Granted Patent
B2
US 12,642,811 · App. 18/632,083 · Granted Jun 2, 2026
Treatment of hematological disorders
Assignee:
Jazz Pharmaceuticals Ireland Limited
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Abstract
The invention relates to compositions and methods for treating patients with hematological proliferative disorders with CPX-351, a liposomal composition of daunorubicin and cytarabine, and venetoclax.
Claims (25)
1 . A treatment cycle for treating a hematologic proliferative disorder in a subject, which treatment cycle comprises administering to the subject venetoclax and a pharmaceutical composition comprising CPX-351 that supplies daunorubicin and cytarabine at a fixed 1:5 molar ratio,
wherein the pharmaceutical composition is administered intravenously to the subject in a dosage of from 20 to 60 units/m 2 of CPX-351,
wherein the treatment cycle is 28 days,
wherein the subject achieves complete remission, or complete remission with incomplete neutrophil or platelet recovery after one to four treatment cycles, and
wherein the subject achieves Minimal Residual Disease negative status after one to four treatment cycles.
2 . The treatment cycle of claim 1 , wherein the pharmaceutical composition comprising CPX-351 is administered on days 1, 3, and 5 and venetoclax is administered orally on days 2-21.
3 . The treatment cycle of claim 1 , wherein the pharmaceutical composition comprising CPX-351 is administered on days 1 and 3 and venetoclax is administered orally on days 2-21.
4 . The treatment cycle of claim 1 , wherein the hematologic proliferative disorder is acute lymphocytic leukemia, acute myeloid leukemia, chronic myelogenous leukemia, chronic lymphocytic leukemia or acute promyelocytic leukemia, myelodysplastic syndrome or myeloproliferative neoplasm.
5 . The treatment cycle of claim 1 , wherein the hematologic proliferative disorder is acute myeloid leukemia.
6 . The treatment cycle of claim 1 , wherein the hematologic proliferative disorder is relapsed and/or refractory acute myeloid leukemia, de novo acute myeloid leukemia, therapy-related acute myeloid leukemia, newly diagnosed acute myeloid leukemia, or newly diagnosed secondary acute myeloid leukemia.
7 . The treatment cycle of claim 1 , wherein the subject has an Eastern Cooperative Oncology Group performance status of from 0 to 2.
8 . The treatment cycle of claim 1 , wherein the subject has an Eastern Cooperative Oncology Group performance status of from 0 to 1.
9 . The treatment cycle of claim 1 , wherein venetoclax is administered at a dosage of from 50 to 400 mg per day.
10 . The treatment cycle of claim 1 , wherein venetoclax is administered at a dosage of from 100 to 400 mg per day.
11 . The treatment cycle of claim 1 , wherein the pharmaceutical composition is administered intravenously in a dosage of 20 units/m 2 of CPX-351 on days 1 and 3 and venetoclax is administered orally on days 2-21.
12 . The treatment cycle of claim 1 , wherein the pharmaceutical composition is administered intravenously in a dosage of 30 units/m 2 of CPX-351 on days 1 and 3 and venetoclax is administered orally on days 2-21.
13 . The treatment cycle of claim 1 , wherein the pharmaceutical composition is administered intravenously in a dosage of 40 units/m 2 of CPX-351 on days 1 and 3 and venetoclax is administered orally on days 2-21.
14 . The treatment cycle of claim 1 , wherein the subject achieves complete remission, or complete remission with incomplete neutrophil or platelet recovery, and/or and Minimal Residual Disease negative status after one treatment cycle.
15 . The treatment cycle of claim 1 , wherein the pharmaceutical composition is administered intravenously in a dosage of from 20 to 40 units/m 2 of CPX-351 on days 1 and 3 and venetoclax is administered orally in a dosage of from 100 to 400 mg on days 2-21.
16 . The treatment cycle of claim 1 , wherein the pharmaceutical composition is administered intravenously in a dosage of from 40 to 60 units/m 2 of CPX-351 on days 1 and 3 and venetoclax is administered orally in a dosage of from 100 to 400 mg on days 2-21.
17 . The treatment cycle of claim 1 , wherein, prior to the administering, the subject is not in complete remission or complete remission with incomplete neutrophil or platelet recovery.
18 . A treatment cycle for treating a hematologic proliferative disorder in a subject, which treatment cycle comprises administering to the subject venetoclax and a pharmaceutical composition comprising CPX-351 that supplies daunorubicin and cytarabine at a fixed 1:5 molar ratio,
wherein the pharmaceutical composition is administered intravenously in a dosage of from 20 to 60 units/m 2 of CPX-351 on days 1 and 3 of a 28 day cycle, and
wherein, prior to the administering, the subject is not in complete remission or complete remission with incomplete neutrophil or platelet recovery.
19 . The treatment cycle of claim 18 , wherein the subject achieves complete remission, complete remission with incomplete neutrophil or platelet recovery, and/or Minimal Residual Disease negative status after one to four treatment cycles.
Assignments (5)
CORRECTIVE ASSIGNMENT TO CORRECT THE REMOVAL OF 8 PROPERTY NUMBERS PREVIOUSLY RECORDED AT REEL: 072341 FRAME: 0137. ASSIGNOR(S) HEREBY CONFIRMS THE CHANGE OF NAME.
Recorded Oct 8, 2025
From: CELATOR PHARMACEUTICALS, INC.
To: JAZZ PHARMACEUTICALS THERAPEUTICS, INC.
Reel/Frame 073058/0985 →
CHANGE OF NAME
Recorded Aug 7, 2025
From: CELATOR PHARMACEUTICALS, INC.
To: JAZZ PHARMACEUTICALS THERAPEUTICS, INC.
Reel/Frame 072341/0137 →
SECURITY AGREEMENT
Recorded Jul 29, 2025
From: CELATOR PHARMACEUTICALS, INC.; JAZZ PHARMACEUTICALS, INC.; JAZZ PHARMACEUTICALS IRELAND LIMITED; JAZZ PHARMACEUTICALS RESEARCH UK LIMITED (F/K/A GW RESEARCH LIMITED)
To: U.S. BANK TRUST COMPANY, NATIONAL ASSOCIATION, AS COLLATERAL TRUSTEE
Reel/Frame 072254/0795 →
ASSIGNMENT OF ASSIGNOR'S INTEREST
Recorded Jul 16, 2024
From: CHEUNG, RONALD; WANG, QI
To: JAZZ PHARMACEUTICALS IRELAND LIMITED
Reel/Frame 068000/0192 →
ASSIGNMENT OF ASSIGNOR'S INTEREST
Recorded Apr 10, 2024
From: FADERL, STEFAN
To: JAZZ PHARMACEUTICALS IRELAND LIMITED
Reel/Frame 067067/0233 →
Continuity (3)
Provisional Application
63115540
· Nov 18, 2020
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