Lymphoma Clinical Trial
Official title:
A Prospective Study of Low-dose Decitabine Combined With COP Regimen in the Treatment of Relapsed and Refractory DLBCL
Decitabine is a cytosine analogue and is a specific DNA methyltransferase (DNMT) inhibitor. It directly inhibits DNMT by phosphorylating DNA and inhibits DNMT, thereby reversing DNA methylation and inducing tumor cells to Normal cell differentiation or induction of tumor cell apoptosis.Diffuse large B-cell lymphoma (DLBCL) is the most common pathological type in non-Hodgkin's lymphoma. The first-line chemotherapy regimen using Rituximab+Cyclophosphamide+Doxorubicin +Vincristine+Bonisone(R-CHOP)significantly increases the remission rate and disease-free survival of patients with DLBCL, but it is difficult to partially relapse. Long-term remission and survival rates in treating patients are not satisfactory.Due to the greater cardiac toxicity of adriamycin, more patients can not be uncomfortable, so the COP program is also widely used in patients with DLBCL, and achieved a good response rate.In 2008, the FDA had approved decitabine for the demethylation treatment of Myelodysplastic syndrome(MDS). Over the years, good initial remission rates and better long-term survival rates have been achieved in patients with MDS.There are also a variety of clinical trials of decitabine for patients with solid tumors that have achieved significant clinical efficacy.Due to the high side effects of high-dose decitabine, patient tolerance is poor. Therefore, the purpose of this study was to evaluate the efficacy and safety of low-dose decitabine combined with Cyclophosphamide+Vindesine+Bonisone(COP) regimen (D-COP) 4-6 course of treatment for relapsed and refractory diffuse large B-cell lymphoma.
Decitabine is a cytosine analogue and is a specific DNA methyltransferase (DNMT) inhibitor.
It directly inhibits DNMT by phosphorylating DNA and inhibits DNMT, thereby reversing DNA
methylation and inducing tumor cells to Normal cell differentiation or induction of tumor
cell apoptosis. High concentrations of decitabine inhibit DNA synthesis, exert its cytotoxic
effects, and induce cell death; low concentrations of decitabine inactivate DNMT and
demethylate some hypermethylated CpG islands in tumor suppressor genes. To activate the
silencing tumor suppressor gene and exert its effect of inhibiting tumor growth to achieve
anti-tumor effects.
Epigenetics plays an important role in the occurrence and development of tumors and is a hot
topic in recent years. Methylation of DNA is the main form of epigenetic information. Normal
methylation plays an important role in maintaining the normal functions of cells and organs
and in the development, differentiation, growth, and aging of the body. However, the abnormal
participation of cell epigenetics can directly affect the overexpression of tumor cells,
which leads to the occurrence and development of tumor cells.
Diffuse large B-cell lymphoma (DLBCL) is the most common pathological type in non-Hodgkin's
lymphoma. The first-line chemotherapy regimen using R-CHOP significantly increases the
remission rate and disease-free survival of patients with DLBCL, but it is difficult to
partially relapse. Long-term remission and survival rates in treating patients are not
satisfactory.Due to the greater cardiac toxicity of adriamycin, more patients can not be
uncomfortable, so the COP program is also widely used in patients with DLBCL, and achieved a
good response rate.In 2008, the FDA had approved decitabine for the demethylation treatment
of MDS. Over the years, good initial remission rates and better long-term survival rates have
been achieved in patients with MDS.There are also a variety of clinical trials of decitabine
for patients with solid tumors that have achieved significant clinical efficacy.Due to the
high side effects of high-dose decitabine, patient tolerance is poor. Therefore, the purpose
of this study was to evaluate the efficacy and safety of low-dose decitabine combined with
COP regimen (D-COP) 4-6 course of treatment for relapsed and refractory diffuse large B-cell
lymphoma.
In summary, this study will select relapsed refractory high-risk patients, previous studies
have confirmed that the COP program can make a good effect in most patients, also confirmed
the demethylation of decitabine in other tumors Therefore, whether the treatment of low-dose
decitabine combined with COP regimen for DLBCL can improve the prognosis is worth looking
forward to. At present, there are few researches on the treatment of DLBCL with low-dose
decitabine at home and abroad. The purpose of this study is to explore whether low-dose
decitabine combined with COP regimen as a treatment for patients with relapsed and refractory
DLBCL can improve the relapse-refractory DLBCL. The patient's prognosis, and hope to explore
through a stratified analysis which group of patients benefit more from it.
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