Allogeneic haematopoietic stem cell transplantation (alloHSCT)

Active Ingredient: Treosulfan

Indication for Treosulfan

Population group: only infants (40 days - 1 year old) , children (1 year - 12 years old) , adolescents (12 years - 18 years old) , 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 and in paediatric patients older than one month with malignant and non-malignant diseases.

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

For adults with malignant disease 10 g/m² once daily for 3 consecutive days and for adults with non-malignant disesae 14 g/m² once daily for 3 consecutive days

For:

Dosage regimens

Regimen A, in case that there is malignant tumour

Intravenous, 10 grams treosulfan per square meter of body surface, once daily, over the duration of 3 days.

Regimen B

Intravenous, 14 grams treosulfan per square meter of body surface, once daily, over the duration of 3 days.

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 (FT₁₀ 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).

Elderly

No dose adjustment is necessary in any subset of the elderly population.

Dosage considerations

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

10-14 g/m² once daily for 3 consecutive days

For:

Dosage regimens

Regimen A, in case that patient age in months is ≥ 1 and patient body surface area is < 0.4 m²

Intravenous, 10 grams treosulfan per square meter of body surface, once daily, over the duration of 3 days.

Regimen B, in case that patient age in months is ≥ 1 and patient body surface area is ≥ 0.4 m² and patient body surface area is < 0.9 m²

Intravenous, 12 grams treosulfan per square meter of body surface, once daily, over the duration of 3 days.

Regimen C, in case that patient age in months is ≥ 1 and patient body surface area is ≥ 0.9 m²

Intravenous, 14 grams treosulfan per square meter of body surface, once daily, over the duration of 3 days.

Detailed description

Treosulfan is given in combination with fludarabine, with thiotepa (intensified regimen; FT_10-14 TT regimen) or without thiotepa (FT_10-14 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)
<0.4	10.0
≥0.4 to <0.9	12.0
≥0.9	14.0

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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