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Application of combination of chidamide and CGB as well as autologous hematopoietic stem cells and drug combination

A technology of hematopoietic stem cells and chidamide, which is applied in the application of chidamide combined with CGB and autologous hematopoietic stem cells and the field of combined drugs, can solve the problems of doubts about curative effect, poor curative effect, and inability of patients to get disease improvement, and achieve efficient treatment Effect

Pending Publication Date: 2020-06-05
SHENZHEN CHIPSCREEN BIOSCIENCES CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Commonly used second-line regimens include those that have no cross-drug resistance with first-line regimens, have less impact on hematopoiesis, and do not affect subsequent stem cell collection, such as DICE, ICE, and GemOx regimens, for salvage treatment, but there are still a considerable number of patients who cannot get disease improvement
However, in the era when new drugs represented by MabThera participated in the treatment of lymphoma, the efficacy of relapsed and primary drug-resistant lymphoma patients receiving classic pretreatment chemotherapy such as BEAM regimen followed by autologous transplantation has been questioned
For example, the CORAL study showed that in patients with relapsed DLBCL treated with R-CHOP regimen, the curative effect of autologous transplantation after BEAM pretreatment was worse than that of relapsed patients treated with CHOP regimen
Moreover, if the duration of the first complete remission is less than 12 months, the IPI score at the time of relapse is greater than 1 point, and those who have received multiple treatment options and still have viable tumor residues before transplantation pretreatment, the effect of autologous transplantation is even worse

Method used

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  • Application of combination of chidamide and CGB as well as autologous hematopoietic stem cells and drug combination
  • Application of combination of chidamide and CGB as well as autologous hematopoietic stem cells and drug combination

Examples

Experimental program
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Embodiment 1

[0017] Example 1: Chidamide, cladribine, gemcitabine, and busulfan (ChiCGB) regimen combined with autologous hematopoietic stem cell transplantation in the treatment of relapsed or refractory diffuse large B-cell lymphoma in multicenter, single-arm, open-label II phase clinical trial

[0018] Test drug:

[0019] Chidamide tablets: off-white tablets, 5mg / tablet. Produced by Shenzhen Microchip Biotechnology Co., Ltd.

[0020] Cladribine: water injection, 10mg / bottle. Manufactured by Zhejiang Hisun Pharmaceutical Co., Ltd.

[0021] Gemcitabine: Use commercially available drugs.

[0022] Busulfan: water injection, 60mg / bottle. Produced by Otsuka Pharmaceutical Research and Development (Beijing) Co., Ltd.

[0023] Number of cases: A total of 93 patients are planned to be enrolled in this clinical trial.

[0024] Inclusion criteria: Patients must meet all of the following criteria to be enrolled.

[0025] 1. Diffuse large B-cell lymphoma who did not obtain CR in the first-li...

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Abstract

The invention relates to the technical field of drugs, and discloses application of a combination of chidamide and CGB as well as autologous hematopoietic stem cells and a drug combination. The invention provides application of a treatment scheme of the combination of the chidamide and CGB as well as autologous hematopoietic stem cell transplantation which have a synergistic treatment effect on Bcell lymphoma. Clinical trials verify that PFS and OS of the scheme of the combination of the chidamide and CGB as well as the autologous hematopoietic stem cell transplantation for treating relapsedor refractory diffuse large B cell lymphoma are 81.7% and 100% respectively. By the application, patients suffering from the B cell lymphoma can be treated efficiently.

Description

[0001] This application claims the priority of the Chinese patent application submitted to the China Patent Office on November 27, 2018, with the application number 201811427194.8, and the title of the invention is "Chidamide Combined with CGB and Autologous Hematopoietic Stem Cell Application and Combined Drugs", all of which The contents are incorporated by reference in this application. technical field [0002] The invention relates to the technical field of medicines, in particular to the application of chidamide combined with CGB and autologous hematopoietic stem cells and combined medicines. 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). The existing R-CHOP regimen of rituximab (R) combined with cyclophosphamide (CTX), doxorubicin (ADR), vincristine (VCR), and prednisone (Pred) is the current treatment for diffuse large B-...

Claims

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Application Information

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IPC IPC(8): A61K31/4406A61K31/7076A61K31/7068A61K31/255A61K35/28A61P35/00
CPCA61K31/4406A61K31/7076A61K31/7068A61K31/255A61K35/28A61P35/00A61K2300/00
Inventor 鲁先平刘霆季杰付鑫
Owner SHENZHEN CHIPSCREEN BIOSCIENCES CO LTD
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