Application of chidamide combined with R-CHOP and combined medicine

A technology of R-CHOP and Chidamide, which is applied in the field of medicine, can solve the problems of poor therapeutic effect, shortened overall survival of DEL patients, and low complete remission rate, etc., and achieve significant curative effect

Active Publication Date: 2020-05-26
SHENZHEN CHIPSCREEN BIOSCIENCES CO LTD +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Conventional regimens are less effective in treating DEL
Studies have shown that after R-CHOP regimen treatment, the complete remission rate (CR) rate of DEL patients was significantly lower than that of non-DEL patients (66% vs. 84%, p<0.001), and the overall survival (OS) and Progression-free survival (PFS) was significantly shorter than non-DEL patients (5-year OS rate: 36% vs. 71%, p<0.05; 5-year PFS rate: 32% vs. 65%, p<0.05), therefore, On the basis of the standard first-line regimen of R-CHOP, it is an unmet clinical need to explore effective and relatively safe new drug combinations for DEL patients in DLBCL

Method used

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  • Application of chidamide combined with R-CHOP and combined medicine
  • Application of chidamide combined with R-CHOP and combined medicine
  • Application of chidamide combined with R-CHOP and combined medicine

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0016] Example 1: A prospective, single-arm, open-label phase II study of chidamide combined with R-CHOP regimen in the treatment of newly diagnosed, elderly, high-risk diffuse large B-cell lymphoma

[0017] Test drug: chidamide tablets: off-white tablets, 5mg / tablet. Produced by Shenzhen Microchip Biotechnology Co., Ltd. R-CHOP combined with chemotherapy drugs: rituximab (R) combined with cyclophosphamide (CTX), doxorubicin or epirubicin (ADR / EPI), vincristine (VCR), prednisone (Pred) .

[0018] Number of cases: A total of 49 patients are planned to be enrolled in this clinical trial.

[0019] Inclusion criteria: Patients must meet all of the following criteria to be enrolled.

[0020] 1. Histopathological diagnosis of diffuse large B-cell lymphoma, and CD20 positive;

[0021] 2. Age ≥ 61 years old, ≤ 75 years old;

[0022] 3. ECOG physical status score is 0, 1 or 2 points;

[0023] 4. No previous history of malignant tumors; no other tumors occurred at the same time; ...

Embodiment 2

[0054] Example 2: Clinical observation of R-CHOP combined with chidamide in the treatment of newly diagnosed diffuse large B-cell lymphoma with dual expression of MYC / BCL2

[0055] Test drug: chidamide tablets: off-white tablets, 5mg / tablet. Produced by Shenzhen Microchip Biotechnology Co., Ltd. R-CHOP combined with chemotherapy drugs: rituximab (R) combined with cyclophosphamide (CTX), doxorubicin (ADM), vincristine (VCR), and prednisone (Pred).

[0056] treatment solutions:

[0057] The name and dose of the research drug, this study is a single-group test, and the patient uses the administration method in Table 2:

[0058] Table 2

[0059] Drug Name dose Method of administration Medication time R 375mg / m 2

IV bolus day 0 CTX 750mg / m 2

IV bolus Day 1 ADM 50mg / m 2

IV bolus Day 1 VCR 1.4mg / m 2

IV bolus Day 1 Pred 60mg / m 2

oral Day 1-5 Chidamide 20mg / d oral Day 1, 4, 8, 11 ...

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Abstract

The invention relates to the technical field of medicines, and discloses an application of chidamide combined with R-CHOP and a combined medicine. The invention provides the application of a treatmentscheme of combining chidamide with R-CHOP, which has the synergistic treatment effect on B-cell lymphoma. The clinical tests prove that the effect of treating diffuse large B-cell lymphoma by combining chidamide with the R-CHOP scheme is better than that of the R-CHOP scheme, and the application can treat B-cell lymphoma patients more efficiently.

Description

[0001] This application claims the priority of the Chinese patent application submitted to the China Patent Office on November 20, 2018, with the application number 201811394614.7 and the title of the invention "Application of Chidamide Combined with R-CHOP and Combined Drugs", the entire content of which has been passed References are incorporated in this application. technical field [0002] The invention relates to the technical field of medicines, in particular to the application and combined medicine of chidamide combined with R-CHOP. Background technique [0003] B-cell lymphoma mainly includes diffuse large B-cell lymphoma (DLBCL), follicular lymphoma (FL), marginal zone B-cell lymphoma (MZL), and mantle cell lymphoma (MCL). Diffuse large B-cell lymphoma (DLBCL) is the most common type of non-Hodgkin's lymphoma (NHL), accounting for 31-34% of adult NHL in Europe and the United States, and generally >40% in Asian countries. The clinical course of DLBCL is aggressiv...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/4406A61K39/395A61K31/675A61K31/704A61K31/475A61K31/573A61P35/00
CPCA61K31/4406A61K39/39558A61K31/675A61K31/704A61K31/475A61K31/573A61P35/00A61K2300/00C07K16/2887A61K2039/505A61K39/3955A61K39/395A61P35/02A61K45/06
Inventor 鲁先平赵维莅付鑫许彭鹏刘霆
Owner SHENZHEN CHIPSCREEN BIOSCIENCES CO LTD
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