NCT07867600

Brief Summary

the standard induction treatment for pediatric acute myeloid leukemia has high early morbidity and mortality that jeopardize the outcome especially in developing countries. SIOP recommended lower dose induction synergistic G- CSF to minimize these unwanted toxicities. the study aimed at minimizing the toxicities during induction without jeopardizing the survival.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
33

participants targeted

Target at P25-P50 for not_applicable

Timeline
46mo left

Started Jul 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress53%
Jul 2022Jul 2030

Study Start

First participant enrolled

July 28, 2022

Completed
4.2 years until next milestone

First Submitted

Initial submission to the registry

September 28, 2026

Completed
11 days until next milestone

First Posted

Study publicly available on registry

October 9, 2026

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2028

Expected
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2030

Last Updated

October 9, 2026

Status Verified

September 1, 2026

Enrollment Period

5.9 years

First QC Date

September 28, 2026

Last Update Submit

October 7, 2026

Conditions

Pediatric Acute Myeloid Leukemia Induction

Keywords

MAG/GCSFpediatric AMLSIOP-PODCSurvivalToxicity

Outcome Measures

Primary Outcomes (2)

  • Efficacy of low dose induction for pediatric AML

    assessment of each induction response by performing bone marrow aspirate and analysis of each participant response. BM response may be: CR (complete remission), PR (partial remission), NR(no response) or induction deaths

    6 years

  • number of participants with low dose induction-related Toxicity assessed by CTCAE v5

    the common terminology criteria for adverse events (CTCAE v5) using a range of grades (1-5): 1. mild 2. moderate 3. severe 4. life threatening 5. death

    6 years

Secondary Outcomes (5)

  • Event free survival of AML patients with low dose induction

    10 years

  • Overall survival of pediatric patients with AML using low dose induction

    10 years

  • Event Free Survival of unfavourable and favourable sub groups of AML patients with low dose induction

    10 years

  • number of participants with Long term low dose induction related- toxicities assessed by CTCAE v5

    10 years

  • Duration of neutrophil recovery after low dose induction

    6 years

Study Arms (2)

low dose induction/GCSF

EXPERIMENTAL

low dose Ara C, mitothantrone concurrently with GCSF

Combination Product: Low dose Ara C/ anthracycline combined with GCSF

Standard induction

ACTIVE COMPARATOR

the established, standard induction regimen, ADE

Combination Product: Low dose Ara C/ anthracycline combined with GCSF

Interventions

Low dose Ara C/ anthracycline combined with GCSFCOMBINATION_PRODUCT

low dose mitothantrone and Ara C concurrently with G-CSF during induction treatment of pediatric acute myeloid leukemia to be compared with the standard induction

Standard inductionlow dose induction/GCSF

Eligibility Criteria

AgeUp to 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Denovo pediatric AML patients.
  • equal or \<18 years old

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

South Egypt Cancer Institute, Assiut Univeristy

Asyut, Asyut Governorate, 71515, Egypt

RECRUITING

South Egypt Cancer Institute, Assiut Univeristy

Asyut, Asyut Governorate, 71515, Egypt

RECRUITING

Related Publications (1)

  • Bansal D, Davidson A, Supriyadi E, Njuguna F, Ribeiro RC, Kaspers GJL. SIOP PODC adapted risk stratification and treatment guidelines: Recommendations for acute myeloid leukemia in resource-limited settings. Pediatr Blood Cancer. 2023 Nov;70(11):e28087. doi: 10.1002/pbc.28087. Epub 2019 Nov 27.

    PMID: 31774234RESULT

MeSH Terms

Interventions

Cytarabine

Intervention Hierarchy (Ancestors)

CytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsArabinonucleosidesNucleosidesNucleic Acids, Nucleotides, and Nucleosides

Central Study Contacts

Azza Shibl, MD

CONTACT

00201021880322azzashibl@aun.edu.eg

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
assisstant professor of peditric oncology

Study Record Dates

First Submitted

September 28, 2026

First Posted

October 9, 2026

Study Start

July 28, 2022

Primary Completion (Estimated)

July 1, 2028

Study Completion (Estimated)

July 1, 2030

Last Updated

October 9, 2026

Record last verified: 2026-09

Data Sharing

IPD Sharing
Will share

Locations

EG(2)