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Cytarabine With or Without VNP40101M in Treating Patients With Relapsed Acute Myeloid Leukemia

2013年11月5日 更新者：Vion Pharmaceuticals

A Phase III Randomized of Cloretazine™ (VNP40101M) and Cytosine Arabinoside (AraC) in Patients With Acute Myeloid Leukemia in First Relapse

RATIONALE: Drugs used in chemotherapy, such as cytarabine and VNP40101M, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells.

PURPOSE: This randomized phase III trial is studying cytarabine and VNP40101M to see how well they work compared to cytarabine alone in treating patients with relapsed acute myeloid leukemia.

研究概览

地位

完全的

条件

干预/治疗

详细说明

OBJECTIVES:

Primary

  • Compare the complete response (CR) and CR (with platelet count < 100,000/mm^3 but ≥ 20,000/mm^3 [transfusion independent for ≥ 7 consecutive days]) (CRp) rates in patients with acute myeloid leukemia in first relapse treated with cytarabine with vs without VNP40101M.

Secondary

  • Compare time to progression in patients treated with these regimens.
  • Compare duration of response in patients treated with these regimens.
  • Compare the survival of patients treated with these regimens.
  • Compare the toxicity of these regimens in these patients.

OUTLINE: This is a randomized, double-blind, placebo-controlled, parallel group, multicenter study. Patients are stratified according to age (< 60 years vs ≥ 60 years) and duration of first complete response (CR) or CR (with platelet count < 100,000/mm³ but ≥ 20,000/mm³ [transfusion independent for ≥ 7 consecutive days]) (CRp) (< 12 months vs ≥ 12 months).

  • Induction therapy: Patients are randomized to 1 of 2 treatment arms.

    • Arm I: Patients receive cytarabine IV continuously on days 1-3 and VNP40101M IV over 30-60 minutes on day 2 (at least 12 hours after the start of cytarabine).
    • Arm II: Patients receive cytarabine as in arm I and placebo IV over 30-60 minutes on day 2 (at least 12 hours after the start of cytarabine).

In both arms, patients demonstrating at least 20% reduction of blasts in bone marrow (based on total cellularity and percent blasts) after course 1 may receive 1 additional course of induction therapy between days 35-60 in the absence of disease progression or unacceptable toxicity. Patients achieving CR or CRp after 1 or 2 courses of induction therapy proceed to consolidation therapy.

  • Consolidation therapy: Beginning 6 weeks after initial documentation of CR or CRp, patients receive 1 course of consolidation therapy, as per induction therapy, according to their randomized treatment arm. These patients may then proceed to other consolidation, maintenance, and/or intensification therapy (including stem cell transplantation) off study at the discretion of the physician.

After completion of study treatment, patients are followed monthly for 6 months, every 2 months for 6 months, and then every 3 months for 2 years.

PROJECTED ACCRUAL: A total of 420 patients (280 in arm I and 140 in arm II) will be accrued for this study within 24-30 months.

研究类型

介入性

注册 (预期的)

