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CMR Rate of Newly Diagnosed CML-CP Patients Treated With Nilotinib (MACS1428)

2016年1月11日 更新者：Novartis Pharmaceuticals

A Single-arm, Open-label, Multi-center Study of Complete Molecular Response (CMR) in Adult Patients With Newly Diagnosed Philadelphia Chromosome Positive (Ph+) Chronic Myelogenous Leukemia in Chronic Phase (CML-CP)

"This is a single-arm, open-label, multi-center study of complete molecular response (CMR) in adult patients with newly diagnosed Philadelphia chromosome positive (Ph+) chronic myelogenous leukemia in chronic phase (CML-CP). The study is designed to evaluate early and deep molecular responses up to 4 years on nilotinib treatment. The primary end point is Rate of confirmed CMR in newly diagnosed Philadelphia chromosome positive CML-CP patients."

研究概览

地位

完全的

条件

干预/治疗

研究类型

介入性

注册 (实际的)

128

阶段

  • 第四阶段

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。

学习地点

  • 美国
    • California
      • Anaheim、California、美国、92801
        • Pacific Cancer Medical Center, Inc.
      • Burbank、California、美国、91505-6866
        • Providence St. Joseph Medical Center Roy&Patricia Disney Fam Cancer
      • Concord、California、美国、94520
        • Bay Area Cancer Research Dept.ofBayAreaCancerResearch
      • Yorba Linda、California、美国、92886
        • St. Jude Heritage Medical Group Virginia Crosson Cancer Center
    • Florida
      • Jacksonville、Florida、美国、32256
        • Sarah Cannon Research Institute SCRI
      • Miami、Florida、美国、33176
        • Advanced Medical Specialties
      • New Port Richey、Florida、美国、34652
        • Pasco Hernando Oncology
    • Georgia
      • Augusta、Georgia、美国、30912
        • Georgia Regents University MedCollege of GA Cancer Ctr 2
    • Illinois
      • Chicago、Illinois、美国、60640
        • Louis A. Weiss Memorial Hospital
      • Chicago、Illinois、美国、60612
        • Stroger Cook County Hospital Division of Hematology & Onc
    • Indiana
      • Beach Grove、Indiana、美国、46107
        • Indiana Blood and Marrow Institute
    • Kansas
      • Witchita、Kansas、美国、67214-3728
        • Cancer Center of Kansas
    • Louisiana
      • New Orleans、Louisiana、美国、70115
        • LSU HEALTH SCIENCES CENTER/ LSU SCHOOL OF MEDICINE Feist-Weiller Cancer Center(3)
    • Maryland
      • Baltimore、Maryland、美国、21201
        • University of Maryland
    • Massachusetts
      • Boston、Massachusetts、美国、02115
        • Dana Farber Cancer Institute
    • Michigan
      • Detroit、Michigan、美国、48202
        • Henry Ford Hospital
    • Missouri
      • St. Louis、Missouri、美国、63110
        • St. Louis University Cancer Center
    • Nebraska
      • Omaha、Nebraska、美国、68198
        • University of Nebraska Medical Center University of Nebraska Med Ctr
    • New Jersey
      • Hackensack、New Jersey、美国、07601
        • Hackensack University Medical Center Dept.of HackensackUniv.MedCtr.
    • New York
      • Bronx、New York、美国、10467
        • Montefiore Medical Center
      • Rochester、New York、美国、14642
        • University of Rochester Medical Ct James P Wilmot Cancer Ctr
    • North Carolina
      • Durham、North Carolina、美国、27710
        • Duke University Medical Center Duke University Med Ctr
    • Oregon
      • Portland、Oregon、美国、97201
        • Oregon Health & Science University
    • South Carolina
      • Greenville、South Carolina、美国、29605
        • Cancer Centers of the Carolinas Cancer Center
    • Tennessee
      • Chattanooga、Tennessee、美国、37404
        • Chattanooga Oncology and Hematology Assoicates, PC Chattanooga Oncology
      • Germantown、Tennessee、美国、38138
        • The Jones Clinic
      • Nashville、Tennessee、美国、37203
        • Tennessee Oncology Sarah Cannon Research Inst.
    • Texas
      • Dallas、Texas、美国、75204
        • Baylor Research Institute Baylor Research Institute (17)
      • Houston、Texas、美国、77090
        • Millennium Oncology
      • Houston、Texas、美国、77024
        • Oncology Consultants Oncology Consultants, P.A.
    • Virginia
      • Charlottesville、Virginia、美国、22908
        • University of Virginia
    • Washington
      • Everett、Washington、美国、98201
        • Providence Regional Cancer Partnership

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:

Patients with Ph+ CML-CP within 3 months of diagnosis. Male or female patients' ≥ 18 years of age. Patients must have adequate end organ function.

