and mortality in children with AML, improving overall survival and quality of care in LMIC settings.
How similar studies have gone: Previous similar strategies in pediatric AML have shown mixed results; this study explores a lower-dose induction with G-CSF to reduce toxicity while preserving efficacy.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Denovo pediatric AML patients. * equal or \<18 years old Exclusion Criteria: * Children with promyelocytic leukemia * Down syndrome with AML with age less than 4 years. * AML secondary to myelodysplastic syndrome or prior chemotherapy. * death before treatment initiation
Where it's running
-
South Egypt Cancer Institute, Assiut Univeristy
Asyut, Asyut Governorate, Egypt Recruiting -
South Egypt Cancer Institute, Assiut Univeristy
Asyut, Asyut Governorate, Egypt Recruiting
Study contacts
- Study coordinator: Azza Shibl, MD
- Email: azzashibl@aun.edu.eg
- Phone: 00201021880322
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.