ITMCTR2200005965招募中未知
Clinical study on Rabdosia rubescens combined with medicine in the treatment of elderly MDS / AML and its relationship with DNMT3A R882 mutation
适应症
试验速览
- 阶段
- 未知
- 状态
- 招募中
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional study
入排标准
- 年龄范围
- 60 至 85（—）
- 性别
- All
入选标准
- •1. For patients with acute myeloid leukemia and myelodysplastic syndrome other than acute promyelocytic leukemia diagnosed by bone marrow cell morphology, immunology, genetics and molecular biology, the classification diagnosis shall refer to the diagnostic classification standard of the World Health Organization (who) in 2008. Specific requirements are as follows:
- •1) Peripheral blood or bone marrow primordial cells of acute leukemia = 20%,
- •2) AML with a previous history of MDS or with multilineage morbid hematopoiesis;
- •3) There is cytogenetic inheritance related to MDS and no specific genetic abnormalities of AML with recurrent cytogenetic abnormalities
- •4) MDS that meets the WHO standard and meets the treatment standard;
- •5) All the above patients need to have second-generation sequencing results
- •6) Chronic myelomonocytic leukemia (CMML)
- •2. Age = 60, male or female.
- •3. Not suitable for routine and intensive therapy; No chance of hematopoietic stem cell transplantation (regardless of objective and subjective factors)
- •4. The ECOG-ps score is 0-3.
- •5. Pass the requirements of the following laboratory test indicators (within 7 days before treatment):
- •1) Total bilirubin = (in the same age group) 1.5 times the upper limit of normal value;
- •2) AST and alt = (in the same age group) are 2.5 times the upper limit of normal value;
- •3) Serum creatinine clearance rate > 30ml / min;
- •4) Myocardial enzyme < 2 times the upper limit of normal value (in the same age group);
- •5) The ejection fraction measured by cardiac ultrasound (echo) was within the normal range.
排除标准
- •1) APL and AML with reproducible genetic abnormalities were included in those who diagnostic criteria.
- •2) Suitable for routine or intensive chemotherapy, with evidence of allogeneic hematopoietic stem cell transplantation.
- •3) Patients with treatment-related AML, other tumors are still active or have received radiotherapy and chemotherapy for other tumors within 6 months.
- •4) The World Health Organization (who) classification of AML is a subclass of AML not otherwise classified. Patients with acute myeloproliferative disease with bone marrow fibrosis and myelosarcoma.
- •5) AML / MDS with FLT3 or idh2 mutation intends to add corresponding inhibitors.
- •6) MDS patients with 5q-, or sf3b1 mutation alone.
- •7) serious infectious diseases (uncured tuberculosis and pulmonary aspergillosis).
- •8) AIDS patients.
- •9) There was evidence of central nervous system infiltration when AML was diagnosed.
- •10) Epilepsy, dementia and other mental disorders requiring drug treatment who cannot understand or comply with the study protocol.
- •11) Drug abuse, medical, psychological or social conditions that may interfere with the subject's participation in the study or the evaluation of the results of the study.
- •12) AML patients who voluntarily applied Bcl-2 inhibitor venekla and other targeted drugs.
- •13) The researchers considered it unsuitable for inclusion.
- •1) APL and AML with reproducible genetic abnormalities were included in those who diagnostic criteria.
- •2) Suitable for routine or intensive chemotherapy, with evidence of allogeneic hematopoietic stem cell transplantation.
- •3) Patients with treatment-related AML, other tumors are still active or have received radiotherapy and chemotherapy for other tumors within 6 months.
- •4) The World Health Organization (who) classification of AML is a subclass of AML not otherwise classified. Patients with acute myeloproliferative disease with bone marrow fibrosis and myelosarcoma.
- •5) AML / MDS with FLT3 or idh2 mutation intends to add corresponding inhibitors.
- •6) MDS patients with 5q-, or sf3b1 mutation alone.
- •7) serious infectious diseases (uncured tuberculosis and pulmonary aspergillosis).
- •8) AIDS patients.
- •9) There was evidence of central nervous system infiltration when AML was diagnosed.
- •10) Epilepsy, dementia and other mental disorders requiring drug treatment who cannot understand or comply with the study protocol.
- •11) Drug abuse, medical, psychological or social conditions that may interfere with the subject's participation in the study or the evaluation of the results of the study.
- •12) AML patients who voluntarily applied Bcl-2 inhibitor venekla and other targeted drugs.
- •13) The researchers considered it unsuitable for inclusion.
研究者
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