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Purpose of mitoxantrone hydrochloride liposome for treating non-hodgkin lymphoma

A liposome, lymphoma technology, applied in the field of anti-tumor

Inactive Publication Date: 2020-01-21
CSPC ZHONGQI PHARM TECH (SHIJIAZHUANG) CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0041] In the prior art, there is no disclosure about mitoxantrone or mitoxantrone liposome alone for the treatment of refractory and relapsed aggressive NHL, especially DLBCL and PTCL

Method used

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  • Purpose of mitoxantrone hydrochloride liposome for treating non-hodgkin lymphoma
  • Purpose of mitoxantrone hydrochloride liposome for treating non-hodgkin lymphoma
  • Purpose of mitoxantrone hydrochloride liposome for treating non-hodgkin lymphoma

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0057] Embodiment 1 Mitoxantrone liposome is used alone to treat DLBCL

[0058] standard constrain:

[0059]Our company has conducted a phase II clinical study of mitoxantrone liposomes in the treatment of DLBCL and peripheral T / NK cell lymphoma. The inclusion criteria for this study are as follows:

[0060] 1) Volunteer to be tested and sign the informed consent form;

[0061] 2) Aged 18-75 years old, gender is not limited;

[0062] 3) ECOG score 0-2;

[0063] 4) Expected survival time ≥ 3 months;

[0064] 5) Non-Hodgkin's lymphoma with diffuse large B cells and peripheral T / NK cells confirmed by histopathology, and peripheral T / NK cell lymphoma is limited to the following types: Peripheral T-cell lymphoma (not specified) , angioimmunoblastic T-cell lymphoma, ALK+ systemic anaplastic large T-cell lymphoma, ALK-systemic anaplastic large T-cell lymphoma, extranodal NK / T-cell lymphoma, nasal type, enteropathy-associated T-cell lymphoma tumor, primary hepatosplenic γδT-cell ...

Embodiment 2

[0086] Example 2 The adverse reaction analysis of mitoxantrone liposome used alone in the treatment of DLBCL:

[0087] Security Analysis:

[0088] Analyzing the adverse reactions of the above-mentioned DLBCL subjects, the highest incidence of adverse reactions was hematological toxicity.

[0089] In terms of hematological toxicity, 31.4% of the subjects experienced grade 3 or higher white blood cell count reduction, 28.6% of the subjects experienced grade 3 or higher neutropenia, and 5.7% of the subjects experienced grade 3 or higher thrombocytopenia. This is much lower than the hematological toxicity recorded in the literature (Cancer Sci January 2007, vol.98) analyzed in the background technology (in this study, 18 cases (60%) had 3-4 grade hematological toxicity. 8 cases (27%) had grade 4 neutropenia despite the use of leukocyte-raising drugs (G-CSF). Five patients (16.7%) had grade 3-4 thrombocytopenia). Among the non-hematological toxicities, 5.7% of the subjects had gr...

Embodiment 3

[0090] Embodiment 3 Mitoxantrone liposome is used alone to treat PTCL

[0091] The inclusion criteria, administration method, safety and curative effect evaluation are the same as in Example 1.

[0092] The mitoxantrone liposome developed by our company is positioned as the second-line treatment in the treatment of PTCL. The ORR of this product in clinical research is 53.8%, which is comparable to the currently recommended second-line HDAC inhibitors, including pralatrexate and romidepsin. Compared with HDAC inhibitors, belinostat and chidamide (HDAC inhibitors are oral preparations, administered once a day, ORR is lower than 30%), it is much higher than that of HDAC inhibitors. Patients who achieve remission in a short period of time can undergo bone marrow transplantation in time.

[0093] Mitoxantrone liposome is an injection, the dosage is 14, 16, 20mg / m 2 or 24mg / m 2 , administered once every 28 days. Subjects received an average of 3.6±1.8 cycles of treatment.

[00...

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Abstract

The invention relates to the field of anti-tumor, and discloses a purpose of a mitoxantrone liposome preparation for preparation of medicine for treating a lymphoma, wherein the lymphoma is preferablya non-hodgkin lymphoma, is further preferably an invasive non-hodgkin lymphoma, is more further preferably a recurrent and refractory invasive lymphoma, and is more further preferably a diffuse largeB cell lymphoma or a peripheral T-cell lymphoma. The mitoxantrone liposome preparation is singly used, and is not applied in a way of being combined with other anti-tumor medicine.

Description

[0001] Cross references to related patent applications [0002] This patent application refers to Chinese patent application 200610102339.8 filed on December 29, 2006 and PCT application WO2008 / 080367A1 filed on December 29, 2007, the disclosures of which are hereby incorporated by reference in their entirety. technical field [0003] The invention belongs to the field of anti-tumor, and specifically relates to the application of mitoxantrone liposome in treating diffuse large B-cell lymphoma and peripheral T-cell lymphoma. Background technique [0004] 1. Disease Background [0005] Malignant lymphoma (ML) is a general term for a large group of complex malignant tumors of the lymphoid hematopoietic system, which can be divided into two categories: Hodgkin's lymphoma (HL) and non-Hodgkin's lymphoma (NHL). [0006] NHL is a group of heterogeneous lymphoproliferative malignant lymphomas with different clinical manifestations and treatment responses. According to the speed of...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/127A61K31/136A61P35/00
CPCA61K9/1271A61K31/136A61P35/00A61K9/0019A61K9/127
Inventor 李春雷彭悦颖娄坤王雅鹃汪玉梅陈珊孟志宾薛健飞原静罗红梅姚雪坤王世霞
Owner CSPC ZHONGQI PHARM TECH (SHIJIAZHUANG) CO LTD
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