Exclusion Criteria:

Previously documented T315I mutation. Other CML treatment is an exclusion criteria with the following exception: While awaiting study start, patients may be treated with anagrelide (no treatment duration limit), hydroxyurea (no treatment duration limit), and/or up to a 14 day supply of a tyrosine kinase inhibitor (TKI) approved by the FDA for frontline treatment. Patients taking a TKI prior to study entry must have at least a one day washout from their last dose of medication and have recovered from any side effects of such therapy.

Impaired cardiac function as defined by the protocol. Patients with contraindications to receiving nilotinib, including concomitant medications.

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：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：Nilotinib
Participants received 300 mg twice daily (b.i.d.). Dose increases to 400 b.i.d. were permitted, per Investigator's discretion.
药品：Nilotinib
Nilotinib was supplied as 150 mg and 200 mg hard gelatin capsules.

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
Number of Participants With Confirmed Complete Molecular Response (CMR)
大体时间：4 years
CMR was defined as at least 4.5 log reduction of breakpoint cluster region gene/Abelson proto-oncogene (Bcr-Abl) transcipts from the standardized baseline on the international scale (equivalent to Bcr-Abl <=0.0032% IS) with a minimum of 25,614 ABL control copies. CMR was to be confirmed by a second polymerase chain reaction (PCR) sample drawn 3 months later where the results should be less than or equal to 0.0032% with a minimum of 25,614 Abelson proto-oncogene (ABL) control copies.
4 years

次要结果测量

结果测量
措施说明
大体时间
Number of Participants With Complete Cytogenetic Response (CCyR) and Major Molecular Response (MMR)
大体时间：4 years

CCyR was defined as 0% Philadelphia chromosome-positive (Ph+) metaphases in the bone marrow. MMR was defined as a 3 log reduction of Bcr-Abl transcripts from the standardized baseline on the international scale (equivalent to Bcr-Abl ≤ 0.1% IS).

Bcr-Abl transcripts assessed by peripheral blood quatitative real time polymerase chain reaction (RQ-PCR) were used for the determination of all molecular responses.
4 years
Time to CMR, CCyR and MMR
大体时间：4 years
Time to CMR, CCyR, and MMR was defined as the time from the date of enrollment to the date of first documented CMR, CCyR and MMR, respectively.
4 years
Duration of CMR, CCyR and MMR
大体时间：4 years
Duration of CMR, CCyR and MMR were defined as the time from the first date of achievement of the response to the date of first documented loss of the response.
4 years
Number of Participants With Progression to Accelerated Phase/Blastic Crisis (AP/BC)
大体时间：4 years
Progression to AP/BC is defined as loss of CCyR, MMR, and CMR and was summarized by frequencies and percentages.
4 years
Time to Progression of AP/BC
大体时间：4 years
Time to progression of AP/BC was defined as the time from the date of the first dose of study drug to the date of first documented progression of AP/BC.
4 years
Number of Participants With Loss of CCyR, MMR and CMR
大体时间：4 years
Rate of loss of CMR was defined as an increase in the Bcr-Abl transcripts to greater than 0.0032% IS. Rate of loss of CCyR was defined as an increase in the Ph+ bone marrow cells to greater than 0%. Rate of loss of MMR was defined as an increase in the Bcr-Abl transcripts to greater than 0.1% IS.
4 years
Number of Participants With CMR Who Were Dosed to 400 mg b.i.d.
大体时间：4 years
CMR was defined as at least 4.5 log reduction of breakpoint cluster region gene/Abelson proto-oncogene (Bcr-Abl) transcipts from the standardized baseline on the international scale (equivalent to Bcr-Abl <=0.0032% IS) with a minimum of 25,614 ABL control copies. CMR was to be confirmed by a second polymerase chain reaction (PCR) sample drawn 3 months later where the results should be less than or equal to 0.0032% with a minimum of 25,614 Abelson proto-oncogene (ABL) control copies.
4 years
Event-free Survival, Progression-free Survival and Overall Survival
大体时间：4 years
Event-free survival was defined as the time from the date of enrollment to the date of first occurrence of any of the following: loss of Complete Hematological Response (CHR), loss of CCyR, loss of Partial Cytogenetic Response (PCyR), progression to the accelerated phase or blast crisis, and death from any cause. Progression-free survival was defined as the time from the date of enrollment to the date of first occurrence of any of the following: progression to the accelerated phase or blast crisis, death, and loss of CMR. Overall survival was defined as the time from the date of enrollment until death due to any cause.
4 years

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。

赞助

Novartis Pharmaceuticals

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。

一般刊物

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

2010年11月1日

初级完成 (实际的)

2014年11月1日

研究完成 (实际的)

2014年11月1日

研究注册日期

首次提交

2010年10月21日

首先提交符合 QC 标准的

2010年10月21日

首次发布 (估计)

2010年10月25日

研究记录更新

最后更新发布 (估计)

2016年2月8日

上次提交的符合 QC 标准的更新

2016年1月11日

最后验证

2016年1月1日

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

  • CAMN107AUS28

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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