An interventional study of Low dose Ara C/ anthracycline combined with GCSF in Pediatric Acute Myeloid Leukemia Induction, sponsored by Azza Shibl Sayed. Recruiting at 2 sites in Egypt. Open to participants aged Up to 18 Years. Per ClinicalTrials.gov, last updated 2026-10-09.
Sponsored by Azza Shibl Sayed · Not applicable, Interventional, and Treatment
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.
Acute myeloid leukemia (AML) accounts for 15% to 20% of all childhood leukemias. In most children, AML presents as a de novo entity, but in a minority, it is a secondary malignancy. Acute myeloid leukemia is a heterogeneous disease and its diagnosis involves a combination of diagnostic analyses including morphology, immunophenotyping, cytochemistry, and leukemic blasts derived from peripheral blood or bone marrow demonstrating cytogentic and molecular characteristics. The treatment of AML comprises induction of remission followed by intensive consolidation therapy with the use of chemotherapy alone or in combination with allogeneic hematopoietic stem cell transplantation (HSCT). The standard chemotherapy courses for remission induction and consolidation are typically accompanied by an extended period of myelosuppression during which there is significant morbidity and mortality. Treatment-related morbidity and treatment-related mortality (TRM) represents a significant challenge in pediatric AML worldwide. In low- and middle- income countries (LMICs), mortality associated with initial disease and treatment can be up to 50 %. It is now well understood and accepted that if the relapse rate with a given therapy is excessive then the treatment may need intensification; however, if toxic death rates are too high, de-intensification may save more lives, depending on the enhancement of supportive care. During tumor formation, new mutations are constantly occurring giving rise to drug resistant mutation at a very low frequency. With the pre- existence of small drug-resistant sub clones giving the current chemotherapy at the maximum tolerated dose that eliminates a dominant drug sensitive clone might allow the competitive release of resistant sub clones to undergo accelerated growth in a resource-rich environment, resulting in more rapid disease progression or relapse. Reducing chemotherapy drug dosage may be a logical way to maintain a stable population of sensitive sub clone, thereby restricting the growth of resistant cell. Intensifying the induction courses can decrease relapse rates but not improve OS. The initial concerns for offering a low dose intensity regimen for children with AML in most studies was based on the high risk of toxicity related deaths or treatment abandonment specially for children in limited resources countries. According to SIOP/PODC, patients with AML treated with low dose chemotherapy (LDC/G-CSF) receive only a two -drug regimen with 10 \& 2 times lower doses of cytrabine \& anthracyclines respectively than those given standard AML remission induction regimens. Although the mechanism \& clinical efficacy of LDC/G-CSF are still unknown, it is possible that granulocyte colony stimulating factor (G-CSF) makes leukemia cells more vulnerable to chemotherapy through sensitization or priming.G-CSF can also reduce the overall viability of AML cells when cocultured with BM stroma but not alone. G- CSF mobilizes T-regulatory cells and has other immunomodulatory effects.
3,667 studies on the registry are indexed under Leukemia, Myeloid, Acute; 816 are open to participants now.
This study's planned enrollment of 33 is below the median of 40 across 3,005 interventional studies indexed under Leukemia, Myeloid, Acute.
Browse Leukemia, Myeloid, Acute studies →This is the only study on the registry with Azza Shibl Sayed as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
low dose Ara C, mitothantrone concurrently with GCSF
Combination Product: Low dose Ara C/ anthracycline combined with GCSF
the established, standard induction regimen, ADE
Combination Product: Low dose Ara C/ anthracycline combined with GCSF
Drug pages: Cytarabine · Anthracyclines
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
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
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
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
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
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
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
Duration of neutrophil recovery after low dose induction
calculating days of neutropenia after dose till recovery
Time frame: 6 years
Plan to share: Yes
Started Jul 2022 (actual). Primary completion is estimated for Jul 2028, 72 months after the start.
Of 132 non-industry interventional studies with no phase under Leukemia, Myeloid, Acute, half reached primary completion within 49 months of starting (the median), counting those still running; a quarter within 26 and three quarters within 128. This study's planned 72 months is above that.
Counting every sponsor, half of 139 studies reached it within 47 months; a quarter within 25 and three quarters within 123.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drugs tested here: Cytarabine · Anthracyclines