Originele protocol

Inclusion criteria

  • Age 18-75 years
  • ECOG performance status ≤ 3.
  • Morphological diagnosis of APL (FAB-M3 or M3 variant). Those cases without typical morphology but with PML-RARa rearrangement should also be included.
  • Genetic diagnosis: t(15;17) demonstrated by conventional karyotyping, PML-RARa rearrangement detected by RT-PCR or FISH, microspeckled PML protein pattern demonstrated by PG-M3 monoclonal antibody. Obviously, the result of these tests may become available after having initiated the treatment based on a tentative morphological diagnosis.

Exclusion criteria

  • Age >75 years (the treatment with this protocol can be considered on an individual basis)
  • Absence of PML-RARa rearrangement.
  • The patient must not have received any systemic definitive treatment for APL, including cytotoxic chemotherapy or retinoids. Prior therapy with corticosteroids, hydroxiurea or leukapheresis will not exclude the patient.
  • Prior chemotherapy or radiotherapy for the treatment of prior malignancy.
  • Presence of an associated neoplasm.
  • Presence of a severe psychiatric disease.
  • HIV seropositivity.
  • Contraindication for intensive chemotherapy, especially to anthracyclines.
  • Serum creatinine ≥ 250 μmol/l (≥ 2.5 mg/dL)
  • Bilirubin, alkaline phosphatase, or SGOT > 3 times the upper normal limit
  • Positive pregnancy test.


Klik hier voor flowschema.