Study of Molecular and Genetic Abnormalities in Patients With Myeloid Neoplasms
Evaluation of the Incidence and Prognostic Impact of Molecular and Genetic Abnormalities in Patients With Acute Myeloid Leukemia, Myelodysplastic Syndrome and Myeloproliferative Neoplasms
The objective of this study is to describe the prevalence and prognostic impact of the most common genetic abnormalities in patients with Myeloid Neoplasms, including Acute Myeloid Leukemia (AML), Myeloproliferative Neoplasms (MPN), Myelodysplastic Syndromes (MDS) and Myeloproliferative/Myelodysplastic Neoplasms. Patients will have samples of blood and/or bone marrow collected and sent to Hospital Israelita Albert Einstein for analysis and storage.
Patients with a diagnosis of Acute Myeloid Leukemia will be treated according to an uniform protocol.
研究概览
地位
研究类型
注册 (实际的)
阶段
- 阶段2
联系人和位置
学习地点
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SP
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Sao Paulo、SP、巴西、05651901
- Hospital israelita Albert Einstein
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Acute Myeloid Leukemia-Intensive Chemotherapy
Inclusion Criteria:
- Diagnosis of AML according to WHO criteria
- Age greater than 18 years
- Performance status (ECOG) between 0-2
- Adequate liver and kidney function
- Signed Informed Consent form
- No prior therapy for AML, except use of hydroxyurea for control of elevated white blood cell counts
- Adequate contraception for fertile men and women
- Eligible for intensive chemotherapy (as judged by the treating physician)
Exclusion Criteria:
- Acute myeloid leukemia with retinoic acid receptor alpha (RARA) translocations (APL, acute promyelocytic leukemia)
- Pregnant women
- HIV-positivity
- New York Heart Association class III and IV congestive heart failure
- Patient refuses to use adequate contraception
- History of hypersensibility to any of the used chemotherapy drugs
- Patient refuses to sign informed consent form
Acute Myeloid Leukemia-Non-Intensive Chemotherapy
Inclusion Criteria:
- Diagnosis of AML according to WHO criteria
- Age greater than 18 years
- Signed Informed Consent form
- No prior therapy for AML, except use of hydroxyurea for control of elevated white blood cell counts
- Adequate contraception for fertile men and women
- Non-eligible for intensive chemotherapy (as judged by the treating physician)
Exclusion Criteria:
- Acute myeloid leukemia with RARA translocations (APL, acute promyelocytic leukemia)
- Pregnant women
- HIV-positivity
- Patient refuses to use adequate contraception
- History of hypersensibility to any of the used chemotherapy drugs
- Patient refuses to sign informed consent form
Chronic Myeloid Disorders:
Inclusion Criteria:
- Diagnosis of Myeloproliferative Neoplasm or Myelodysplastic Syndrome or Myeloproliferative/Myelodysplastic Neoplasm according to WHO criteria
- Age greater than 18 years
- Signed Informed Consent form
Exclusion Criteria:
- Patient refuses to sign informed consent form
学习计划
研究是如何设计的?
设计细节
- 主要用途:基础科学
- 分配:非随机化
- 介入模型:并行分配
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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其他:AML-Intensive Chemotherapy
Patients with Acute Myeloid Leukemia fit for intensive chemotherapy Patients will receive Induction Chemotherapy, and CR will be evaluated after 28 days. Patients who achieve CR post-induction chemotherapy will receive post-remission therapy according to risk:
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Induction chemotherapy for patients with AML eligible for intensive chemotherapy:
其他名称:
Consolidation chemotherapy for patients eligible for intensive chemotherapy with low-risk AML or patients with intermediate-/high-risk AML who do not have matched donors: -Cytarabine 1.5 g/m2 IV in 3 hours days 1, 3 and 5 for 3 cycles
其他名称:
Autologous Stem Cell Transplantation for consolidation of patients eligible for intensive chemotherapy with low-risk AML or patients with intermediate-/high-risk AML who do not have matched donors:
其他名称:
Allogeneic Stem Cell Transplantation for consolidation of patients eligible for intensive chemotherapy with intermediate-/high-risk AML Conditioning regimen:
其他名称:
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其他:AML-Non-intensive chemotherapy
Patients with acute myeloid leukemia not fit for intensive chemotherapy Patients will receive induction chemotherapy with either low dose cytarabine or decitabine. Assignment to each drug will depend on drug availability and physician discretion. No randomization will be done between the drugs. Cycles will be repeated every 28 days. Patients who achieve CR will continue to post-consolidation therapy with either cytarabine or decitabine, based on the induction therapy received. Patients will receive a maximum of 4 cycles until achieving CR, if no response is seen after 4 cycles patients will be deemed refractory. |
Chemotherapy for patients with AML who are not fit for intensive chemotherapy:
其他名称:
Chemotherapy for patients with AML who are not fit for intensive chemotherapy:
其他名称:
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无干预:Chronic Myeloid Disorders
Patients with Chronic Myeloid Disorders:
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Prevalence of molecular and cytogenetic abnormalities
大体时间:2 years
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As assessed by results of molecular and cytogenetic tests and frequency in the population studied
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2 years
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Overall survival
大体时间:5 years
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Evaluation of 5-years overall survival in patients with Acute Myeloid Leukemia, Myeloproliferative Neoplasms, Myelodysplastic Syndromes and Myeloproliferative/Myelodysplastic Neoplasms
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5 years
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Response rate
大体时间:1 month
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Evaluate complete remission (CR) rate at 1 month for patients with Acute Myeloid Leukemia who received induction chemotherapy.
Complete remission was defined by the presence of < 5% blasts in the bone marrow (BM) with > 1 x 10^9/L neutrophils and >100x10^9/L platelets in the peripheral blood (PB)
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1 month
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Disease Free Survival
大体时间:5 years
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Evaluate rate of 5-years disease-free survival in patients with Acute Myeloid Leukemia who enter complete remission after induction chemotherapy
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5 years
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Cumulative incidence of relapse and non-relapse mortality
大体时间:5 years
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Evaluate 5-years cumulative incidence of relapse and non-relapse mortality in patients with Acute Myeloid Leukemia who achieve complete remission following induction chemotherapy
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5 years
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Number of participants with adverse events as a measure of safety and tolerability
大体时间:1 year
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Evaluate hematological and non-hematological toxicity in patients with Acute Myeloid Leukemia treated according to the protocol.
Toxicity will be graded as per the National Cancer Institute Common Toxicity Criteria for Adverse Events v4.0.3
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1 year
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Cumulative Incidence of Transformation to Acute Myeloid Leukemia
大体时间:5 years
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Evaluate 5-years incidence of transformation to Acute Myeloid Leukemia in patients with Myeloproliferative Neoplasms, Myelodysplastic Syndromes and Myeloproliferative/Myelodysplastic Neoplasms
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5 years
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合作者和调查者
调查人员
- 研究主任:Fabio P Santos, MD、Hospital israelita Albert Einstein
- 学习椅:Nelson Hamerschlak, MD, PhD、Hospital israelita Albert Einstein
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
关键字
其他相关的 MeSH 术语
其他研究编号
- LMA Brasil
- 11/1714 (其他标识符:HIAE CEP)
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