IP Library Granted Patent US 8,859,502
Granted Patent B2
US 8,859,502 · App. 13/229,581 · Granted Oct 14, 2014

Therapy for MLL-rearranged leukemia

Inventors: Ronald Stam (Rhoon, NL); Dominique J. P. M. Stumpel (Rotterdam, NL)
Assignee: Celgene Corporation
A61K31/165A61K31/4402A61K31/20A61K31/245C12Q2600/106C12Q2600/118C12Q1/6886G01N2800/52A61K31/167A61K31/19A61K38/15G01N33/57426A61K45/06C12Q2600/158A61K31/4406A61K31/7068C12Q2600/154
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Quick Facts
Patent No.
US 8,859,502
App. No.
13/229,581
Granted
Oct 14, 2014
Kind
B2
Abstract

Provided are methods for treating MLL-rearranged ALL by administering to a patient an HDAC inhibitor alone or in combination with a DNA demethylating agent. Also provided are methods of treating MLL-rearranged infant ALL. Methods of treating cells by these agents are also provided. Additionally, disclosed is a method for screening for compounds capable to treat MLL-rearranged ALL, in particular, MLL-rearranged infant ALL. In one embodiment, the HDAC inhibitor is romidepsin.

Claims (11)

1. A method of treating a mixed-lineage leukemia (MLL)-rearranged infant acute lymphoid leukemia (ALL) comprising administering to a patient romidepsin in combination with a DNA demethylating agent selected from the group consisting of 5-azacytidine (azacytidine), 5-azadeoxycytidine (decitabine), zebularine and procaine.

2. The method of claim 1 , wherein the dose of romidepsin ranges from about 0.5 mg/m 2 to about 28 mg/m 2 for intravenous administration.

3. The method of claim 2 , wherein the dose of romidepsin ranges from about 8 mg/m 2 to about 14 mg/m 2 .

4. The method of claim 3 , comprising infusing the dose of romidepsin to the patient over a 4 hour period.

5. The method of claim 4 , comprising infusing the dose of romidepsin to the patient on days 1, 8 and 15 of a cycle.

6. The method of claim 5 , comprising repeating the cycle every 28 days.

7. The method of claim 1 , wherein the dose of romidepsin ranges from about 1 mg/m 2 to about 300 mg/m 2 for oral administration.

8. The method of claim 7 , wherein the dose of romidepsin ranges from about 25 mg/m 2 to about 75 mg/m 2 .

9. The method of claim 1 , wherein the DNA demethylating agent is 5-azacytidine.

10. A method for treating an MLL-rearranged infant ALL comprising administering to an MLL-rearranged infant ALL patient romidepsin in combination with a DNA demethylating agent, comprising intravenously infusing over a 4 hour period the romidepsin in a dose of 14 mg/m 2 to the patient on days 1, 8 and 15 of a cycle, wherein the cycle is repeated every 28 days.

11. The method of claim 10 , wherein the DNA demethylating agent is 5-azacytidine.

Assignments (3)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded May 9, 2013
From: ERASMUS MC - SOFIA CHILDREN'S HOSPITAL
To: CELGENE CORPORATION
Reel/Frame 030390/0797 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Apr 10, 2012
From: GLOUCESTER PHARMACEUTICALS, INC.
To: CELGENE CORPORATION
Reel/Frame 028020/0824 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Apr 10, 2012
From: STAM, RONALD; STUMPEL, DOMINIQUE J.P.M.
To: ERASMUS MC - SOFIA CHILDREN'S HOSPITAL
Reel/Frame 028021/0833 →
Continuity (2)
Provisional Application 61382459 · Sep 13, 2010
Related Publication 20120094927A1 · Apr 19, 2012