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急性髓样白血病(AML)治疗期间的监测,排毒和重新平衡金属,这是一项2期随机研究

2026年10月5日 更新者:M.D. Anderson Cancer Center

The goal of this clinical research study is to learn if metal detoxification (with calcium disodium edetate [Ca-EDTA] and dimercaptosuccinic acid [DMSA]) during standard therapy can help improve outcomes in patients with intermediate-risk, high-risk, or secondary AML compared to standard therapy alone. Researchers think lowering the level of metals found in the blood/bone marrow may help to control the disease and/or improve the response to chemotherapy.

研究概览

详细说明

Primary Objective:

To compare event free survival of patients with newly diagnosed (or untreated) secondary, intermediate, and high-risk AML or newly diagnosed MPN-BP (including CML-BP) receiving metal detoxification during standard therapy to patients with newly diagnosed (or untreated) secondary, intermediate, and high-risk AML or newly diagnosed MPN-BP (including CML-BP) receiving standard therapy alone.

Secondary Objectives:

Compare the remission rates and overall survival rates of patients with newly diagnosed (or untreated) secondary, intermediate, and high-risk AML and newly diagnosed MPN-BP (including CML-BP) receiving metal detoxification during standard therapy to those receiving standard therapy alone.

  • To assess the efficacy information regarding the combined therapy in terms of the overall response rate (ORR) including CR, CRh, CRi, MLFS, and PR in patients with newly diagnosed (or untreated) secondary, intermediate, and high-risk AML and newly diagnosed MPN-BP (including CML-BP) receiving metal detoxification during standard therapy and in patients with secondary, intermediate and high-risk AML and newly diagnosed MPN-BP (including CML-BP) receiving standard therapy alone.
  • To compare adverse events of patients with newly diagnosed (or untreated) secondary, intermediate, and high-risk AML and newly diagnosed MPN-BP (including CML-BP) receiving metal detoxification during standard therapy to patients with newly diagnosed (or untreated), secondary, intermediate, and high-risk AML and newly diagnosed MPN-BP (including CML-BP) receiving standard therapy alone.
  • To assess the complete remission (CR), complete remission with incomplete hematologic recovery (CRi), Complete Remission with Partial hematological recovery (CRh), partial remission (PR), hematologic improvement (HI), morphologic leukemia free state (MLFS) rates, and the overall survival (OS) in AML and MPN-BP patients undergoing cancer therapy combined with DMSA and Ca-EDTA and in patients receiving cancer therapy alone.
  • To assess overall survival and event free survival in AML and MPN-BP patients undergoing cancer therapy combined with DMSA and Ca-EDTA and in patients receiving AML therapy alone To assess remission duration in AML and MPN-BP patients undergoing cancer therapy combined with DMSA and Ca-EDTA and in patients receiving AML therapy alone.
  • To monitor toxic and essential metal levels during AML therapy combined with DMSA and Ca-EDTA and to evaluate the reduction in metals in the bone marrow and blood of newly diagnosed AML patients undergoing metal detoxification combined with standard AML therapy.
  • Correlate metal and copper isotopic abundance ratios of AML patients with clinical data, conventional cytogenetics, extensive Next Generation Sequencing (NGS) (300-gene panel), exposure survey data, and clinical outcome data, and to perform a larger analysis by pooling this data with metal/genomic/survey/outcome data obtained on 2017-0752, 2017-0937 and PA15-0302.
  • To assess other responses of interest in Measurement of Effect Section

研究类型

介入性

注册 (估计的)

140

阶段

  • 阶段2

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

学习地点

    • Texas
      • Houston、Texas、美国、77030
        • 招聘中
        • The University of Texas M. D. Anderson Cancer Center
        • 首席研究员:
          • Maro Ohanian, DO
        • 接触:

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  1. Understand and voluntarily sign an informed consent form for participants 18 years or older, unless LAR signs where applicable along with any required verbal assents if patients can provide assent.

