Compounds for treating lymphoma or a t-cell malignant disease
AssigneePurdue Pharma L.P.
InventorsKatarina Hilgier, Francisco Ibanez Lopez, Thomas Jorg Mehrling
Life of this patent
Estimating the term…
Abstract
The invention relates to tinostamustine for use in the treatment of lymphoma or a T-cell malignant disease. Tinostamustine may cause side effects when administered to a patient, and it is desirable to minimise such effects. The present invention defines an improved treatment, wherein the dose of tinostamustine administered is varied based on the patients platelet count.
Claims23
Tinostamustine or a pharmaceutically acceptable salt thereof for use in the treatment of lymphoma or a T-cell malignant disease in a patient, wherein the treatment involves:
- (a) determining whether the patient's initial platelet count is equal to or above a first value, equal to or below a second value, or between the first and second values, wherein the first value is greater than the second value;
- and
- (b) if the initial platelet count is above the first value then administering a first amount of the tinostamustine or pharmaceutically acceptable salt thereof to the patient, if the initial platelet count is equal to or below the second value then administering a second amount of the tinostamustine, and if the initial platelet count is between the first and second values then administering a third amount of the tinostamustine, wherein the first amount is greater than the third amount and the third amount is greater than the second amount.
Tinostamustine or a pharmaceutically acceptable salt thereof for use in the treatment of lymphoma or a T-cell malignant disease in a patient, wherein the patient has a baseline platelet count of greater than or equal to 200×109/L and the tinostamustine or pharmaceutically acceptable salt thereof is administered at a dose of 95 mg/m2 or greater (for example 95-105 mg/m2 e.g. 100 mg/m2) based on free tinostamustine and the patient's body surface area.
Tinostamustine or a pharmaceutically acceptable salt thereof for use in the treatment of lymphoma or a T-cell malignant disease in a patient, wherein the patient has a baseline platelet count of between 100×109/L and 200×109/L and the tinostamustine or pharmaceutically acceptable salt thereof is administered at a dose of 75-85 mg/m2 (for example 80 mg/m2) based on free tinostamustine and the patient's body surface area.
Tinostamustine or a pharmaceutically acceptable salt thereof for use in the treatment of lymphoma or a T-cell malignant disease in a patient, wherein the patient has a baseline platelet count of less than or equal to 100×109/L and the tinostamustine or pharmaceutically acceptable salt thereof is administered at a dose of 54 mg/m2 or lower (for example 45-54 mg/m2 e.g. 50 mg/m2) based on free tinostamustine and the patient's body surface area.
Tinostamustine or a pharmaceutically acceptable salt thereof for use according to any preceding claim, wherein the tinostamustine or pharmaceutically acceptable salt thereof is administered intravenously.
Tinostamustine or a pharmaceutically acceptable salt thereof for use in the treatment of lymphoma or a T-cell malignant disease in a patient, wherein the tinostamustine or pharmaceutically acceptable salt thereof is administered:
- intravenously;
- at a dose of from 20-100 mg/m2 based on free tinostamustine and the patient's body surface area, for example 95-105 mg/m2, 75-85 mg/m2, 55-65 mg/m2, 45-55 mg/m2 or 35-45 mg/m2 (e.g. 100 mg/m2;
- 80 mg/m2, 60 mg/m2, 50 mg/m2 or 40 mg/m2);
- and
- over a period of time which is 45-75 minutes, for example 50-70 minutes or 55-65 minutes e.g. 60 minutes.
Tinostamustine or a pharmaceutically acceptable salt thereof for use according to any preceding claim, wherein tinostamustine is in the form of a pharmaceutically acceptable salt which is the hydrochloride, hydrobromide, hydroiodide, sulfate, bisulfate, sulfamate, nitrate, phosphate, citrate, methanesulfonate, trifluoroacetate, glutamate, glucuronate, glutarate, malate, maleate, oxalate, succinate, fumarate, tartrate, tosylate, mandelate, salicylate, lactate, p-toluenesulfonate, naphthalenesulfonate or acetate.
Tinostamustine or a pharmaceutically acceptable salt thereof for use according to any preceding claim, wherein tinostamustine is in the form of the free compound i.e. is not in the form of a pharmaceutically acceptable salt.
Tinostamustine or a pharmaceutically acceptable salt thereof for use according to any preceding claim, wherein the lymphoma is relapsed or refractory lymphoma.
Tinostamustine or a pharmaceutically acceptable salt thereof for use according to any preceding claim, wherein the lymphoma is:
- Hodgkin lymphoma;
- or
- non-Hodgkin lymphoma, for example NK/T-cell lymphoma (non-Hodgkin lymphoma that develops from natural killer cells or T lymphocytes), peripheral T-cell lymphoma (PTCLcutaneous T-cell lymphoma (CTCL) or anaplastic large cell lymphoma (ALCL).
Tinostamustine or a pharmaceutically acceptable salt thereof for use according to any preceding claim, wherein the tinostamustine or the pharmaceutically acceptable salt thereof is used as a monotherapy.
Tinostamustine or a pharmaceutically acceptable salt thereof for use according to any preceding claim, wherein the tinostamustine or the pharmaceutically acceptable salt thereof is used in combination with one or more other compounds or therapies.
Dependencies are inferred from the claim text.