420

阶段

  • 第三阶段

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

  • 加拿大
    • British Columbia
      • Vancouver、British Columbia、加拿大、V5Z 4E3
        • Vancouver Hospital and Health Science Center
    • New Brunswick
      • Saint John、New Brunswick、加拿大、E2L 4L2
        • Saint John Regional Hospital
    • Newfoundland and Labrador
      • St. John's、Newfoundland and Labrador、加拿大、A1B 3V6
        • Memorial University of Newfoundland
    • Nova Scotia
      • Halifax、Nova Scotia、加拿大、B3H 1V7
        • Capital District Health Authority Center for Clinical Research
    • Ontario
      • Ottawa、Ontario、加拿大、K1H 8L6
        • Ottawa Hospital Regional Cancer Centre - General Campus
      • Toronto、Ontario、加拿大、M5G 2M9
        • Princess Margaret Hospital
  • 塞尔维亚
      • Belgrade、塞尔维亚、11000
        • Clinical Centre of Serbia
      • Nis、塞尔维亚、18000
        • Clinical Centre Nis
      • Novi Sad、塞尔维亚、21000
        • Clinic Centre Novi Sad
  • 希腊
      • Athens、希腊、10676
        • Evaggelismos Hospital
      • Rio Patras、希腊、GR-26500
        • University of Patras Medical School
  • 德国
      • Berlin、德国、D-12200
        • Charite - Universitaetsmedizin Berlin - Campus Benjamin Franklin
      • Cologne、德国、D-50924
        • Medizinische Universitaetsklinik I at the University of Cologne
      • Frankfurt、德国、D-60596
        • Universitaetsfrauenklinik Frankfurt
      • Heidelberg、德国、D-69115
        • Universitatsklinikum Heidelberg
      • Muenster、德国、D-48149
        • Medizinische Klinik und Poliklinik A - Universitaetsklinikum Muenster
      • Munich、德国、D-81377
        • Klinikum der Universitaet Muenchen - Grosshadern Campus
      • Wurzburg、德国、D-97070
        • University Würzburg
  • 比利时
      • Brussels、比利时、1200
        • Cliniques universitaires Saint-Luc
      • Leuven、比利时、B-3000
        • U.Z. Gasthuisberg
      • Montigny-le-Tilleul、比利时、6110
        • CHU Charleroi - Site Vesale
  • 法国
      • Besancon、法国、25030
        • Centre Hospitalier Regional de Besancon - Hopital Jean Minjoz
      • Lyon、法国、69437
        • Hôpital Edouard Herriot
      • Marseille、法国、13273
        • Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes
      • Nantes、法国、44093
        • CHR Hotel Dieu
      • Pessac、法国、33604
        • Hopital Haut Lévêque
  • 波兰
      • Gdansk、波兰、80-211
        • Medical University of Gdańsk
      • Lodz、波兰、90-419
        • Medical University of Lodz
      • Lublin、波兰、20-954
        • Centrum Onkologii Ziemi Lubelskiez
      • Warsaw、波兰、00-957
        • Institute of Haematology and Blood Transfusion
      • Warsaw、波兰、00-909
        • Wojskowy Instytut Medyczny
  • 美国
    • California
      • Los Angeles、California、美国、90095-1781
        • Jonsson Comprehensive Cancer Center at UCLA
      • Los Angeles、California、美国、90089-9181
        • USC/Norris Comprehensive Cancer Center and Hospital
      • Orange、California、美国、92868
        • Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center
      • San Francisco、California、美国、94115
        • UCSF Comprehensive Cancer Center
    • Connecticut
      • Hartford、Connecticut、美国、06105
        • Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center
    • Florida
      • Miami、Florida、美国、33136
        • University of Miami Sylvester Comprehensive Cancer Center
      • Tampa、Florida、美国、33612
        • Veterans Affairs Medical Center - Tampa (Haley)
    • Illinois
      • Chicago、Illinois、美国、60637-1470
        • University of Chicago Cancer Research Center
      • Chicago、Illinois、美国、60611-3013
        • Robert H. Lurie Comprehensive Cancer Center at Northwestern University
    • Indiana
      • Indianapolis、Indiana、美国、46260
        • American Health Network - North Meridian
    • Maryland
      • Baltimore、Maryland、美国、21201
        • Greenebaum Cancer Center at University of Maryland Medical Center
    • Massachusetts
      • Boston、Massachusetts、美国、02115
        • Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
    • Nevada
      • Las Vegas、Nevada、美国、89135
        • Nevada Cancer Institute
    • New Mexico
      • Albuquerque、New Mexico、美国、87106
        • New Mexico Cancer Care Alliance
    • New York
      • Buffalo、New York、美国、14263-0001
        • Roswell Park Cancer Institute
      • Valhalla、New York、美国、10595
        • New York Medical College
    • North Carolina
      • Durham、North Carolina、美国、27710
        • Duke Comprehensive Cancer Center
      • Greenville、North Carolina、美国、27858
        • Brody School of Medicine at East Carolina University
    • Ohio
      • Columbus、Ohio、美国、43214-3998
        • Riverside Methodist Hospital Cancer Care
    • Pennsylvania
      • Hershey、Pennsylvania、美国、17033-0850
        • Penn State Cancer Institute at Milton S. Hershey Medical Center
      • Pittsburgh、Pennsylvania、美国、15224
        • Western Pennsylvania Cancer Institute at Western Pennsylvania Hospital
    • South Carolina
      • Charleston、South Carolina、美国、29425
        • Hollings Cancer Center at Medical University of South Carolina
    • Tennessee
      • Nashville、Tennessee、美国、37232-6838
        • Vanderbilt-Ingram Cancer Center
    • Texas
      • Houston、Texas、美国、77030-4009
        • M.D. Anderson Cancer Center at University of Texas
  • 英国
    • England
      • Birmingham、England、英国、B9 5SS
        • Birmingham Heartlands Hospital
      • Cambridge、England、英国、CB2 2QQ
        • Addenbrooke's Hospital at Cambridge University Hospitals NHS Foundation Trust
      • Leicester、England、英国、LE1 5WW
        • Leicester Royal Infirmary
      • London、England、英国、SE5 9RS
        • King's College Hospital
      • Manchester、England、英国、M13 9WL
        • Manchester Royal Infirmary
    • Wales
      • Cardiff、Wales、英国、CF14 4XW
        • University Hospital of Wales
  • 荷兰
      • Groningen、荷兰、9713 GZ
        • University Medical Center Groningen

