# US 12,178,822 B2 · Methods of treating hematological malignancies using 2-(2,6-dioxopiperidin-3-yl)-4-((2-fluoro-4-((3-morpholinoazetidin-1-yl)methyl)benzyl)amino)isoindoline-1,3-dion

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- Number: US 12,178,822 B2
- Document ID: US12178822B2
- Status: Granted
- Kind: B2
- Application number: 18/315,404
- Filed: 2023-05-10
- Published: 2023-09-07
- Granted: 2024-12-31
- Earliest claimed: 2019-10-21
- Assignees: Celgene Corporation
- Applicants: Celgene Corporation
- Inventors: Maria Soraya Carrancio Anton; Tonia J. Buchholz; Shailaja Kasibhatla; Antonia Lopez-Girona; Rama Krishna Narla; Michael Pourdehnad
- Web page: https://patentgrep.com/patent/US12178822B2

## CPC

- A61K 31/5377: not condensed and containing further heterocyclic rings, e.g. timolol
- A61P 35/00: Antineoplastic agents
- A61K 9/0053: {Mouth and digestive tract, i.e. intraoral and peroral administration}
- 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

Provided herein are methods of using 2-(2,6-dioxopiperidin-3-yl)-4-((2-fluoro-4-((3-morpholinoazetidin-1-yl)methyl)benzyl)amino)isoindoline-1,3-dione, or an enantiomer, a mixture of enantiomers, a tautomer, an isotopolog, or a pharmaceutically acceptable salt thereof, for treating, preventing or managing hematological malignancies.

## Claims

### Claim 1

A method of treating a hematological malignancy, comprising administering to a subject in need thereof a therapeutically effective amount of Compound 1 of the formula:
or a tautomer, isotopolog, or pharmaceutically acceptable salt thereof, in one or more 7-day, 14-day, or 28-day treatment cycles, and wherein the hematological malignancy is marginal zone lymphoma (MZL), Burkitt lymphoma (BL), multiple myeloma (MM), myelodysplastic syndromes (MDS), acute myeloid leukemia (AML), acute lymphocytic leukemia (ALL), T-cell lymphoma (TCL), or Hodgkin's lymphoma (HL).

### Claim 2 (depends on 1)

The method of claim 1, wherein the hematological malignancy is marginal zone lymphoma.

### Claim 3 (depends on 2)

The method of claim 2, wherein the marginal zone lymphoma is splenic marginal zone lymphoma.

### Claim 4 (depends on 1)

The method of claim 1, wherein the hematological malignancy is Burkitt lymphoma.

### Claim 5 (depends on 1)

The method of claim 1, wherein the hematological malignancy is multiple myeloma.

### Claim 6 (depends on 5)

The method of claim 5, wherein the multiple myeloma is plasma cell leukemia.

### Claim 7 (depends on 1)

The method of claim 1, wherein the hematological malignancy is myelodysplastic syndromes.

### Claim 8 (depends on 1)

The method of claim 1, wherein the hematological malignancy is acute myeloid leukemia.

### Claim 9 (depends on 8)

The method of claim 8, wherein the acute myeloid leukemia is B-cell acute myeloid leukemia.

### Claim 10 (depends on 1)

The method of claim 1, wherein the hematological malignancy is acute lymphocytic leukemia.

### Claim 11 (depends on 1)

The method of claim 1, wherein the hematological malignancy is T-cell lymphoma.

### Claim 12 (depends on 11)

The method of claim 11, wherein the T-cell lymphoma is anaplastic large cell lymphoma.

### Claim 13 (depends on 11)

The method of claim 11, wherein the T-cell lymphoma is Sezary Syndrome.

### Claim 14 (depends on 1)

The method of claim 1, wherein the hematological malignancy is Hodgkin's lymphoma.

### Claim 15 (depends on 1)

The method of claim 1, wherein the hematological malignancy is relapsed or refractory.

### Claim 16 (depends on 1)

The method of claim 1, wherein the hematological malignancy is newly diagnosed.

### Claim 17 (depends on 1)

The method of claim 1, wherein the compound is administered orally.

### Claim 18 (depends on 1)

The method of claim 1, comprising administering Compound 1 of the formula:

### Claim 19 (depends on 1)

The method of claim 1, comprising administering a pharmaceutically acceptable salt of Compound 1 of the formula:

### Claim 20 (depends on 1)

The method of claim 1, wherein the compound is administered on days 1 to 5 of a 7-day cycle.

### Claim 21 (depends on 1)

The method of claim 1, wherein the compound is administered on days 1 to 3 of a 7-day cycle.

### Claim 22 (depends on 1)

The method of claim 1, wherein the compound is administered on days 1 to 7 of a 14-day cycle.

### Claim 23 (depends on 1)

The method of claim 1, wherein the compound is administered on days 1 to 10 of a 14-day cycle.

### Claim 24 (depends on 1)

The method of claim 1, wherein the compound is administered on days 1 to 21 of a 28-day cycle.

### Claim 25 (depends on 1)

The method of claim 1, wherein the compound is administered on days 1 to 5, days 8 to 12, days 15 to 19, and days 22 to 26 of a 28-day cycle.

### Claim 26 (depends on 1)

The method of claim 1, wherein the compound is administered on days 1 to 10 and days 15 to 24 of a 28-day cycle.