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Low Dose Induction for Pediatric Acute Myeloid Leukemia Patients

ConditionPediatric Acute Myeloid Leukemia Induction
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeUp to 18
SponsorAzza Shibl Sayed

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Denovo pediatric AML patients.

equal or <18 years old

Disqualifiers

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

Trial design

Design model

Sequential

Treatments tested in this trial

  • Low dose Ara C/ anthracycline combined with GCSF

    Combination 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

Treatment groups

33 Participants
are divided into 2 treatment groups
Group A: low dose induction/GCSFExperimental treatment 1 intervention
Group B: Standard inductionActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
6 years
2

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

Time frame
6 years

Secondary outcomes

1

Event free survival of AML patients with low dose induction

time from enrollment to occurrence of any event (death, induction failure, refractory relapse or 2nd malignancy) or to last follow up of living patients using Kaplan Meier and hazard cox regression survival analysis

Time frame
10 years
2

Overall survival of pediatric patients with AML using low dose induction

time from enrollment to occurrence of death of any cause or to last follow up of living patients using Kaplan Meier and hazard cox regression survival analysis

Time frame
10 years
3

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

time from enrollment to occurrence of any event (death, induction failure, refractory relapse or 2nd malignancy) or to last follow up of living patients using Kaplan Meier and hazard cox regression survival analysis

Time frame
10 years
4

number of participants with Long term low dose induction related- toxicities 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

Time frame
10 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Azza Shibl Sayed

Lead sponsor

Assiut University

Sponsor institution

Source ClinicalTrials.gov
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