ClinicalTrials.gg
RecruitingNCT06918054Updated Apr 9, 2025

Hepatoprotective for Children and Adolescent With Acute Lymphoblastic Leukemia

A Phase 4 interventional study of Dietary modification and Supplementation of omega 3 fatty acids in Leukaemia (Acute) and Acute Lymphoblastic Leukemia, sponsored by Ain Shams University. Recruiting at 2 sites in Egypt. Open to participants aged 2 Years to 18 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-04-09.

Primary conditionPrecursor Cell Lymphoblastic Leukemia-LymphomaRegistry: LeukemiaReclassifiedWhy we changed it
Registry
Leukemia — the first condition term the registry derived for this study.
ClinicalTrials.gg
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Why
  1. The study's listed conditions name Precursor Cell Lymphoblastic Leukemia-Lymphoma, a narrower term within Leukemia.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by Ain Shams University · Phase 4, Interventional, and Prevention

From the registry’s dates

  • Primary completion was expected by May 2025, 1 year 6 months ago, but the record still lists the study as recruiting.
  • Registered 1 year after the study started (first participant enrolled Nov 2023, registered Dec 2024).
  • Started Nov 2023; still recruiting 2 years 11 months later.

Help build ClinicalTrials.gg — short surveys, remote interviews or testing, in your language. Take part →

Phase
Phase 4
Study type
Interventional
Enrollment
42
Allocation
Non-randomized
Ages
2 Years to 18 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 25 studies in Precursor Cell Lymphoblastic Leukemia-Lymphoma with a site in Egypt — 8 open to participants now, 10 under way, none of them phase 3. Precursor Cell Lymphoblastic Leukemia-Lymphoma · Egypt.

Planned enrollment
13th of 15
42 · median 90
Started
2023
with 5 others
Phase 4
3 of 25
1 open now
Registered
20th of 25
by date
Lead sponsor
6 of 25
Ain Shams University

Among the 25 studies in Precursor Cell Lymphoblastic Leukemia-Lymphoma with a site in Egypt, this one is the 13th largest by planned enrollment of the 15 interventional ones that give a count, is one of 6 that started in 2023, is one of 3 in phase 4, and was the 20th registered.

Precursor Cell Lymphoblastic Leukemia-Lymphoma

2,584 studies on the registry are indexed under Precursor Cell Lymphoblastic Leukemia-Lymphoma; 473 are open to participants now.

Browse Precursor Cell Lymphoblastic Leukemia-Lymphoma studies →

Open to participants now

8 of the 25 studies in Precursor Cell Lymphoblastic Leukemia-Lymphoma with a site in Egypt are open now. Recruiting first, the newest first:

2 more — sign in →

All 8 open studies →

A study can be open while its sites in Egypt have not opened yet or have stopped. Only those recruiting at a site in Egypt →

Who these studies take

Of the 370 Precursor Cell Lymphoblastic Leukemia-Lymphoma studies recruiting now, 96 (26%) set no upper age limit and 257 (69%) stop at 75 or younger; 247 take children under 18; 29 take healthy volunteers.

This study: 2 Years to 18 Years · all sexes · healthy volunteers too.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

Was this useful?
Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 25 studies in Precursor Cell Lymphoblastic Leukemia-Lymphoma with a site in Egypt, or all of them as a file.
02

Study summary

This current study will implement a proposed whole program of monitoring and prevention acute hepatic injury during the time of induction chemotherapy in children and adolescent with ALL.

Read the detailed description

Children and adolescent with acute lymphoblastic leukemia (ALL) can exhibit a wide spectrum of hepatotoxicity ranging from asymptomatic to clinically significant during induction chemotherapy. Unmonitored hepatic status can lead to a hepatic toxicity that might result in unwarranted interruption of the aimed delivery of dose dense chemotherapy to induce remission and consequent treatment.

To evaluate the effect of chemotherapy in children and adolescent with ALL during induction phase, through recording liver function tests before, during and after induction chemotherapy.

03

Conditions studied

  • Leukaemia (Acute)
  • Acute Lymphoblastic Leukemia

Browse trials for

Keywords

  • Acute Lymphoblastic Leukemia
  • Hepatoprotective program
04

In context

Precursor Cell Lymphoblastic Leukemia-Lymphoma Reclassified

2,584 studies on the registry are indexed under Precursor Cell Lymphoblastic Leukemia-Lymphoma; 473 are open to participants now.