  2. Age 18 years or older at the time of signing the informed consent form.

  3. Diagnosis of Any of the Following:

    • Newly diagnosed (or untreated) AML or Newly diagnosed Myeloproliferative Neoplasm in Myeloid Blast Phase (MPN-BP) [including Chronic Myeloid Leukemia in Blast Phase (CML-BP)], Ph+AML with intermediate-risk or high-risk (by ELN), or any other intermediate or high-risk AML by ELN
    • Secondary AML regardless of ELN risk status, however, may not have CBF [t(8;21) or inv(16)]

    Secondary AML types include:

    • Secondary AML evolved from prior untreated MDS, myeloproliferative neoplasm (MPN), or Aplastic Anemia
    • Therapy-related AML (t-AML)
    • AML evolved after prior MDS, MPN, or Aplastic Anemia after prior therapy for those myeloid bone marrow disorders
    • Secondary AML, including blast phase of MPN (MPN-BP) [also, including CML in blast phase (BP of CML) after prior hematologic myeloid bone marrow disease (MDS, MPN, Aplastic Anemia, CML) (patients may have received treatment for their prior hematologic disorder for their previous bone marrow disorder) . Newly diagnosed (or untreated) myeloid blast phase of MPN (including myeloid blast phase of CML)/Ph+AML.150
  4. Patients can enroll on this study after start of non-investigational induction therapy but must be within first 2 cycles of front-line therapy, as long as not in a complete remission.

  5. Transformed and untreated AML transformed from previously treated MDS, myeloproliferative neoplasm (MPN) or other types of secondary AML are allowed. Myeloid-Blast Phase of MPN and Myeloid Blast Phase of Chronic Myeloid Leukemia (CML) are allowed/Ph+ AML are allowed.

  6. Eastern Cooperative Oncology Group (ECOG) performance status of . 2

  7. Laboratory test results within these ranges (unless due to leukemia or other hematologic malignancy):

    • Serum creatinine.2.0 mg/dL
    • Total Bilirubin . 2.0 x Upper limit of normal (ULN) unless the patient has Gilbert fs.
    • AST (SGOT) and/or ALT (SGPT) . 2.0 x ULN
  8. Women of childbearing potential (WCBP) must have a negative urine or serum pregnancy test within 14 days and must either commit to continued abstinence from heterosexual intercourse or adopting at least one highly effective method of contraception. These methods include intra-uterine device, tubal ligation, partners vasectomy, and hormonal birth control pills. Men must agree not to father a child and agree to use a condom if his partner is of childbearing potential.

  9. Extramedullary disease is allowed if it can be measured and followed for response.

Exclusion Criteria:

  1. Nursing and pregnant individuals. Should a study participant become pregnant or suspect pregnancy while participating in this study, the study participant should inform their treating physician immediately.
  2. Uncontrolled inter-current illness including, but not limited to, uncontrolled active infection, symptomatic congestive heart failure, unstable angina pectoris, or psychiatric illness/social situations that would limit compliance with study requirements or which judged by the investigator, places the patient at unacceptable risk.
  3. Acute Promyelocytic leukemia (APL)
  4. Prior venetoclax failure

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:支持治疗
  • 分配:不适用
  • 介入模型:单组作业
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
实验性的:Metal Detoxification with DMSA + Ca-EDTA with Standard AML Therapy

Participants treatment will be administered on either an inpatient or outpatient basis

Given PO

Given by IV

Given by infusion

Given PO

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
Safety and Adverse Events (AEs)
大体时间:Through study completion; an average of 1 year

Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0

Through study completion; an average of 1 year

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Maro Ohanian, DO、M.D. Anderson Cancer Center

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2025年5月8日

初级完成 (估计的)

2029年8月31日

研究完成 (估计的)

2031年8月31日

研究注册日期

首次提交

2025年1月31日

首先提交符合 QC 标准的

2025年1月31日

首次发布 (实际的)

2025年2月6日

研究记录更新

最后更新发布 (实际的)

2026年10月6日

上次提交的符合 QC 标准的更新

2026年10月5日

最后验证

2026年10月1日

更多信息

与本研究相关的术语

其他研究编号

  • 2024-1369
  • NCI-2025-00860 (其他标识符:NCI-CTRP Clinical Trials Registry)
  • CDMRP-TX230317 (其他标识符:Congressionally Directed Medical Research Programs)

药物和器械信息、研究文件

研究美国 FDA 监管的药品

是的

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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