Phase 2 Leukaemia Trial, Recruiting NCT04793919 Sponsor: Associazione Italiana Ematologia Oncologia Pediatrica Condition: Leukaemia
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Phase 2 Leukaemia Trial, Recruiting

NCT04793919
Recruiting Phase 2

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • People under 18 years of age who have been newly diagnosed with a type of blood cancer called APL (acute promyelocytic leukaemia), confirmed by a specific genetic marker known as the PML/RARα fusion gene
  • Cases where a parent or legal guardian has provided written consent for the child to participate

Who may not be able to join:

  • People initially suspected of having APL but later found not to have the specific PML/RARα genetic marker — the trial site would withdraw these patients and move them to a different treatment plan
  • People with serious liver problems, indicated by certain blood test results being significantly above normal levels (confirm with trial site)
  • People with kidney function that is significantly below normal for their age, based on blood test results (confirm with trial site)
  • People with significant heart rhythm problems, abnormal heart test (EKG) results, or reduced heart function below certain thresholds (confirm with trial site)
  • People with nerve damage or nerve-related conditions (neuropathy)
  • People who currently have another active cancer diagnosis
  • People with a severe, uncontrolled life-threatening infection
  • People who are pregnant or breastfeeding
  • People who have already received alternative treatment for APL, either because APL was not initially suspected or because the standard trial medicines were not available at the time

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 16 July 2026
Phase 2: approximately ~30% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: Fanco Locatelli, Prof, Dept. of Pediatric Hematology Oncology - Bambino Gesù Children's Hospital Rome

Phone: 0039 051 2144667

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 2
Sponsor
Associazione Italiana Ematologia Oncologia Pediatrica
Registry
ClinicalTrials.gov
Start date
9 October 2019
Est. completion
9 October 2025

Where this trial is recruiting

🇧🇪 Belgium 🇨🇿 Czechia 🇩🇰 Denmark 🇫🇷 France 🇩🇪 Germany 🇮🇪 Ireland 🇮🇱 Israel 🇮🇹 Italy 🇳🇱 Netherlands 🇵🇹 Portugal 🇪🇸 Spain 🇸🇪 Sweden

Primary endpoints

Event Free Survival (EFS) probability

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 16 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov