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Combination drug for treating leukemia and application of combination drug in preparation of drug for treating acute myeloid leukemia

An acute myeloid and leukemia technology, applied in the field of medicine, can solve relapse and refractory problems, and achieve the effect of solving relapse and refractory problems

Pending Publication Date: 2019-07-09
SHENZHEN CHIPSCREEN BIOSCIENCES CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0008] In view of this, the object of the present invention is to provide a new combination drug for the treatment of leukemia and its use in the preparation of drugs for the treatment of acute myeloid leukemia, the combination drug provided by the invention can solve the existing AML Relapse and Refractory Problems of Combination Chemotherapy

Method used

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  • Combination drug for treating leukemia and application of combination drug in preparation of drug for treating acute myeloid leukemia
  • Combination drug for treating leukemia and application of combination drug in preparation of drug for treating acute myeloid leukemia
  • Combination drug for treating leukemia and application of combination drug in preparation of drug for treating acute myeloid leukemia

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0037] Example 1: Clinical trial of Chidamide combined with DCAG in the treatment of acute myeloid leukemia

[0038] 1.1 Test drugs

[0039] Cidabenamide tablets (produced by Shenzhen Microchip Biotechnology Co., Ltd.), decitabine for injection (produced by Lunan Pharmaceutical Group Co., Ltd.), aclamycin for injection, cytarabine for injection, and Recombinant human granulocyte stimulating factor injection (purchased from hospital pharmacy, no fixed supplier).

[0040] 1.2 Test method

[0041] Number of cases: 100 cases in total;

[0042] standard constrain:

[0043] 1) Between the ages of 18-59, there is no limit to men or women;

[0044] 2) AML patients (non-AML-M3) diagnosed according to the 2008 World Health Organization (WHO) diagnostic criteria for myeloid malignancies;

[0045] 3) Patients who have undergone at least one systemic treatment (including chemotherapy, hematopoietic stem cell transplantation, etc.) without remission or relapse after remission;

[0046] 4) The ECOG behav...

Embodiment 2

[0115] Example 2: Clinical trial of Chidamide combined with DCAG in the treatment of acute myeloid leukemia

[0116] 2.1 Test drugs, 2.2 Test methods are the same as those in Example 1.

[0117] 2.3 The clinical trial results of chidamide combined with DCAG in the treatment of acute myeloid leukemia are as follows:

[0118] This clinical trial has increased the number of evaluable cases to 93 on the basis of Example 1. The results are as follows:

[0119] Clinical trial results: the overall number of evaluable persons (n=93), of which 24 cases achieved complete remission, the CR rate was 26% (24 / 93, 95% confidence interval [CI]: 16.9–34.7%), and 19 cases achieved complete remission. Remission with incomplete recovery of peripheral blood (CRi for short), the CRi rate was 20% (19 / 93, 95% CI: 12.2-28.4%), and the objective total effective rate was 46% (95% CI: 36.1-56.4%), The clinical trial results are shown in Table 5.

[0120] Table 5: Clinical trial results *

[0121]

[0122] * The t...

Embodiment 3

[0125] Example 3: Combined pharmaceutical composition

[0126] The combined pharmaceutical composition of this embodiment contains the following effective doses of active ingredients:

[0127] Chidamide 180mg, Decitabine 20mg / m 2 , Aclarithromycin 10mg / m 2 , Cytarabine 100mg / m 2 And granulocyte colony stimulating factor 300ug / day.

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Abstract

The invention relates to the field of medicine, in particular to a combination drug for treating leukemia. The drug comprises chidamide and DCAG medicine which are used for administration simultaneously, respectively or successively and have an effective dose, and the DCAG medicine is a combining drug of decitabine, cytarabinem, aclarubicin and granulocyte colony-stimulating factors. The inventionprovides the application of chidamide-combined DCAG in the preparation of a drug for treating the acute myeloid leukemia, and the combination drug has the following beneficial effects: the recurrentrefractory problem of an existing AML-combined chemotherapy scheme is solved, the complete remission (CR) of patients suffering from recurrent refractory acute myeloid leukemia which is treated by thecombination drug is up to 43.6%, and the objective remission rate (ORR) is up to 58.2%.

Description

[0001] This application requires that it be submitted to the Chinese Patent Office on December 29, 2017, the application number is 201711485562.X, and the name of the invention is "a combination drug for the treatment of leukemia and its use in the preparation of a drug for the treatment of acute myeloid leukemia The priority of the Chinese patent application of ", the entire content of which is incorporated into this application by reference. Technical field [0002] The present invention relates to the field of medicine, and in particular to a combined drug for the treatment of leukemia and its use in the preparation of a drug for the treatment of acute myeloid leukemia, specifically chidamide combined with other drugs in preparation for the treatment of acute myeloid leukemia Use in medicines for myeloid leukemia and combined medicines. Background technique [0003] Leukemia (commonly known as blood cancer) is a type of malignant clonal disease of hematopoietic stem cells, whic...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/4406A61K38/19A61K31/704A61K31/7068A61K31/706A61P35/02
CPCA61K31/4406A61K31/704A61K31/706A61K31/7068A61K38/193A61P35/02A61K2300/00
Inventor 鲁先平于力王立新付鑫
Owner SHENZHEN CHIPSCREEN BIOSCIENCES CO LTD
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