This study's planned enrollment of 42 is close to the median of 40 across 1,952 interventional studies indexed under Precursor Cell Lymphoblastic Leukemia-Lymphoma.

Browse Precursor Cell Lymphoblastic Leukemia-Lymphoma studies →

Lead sponsor

Ain Shams University is the lead sponsor of 1,953 studies on the registry; 430 are open to participants now.

Of its 35 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Compared within Precursor Cell Lymphoblastic Leukemia-Lymphoma, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Leukemia. The counts are of registry records indexed under each term, refreshed daily. How we classify →

05

Who can participate

Ages eligible
2 Years to 18 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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.

Inclusion criteria

Children and adolescents aged from 2 to 18 years newly diagnosed with acute lymphoblastic leukemia during induction phase of chemotherapy treated at Ain Shams

Exclusion criteria

Exclusion Criteria:

Known chronic liver disease.

06

Study design

Phase
Phase 4
Primary purpose
Prevention
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
42 participants (estimated)

Study arms

  • No intervention
    Retrospective historical control

    Retrospective historical control (Arm 1): Children and adolescent with ALL received Total XV induction chemotherapy from 1st June 2018 till 30th April 2023

  • Active comparator
    Interventional arm (Arm 2):Children and adolescent with ALL receiving Total XV induction chemotherap

    Implementation of hepatic supportive program 1. Dietary modification: Patients will follow Mediterranean Diet (MD), this diet is characterized by a high intake of vegetables, fruit, whole cereals, legumes, nuts, and fish and a low intake of red meat and homemade desserts. The main added fat was extra virgin olive oil, with 35-40% kcal from fat (\<10% from saturated fat), 40-44% kcal from carbohydrate, and 20% kcal from protein 2. Evaluation of the risk of malnutrition in hospitalized children with cancer through SCAN score which is simple, quick and valid tool. A score of 0 - 1indicates a low risk of malnutrition. A score of 2 indicates a moderate risk of malnutrition. A score of 3 - 5 indicates a high risk of malnutrition. 3. Supplementation of omega 3 fatty acids ( dose based on weight: \<40 kg-450 mg/day, 40-60 kg-900 mg/day, \>60 kg-1300 mg/day)

    Dietary Supplement: Dietary modification · Dietary Supplement: Supplementation of omega 3 fatty acids

Interventions

  • Dietary supplementDietary modification

    Patients will follow Mediterranean Diet (MD), this diet is characterized by a high intake of vegetables, fruit, whole cereals, legumes, nuts, and fish and a low intake of red meat and homemade desserts. The main added fat was extra virgin olive oil, with 35-40% kcal from fat (\<10% from saturated fat), 40-44% kcal from carbohydrate, and 20% kcal from protein

  • Dietary supplementSupplementation of omega 3 fatty acids

    Supplementation of omega 3 fatty acids ( dose based on weight: \<40 kg-450 mg/day, 40-60 kg-900 mg/day, \>60 kg-1300 mg/day)

07

What researchers measure

Primary outcomes

  1. Implementation a program of hepatic support

    To implement a hepatoprotection interventional program to children and adolescent with ALL during Total XV induction c

    Time frame: Almost 1 year

08

Study locations

2 of 2 sites recruiting
09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Nov 2023 (actual). Primary completion is estimated for May 2025, 18 months after the start.

Of 30 phase 4 interventional studies under Precursor Cell Lymphoblastic Leukemia-Lymphoma, half reached primary completion within 69 months of starting (the median), counting those still running; a quarter within 27 and three quarters within 123. This study's planned 18 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 6, 2024
First posted
Apr 9, 2025
StartActual
Nov 17, 2023
Primary completionEst.
May 2025
CompletionEst.
Aug 2025
Last update
Apr 9, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 9, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06918054
Responsible party
Sponsor
First posted
Apr 9, 2025
Start date
Nov 17, 2023
Primary completion
May 2025 (estimated)
Completion
Aug 2025 (estimated)
Last update
Apr 9, 2025

Study contacts

Fatma S E Ebeid, MD
Contact
fatmaebeid@med.asu.edu.eg
01095569596
Manal El-Sayed, MD
study chair · Faculty of Medicine Ain Shams University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions 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.

Start the discussion