Allogeneic haematopoietic stem cell transplantation (alloHSCT)

Active Ingredient: Treosulfan

Indication for Treosulfan

Population group: only children (1 year - 12 years old) , adolescents (12 years - 18 years old)

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:

0.5-14 g/m² once a day for 3 days

Route of admnistration

Intravenous

Defined daily dose

0.5 - 14 g per m² of body surface area (BSA)

Dosage regimen

From 0.5 To 14 g per m² of body surface area (BSA) once every day for 3 day(s)

Detailed description

Treosulfan is given in combination with fludarabine, with thiotepa (intensified regimen; FT10-14 TT regimen) or without thiotepa (FT10-14 regimen).

The recommended dose and schedule of administration is:

  • Treosulfan 10-14 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 30-42 g/m²;

The dose of treosulfan should be adapted to the patient’s BSA as follows:

Body surface area (m²) Treosulfan dose (g/m²)
≤0.510.0
>0.5–1.012.0
>1.014.0
  • 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;
  • Thiotepa (intensified regimen 5 mg/kg twice a day), given as two intravenous infusions over 2-4 hours on day -2 before stem cell infusion (day 0).

The safety and efficacy of treosulfan in children less than 1 month of age has not yet been established.

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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