Treatment regimen

Tretinoin (ATRA) and arsenic trioxide in APL

Chemotherapy-free treatment of low-‎ and intermediate-risk acute promyelocytic leukaemia

Updated: 28 October 20261 min read3 references

Summary for doctors

  • Low-‎ and intermediate-risk APL (white cell count 10,000 or less) [1].
  • Start ATRA at the first clinical suspicion, before genetic confirmation.
  • Most deaths in the first days are from bleeding: keep platelets and fibrinogen up.

Dose and schedule

ATRA + ATO

Low- and intermediate-risk APL

Low-‎ and intermediate-risk APL

DrugDoseRouteSchedule
Induction
Tretinoin (ATRA)45 mg/m² a day in two dosesOralDaily until complete remission
Arsenic trioxide0.15 mg/kgIVDaily until complete remission (maximum 60 days)
Consolidation
Arsenic trioxide0.15 mg/kgIV5 days a week, 4 weeks on and 4 weeks off; 4 courses
Tretinoin (ATRA)45 mg/m² a dayOral2 weeks on, 2 weeks off; 7 courses
Cycle length
Induction until remission; consolidation about 7 months
Duration
Induction and consolidation (no maintenance)

As in APL0406 [1]. In high-risk APL (white cell count above 10,000), chemotherapy (idarubicin) or gemtuzumab is added.

Dose source: [2, 3].

Evidence: APL0406 (2013)

Doses follow the trial protocol, guideline or official drug label (source given in the notes of each regimen). Before prescribing, check blood counts, renal and hepatic function, drug interactions and the patient’s condition, and adjust the dose according to the drug label.

Premedication and supportive care

  • Coagulation: keep platelets above 30,000 to 50,000 and fibrinogen above 150 mg/dL with transfusions.
  • Differentiation syndrome (fever, dyspnoea, weight gain, hypotension): dexamethasone 10 mg IV twice a day at the first sign; with a high white cell count, steroid prophylaxis.
  • Arsenic: keep potassium and magnesium in the high-normal range and avoid QT-prolonging drugs.

Monitoring and dose adjustment

  • ECG (QTc) before starting and weekly; QTc above 500: hold arsenic.
  • PCR for PML-RARA after consolidation and during follow-up.
  • ATRA headache and raised intracranial pressure (especially in young people).

Main evidence

Show detailsHide

APL0406: 2-year event-free survival 97% with ATRA-arsenic vs 86% with ATRA-chemotherapy, with less haematological toxicity [1]. Read more: APL treatment without chemotherapy.

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References

3 references
Show all references, 1 with a study cardClose the reference list

Numbers in the text, such as [1], refer to these sources. Sources with a “Study card” button are summarised in the site’s evidence library.

  1. 1
    Retinoic acid and arsenic trioxide for acute promyelocytic leukemiaLo-Coco F, Avvisati G, Vignetti M, et al · N Engl J Med · 2013;369:111-21
    Study cardDOIPubMed Back to text: 1 2 3
  2. 2
    TRISENOX (ARSENIC TRIOXIDE) — Prescribing InformationCephalon, LLC · FDA label · 2026
  3. 3
    TRETINOIN — Prescribing InformationPar Health Usa, LLC · FDA label · 2026

This page is based on reputable scientific sources and was last updated on 28 October 2026. The content of this website is for educational and informational purposes only and does not replace consultation, diagnosis or treatment by a specialist physician. Consult your treating physician about any treatment decision.