NCT04793919 is a Phase 2 clinical trial of Mylotarg in Acute Promyelocytic Leukemia, sponsored by Associazione Italiana Ematologia Oncologia Pediatrica.

Who is sponsoring NCT04793919?

NCT04793919 is sponsored by Associazione Italiana Ematologia Oncologia Pediatrica.

What drugs are being tested in NCT04793919?

Interventions in NCT04793919: Mylotarg, Arsenic Trioxide, All-trans retinoic acid.

What condition does NCT04793919 study?

NCT04793919 studies Acute Promyelocytic Leukemia.

Is NCT04793919 still recruiting?

NCT04793919 is currently recruiting now. Last updated 15 April 2024.

Last reviewed 2024-04-15 · How we verify

NCT04793919

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Treatment Study for Children and Adolescents With Acute Promyelocytic Leukemia

Recruiting now Phase 2 Last updated 15 April 2024

What this trial tests

Phase 2 trial testing Mylotarg in Acute Promyelocytic Leukemia in 89 participants. Currently enrolling.

Timeline

9 October 2019

Primary endpoint
9 October 2025

10 October 2027

Quick facts

Lead sponsor	Associazione Italiana Ematologia Oncologia Pediatrica
Phase	Phase 2
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	89
Start date	9 October 2019
Primary completion	9 October 2025
Estimated completion	10 October 2027
Sites	31 locations across Denmark, France, Italy, Netherlands, Belgium, Sweden, Ireland, Germany

Drugs / interventions tested

Mylotarg (gemtuzumab-ozogamicin) — full drug profile →
Arsenic Trioxide (ARSENIC TRIOXIDE) — full drug profile →
All-trans retinoic acid

Conditions studied

Acute Promyelocytic Leukemia — all drugs for Acute Promyelocytic Leukemia →

Sponsor

Associazione Italiana Ematologia Oncologia Pediatrica — full company profile →

Who can join

Under 18, any sex, with Acute Promyelocytic Leukemia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The trial is open to all patients with a diagnosis of acute promyelocytic leukemia (APL) who are PCR-positive for the PML-RARα transcript and less than 18 years of age.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

Targeting Autophagy with Natural Products as a Potential Therapeutic Approach for Cancer.
Al-Bari MAA, Ito Y, Ahmed S, Radwan N, et al · · 2021 · cited 34× · PMID 34575981 · DOI 10.3390/ijms22189807
Nuclear receptors in health and disease: signaling pathways, biological functions and pharmaceutical interventions.
Jin P, Duan X, Huang Z, Dong Y, et al · · 2025 · cited 21× · PMID 40717128 · DOI 10.1038/s41392-025-02270-3
All-trans retinoic acid in hematologic disorders: not just acute promyelocytic leukemia.
Chen Y, Tong X, Lu R, Zhang Z, et al · · 2024 · cited 16× · PMID 39027338 · DOI 10.3389/fphar.2024.1404092
Genomic DNA-based measurable residual disease monitoring in pediatric acute myeloid leukemia: unselected consecutive cohort study.
Zaliova M, Zuna J, Winkowska L, Janotova I, et al · · 2024 · cited 2× · PMID 38001170 · DOI 10.1038/s41375-023-02083-9
Chemotherapy-free treatment for acute promyelocytic leukemia: the pediatric view of a revolutionary tale.
Masetti R, Muratore E, Leardini D, Baccelli F, et al · · 2023 · cited 2× · PMID 37124521 · DOI 10.3389/fonc.2023.1135350
Targeting pattern recognition receptors for cancer therapy: Mechanisms and strategies.
Ouyang D, Chen R, Xie H, Yang X, et al · · 2025 · cited 1× · PMID 41311391 · DOI 10.1016/j.apsb.2025.09.007
Real-world experience of paediatric acute promyelocytic leukaemia in the United Kingdom and Ireland.
Vedi A, Vedi A, Leiter SM, Memon IL, et al · · 2025 · cited 1× · PMID 39551717 · DOI 10.1111/bjh.19843
Crosstalk of thioredoxin system and programmed cell death: from pathophysiology to novel therapy.
Wu Y, Su Y, Pan F, Jin F, et al · · 2026 · PMID 42155152 · DOI 10.1016/j.redox.2026.104209

Verify or expand the search:

Other trials of Mylotarg

Trials testing the same drug.

NCT05599360 — Vyxeos for Induction of Low- or Intermediate-risk. · Phase 2 · active not recruiting
NCT04849910 — Allogeneic Engineered Hematopoietic Stem Cell Transplant (HCT) Lacking the CD33 Protein, and Post-HCT Treatment With Myl · Phase 1, PHASE2 · terminated

Other recruiting trials for Acute Promyelocytic Leukemia

Currently open trials in the same condition.

NCT05832320 — Optimum Induction Therapy of Low-risk APL · NA · recruiting
NCT04687176 — Frontline Oral Arsenic Trioxide for APL · Phase 2 · recruiting

Other Associazione Italiana Ematologia Oncologia Pediatrica trials

Trials by the same sponsor.

NCT07368582 — Real World Pediatric Oncology Rehabilitation in Italy ( ReWori ) · recruiting
NCT06419426 — Prospective Study on Febrile Batteries in Pediatric Oncohaematological Patients (SuBiTo) · active not recruiting
NCT04862130 — Validation of the GMFM-88 Scale and of the FAAP-O Scale in Pediatric Patients Affected by Cancer · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04793919 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Associazione Italiana Ematologia Oncologia Pediatrica
Last refreshed: 15 April 2024

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04793919.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing