Allogeneic haematopoietic stem cell transplantation (alloHSCT)

Active Ingredient: Treosulfan

Indication for Treosulfan

Population group: only adults (18 years old or older)

Treosulfan in combination with fludarabine is indicated as part of conditioning treatment prior to allogeneic haematopoietic stem cell transplantation (alloHSCT) in adult patients with malignant and non-malignant diseases, and in paediatric patients older than one month with malignant diseases.

For this indication, competent medicine agencies globally authorize below treatments:

10-14 g/m² once a day for 3 days

Route of admnistration

Intravenous

Defined daily dose

10 - 14 g per m² of body surface area (BSA)

Dosage regimen

From 10 To 14 g per m² of body surface area (BSA) once every day for 3 day(s)

Detailed description

Adults with malignant disease

Treosulfan is given in combination with fludarabine.

The recommended dose and schedule of administration is:

  • Treosulfan 10 g/m² body surface area (BSA) per day as a two-hour intravenous infusion, given on three consecutive days (day -4, -3, -2) before stem cell infusion (day 0). The total treosulfan dose is 30 g/m²;
  • Fludarabine 30 mg/m² BSA per day as a 0.5-hour intravenous infusion, given on five consecutive days (day -6, -5, -4, -3, -2) before stem cell infusion (day 0). The total fludarabine dose is 150 mg/m²;
  • Treosulfan should be administered before fludarabine on days -4, -3, -2 (FT 10 regimen).

Adults with non-malignant disease

Treosulfan is given in combination with fludarabine with or without thiotepa.

The recommended dose and schedule of administration is:

  • Treosulfan 14 g/m² body surface area (BSA) per day as a two-hour intravenous infusion, given on three consecutive days (day -6, -5, -4) before stem cell infusion (day 0). The total treosulfan dose is 42 g/m²;
  • Fludarabine 30 mg/m² BSA per day as a 0.5-hour intravenous infusion, given on five consecutive days (day -7, -6, -5, -4, -3) before stem cell infusion (day 0). The total fludarabine dose is 150 mg/m²;
  • Treosulfan should be administered before fludarabine on days -6, -5, -4 (FT14 regimen).

Thiotepa 5 mg/kg twice a day, given as two intravenous infusions over 2–4 hours on day -2 before stem cell infusion (day 0).

Dosage considerations

Treosulfan is for intravenous use as a two-hour infusion.

Active ingredient

Treosulfan

Treosulfan is a prodrug of a bifunctional alkylating agent with cytotoxic activity to haematopoietic precursor cells. The activity of treosulfan is due to the spontaneous conversion into a mono-epoxide intermediate and L-diepoxybutan. Treosulfan has a broad antineoplastic and antileukaemic activity.

Read more about Treosulfan

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