# US 2014/0154304 A1 · Combination therapy with volasertib

> Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt

- Number: US 2014/0154304 A1
- Document ID: US20140154304A1
- Status: Published application
- Kind: A1
- Application number: 14/088,948
- Filed: 2013-11-25
- Published: 2014-06-05
- Earliest claimed: 2012-11-30
- Assignees: Boehringer Ingelheim International GmbH
- Inventors: Tillmann TAUBE
- Web page: https://patentgrep.com/patent/US20140154304A1

## CPC

- A61K 31/519: ortho- or peri-condensed with heterocyclic rings
- A61K 9/127: Synthetic bilayered vehicles, e.g. liposomes or liposomes with cholesterol as the only non-phosphatidyl surfactant
- A61K 31/704: attached to a condensed carbocyclic ring system, e.g. sennosides, thiocolchicosides, escin, daunorubicin {(digitoxin A61K31/7048)}
- A61K 31/7068: having oxo groups directly attached to the pyrimidine ring, e.g. cytidine, cytidylic acid
- A61K 31/7076: containing purines, e.g. adenosine, adenylic acid
- A61K 38/193: {Colony stimulating factors [CSF]}
- A61P 35/02: specific for leukemia
- A61P 43/00: Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
- A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D)
- A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS

## Abstract

Disclosed is the use of Volasertib or a salt or a hydrate thereof for treating patients suffering from acute myeloid leukemia (AML) comprising administering a high dose of Volasertib in combination with fludarabine, cytarabine and Granulocyte colony-stimulating factor (GCSF) or in combination with fludarabine, cytarabine, GCSF and a daunorubicin citrate liposome injection.

## Claims

### Claim 1

A method of treating acute myeloid leukemia (AML) comprising administration to a patient suffering from AML
a) an effective amount (50-500 μg/m2 body surface area) of GCSF at day 0, 1, 2, 3, 4 and 5 during a 6 day treatment cycle (days 0 to 5);
b) an effective amount (10-100 mg/m2 body surface area) of fludarabine at day 1, 2, 3, 4 and 5 during said 6 day treatment cycle;
c) an effective amount (500-4000 mg/m2 body surface area) of cytarabine at day 1, 2, 3, 4 and 5 during said 6 day treatment cycle; and
d) an effective amount (10 to 350 mg/m2 body surface area) of Volasertib, or a pharmaceutically acceptable salt or hydrate thereof, at least one day up to 5 days during said 6 day treatment cycle.

### Claim 2

A method of treating acute myeloid leukemia (AML) comprising administration to a patient suffering from AML
a) an effective amount (50-500 μg/m2 body surface area) of GCSF by i.v. infusion at day 0, 1, 2, 3, 4 and 5 during a 6 day treatment cycle (days 0 to 5),
b) an effective amount (10-100 mg/m2 body surface area) of fludarabine at day 1, 2, 3, 4 and 5 during said 6 day treatment cycle,
c) an effective amount (500-4000 mg/m2 body surface area) of cytarabine at day 1, 2, 3, 4 and 5 during said 6 day treatment cycle,
d) an effective amount (500-4000 mg/m2 body surface area) of daunorubicin citrate liposome at day 1, 3 and 5 during said 6 day treatment cycle, and
e) an effective amount (10 to 350 mg/m2 body surface area) of Volasertib, or a pharmaceutically acceptable salt or hydrate thereof, at least one day up to 5 days during said 6 day treatment cycle.

### Claim 3 (depends on 2)

The method of claim 2 comprising administration to a patient suffering from AML
a) an effective amount (200 μg/m2 body surface area) of GCSF by i.v. infusion at day 0, 1, 2, 3, 4 and 5 during a 6 day treatment cycle (days 0 to 5),
b) an effective amount (30 mg/m2 body surface are) of fludarabine at day 1, 2, 3, 4 and 5 during said 6 day treatment cycle,
c) an effective amount (2000 mg/m2 body surface area) of cytarabine at day 1, 2, 3, 4 and 5 during said 6 day treatment cycle,
d) an effective amount (2000 mg/m2 body surface area) of daunorubicin citrate liposome at day 1, 3 and 5 during said 6 day treatment cycle, and
e) an effective amount (10, 50, 100, 150, 200, 250, 300, or 350 mg/m2 body surface area) of Volasertib, or a pharmaceutically acceptable salt or hydrate thereof, at least one day up to 5 days during said 6 day treatment cycle.

### Claim 4

A pharmaceutical composition comprising an effective amount of fludarabine, cytarabine and GCSF optionally together with an instruction for administration of the active ingredients to a patient suffering from AML, wherein the composition additionally comprises an effective amount of Volasertib or a pharmaceutically acceptable salt or hydrate thereof.

### Claim 5 (depends on 4)

The pharmaceutical composition according to claim 4 further comprising an effective amount of daunorubicin citrate liposome.