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

DISEASE CHARACTERISTICS:

  • Histologically confirmed acute myeloid leukemia (AML)

    • Any WHO classification, excluding acute promyelocytic leukemia
    • At least 10% blasts by bone marrow aspirate and/or biopsy

  • In first relapse after achieving a first complete response (CR) OR CR (with platelet count < 100,000/mm³ but ≥ 20,000/mm³ [transfusion independent for ≥ 7 consecutive days]) (CRp) that lasted ≥ 3 months but ≤ 24 months after completion of the initial induction regimen

    • Relapse confirmed by recurrence of blasts in peripheral blood, bone marrow histopathology, and/or histologically confirmed CNS or extramedullary disease

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • ECOG 0-2

Life expectancy

  • Not specified

Hematopoietic

  • See Disease Characteristics

Hepatic

  • Bilirubin ≤ 1.5 times upper limit of normal (ULN)
  • AST ≤ 3 times ULN
  • Chronic hepatitis allowed

Renal

  • Creatinine ≤ 2.0 mg/dL

Cardiovascular

  • No myocardial infarction within the past 3 months
  • No uncontrolled arrhythmias
  • No uncontrolled congestive heart failure

Pulmonary

  • No severe chronic obstructive pulmonary disease
  • No requirement for supplemental oxygen at rest

Immunologic

  • No uncontrolled active infection

    • Infections that are controlled and under active treatment with antibiotics allowed
  • No evidence of invasive fungal infection by blood or tissue cultures

Other

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for 3 months after completion of study treatment
  • No clinical evidence of another active malignancy by tumor marker, pathology, or radiologic studies
  • No other severe medical condition that would preclude study treatment

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Not specified

Chemotherapy

  • At least 12 hours since prior hydroxyurea

Endocrine therapy

  • Not specified

Radiotherapy

  • Not specified

Surgery

  • Not specified

Other

  • No prior treatment while in first relapse except hydroxyurea
  • No other concurrent standard or investigational treatment for AML
  • No concurrent disulfiram (Antabuse®)

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：随机化
  • 屏蔽：双倍的

武器和干预

参与者组/臂
干预/治疗
实验性的：Induction therapy arm I
Patients receive cytarabine IV continuously on days 1-3 and VNP40101M IV over 30-60 minutes on day 2 (at least 12 hours after the start of cytarabine).
药品：阿糖胞苷
鉴于IV
药品：laromustine
Given IV
有源比较器：Induction therapy arm II
Patients receive cytarabine as in arm I and placebo IV over 30-60 minutes on day 2 (at least 12 hours after the start of cytarabine).
药品：阿糖胞苷
鉴于IV
其他：安慰剂
鉴于IV

研究衡量的是什么？

主要结果指标

结果测量
整体回复率

次要结果测量

结果测量
毒性
反应持续时间
总体反应
肿瘤进展时间

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

Vion Pharmaceuticals

调查人员

  • Bonny L. Johnson, RN, MSN、Vion 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

2005年3月1日

初级完成 (实际的)

2008年3月1日

研究完成 (实际的)

2008年3月1日

研究注册日期

首次提交

2005年6月2日

首先提交符合 QC 标准的

2005年6月2日

首次发布 (估计)

2005年6月3日

研究记录更新

最后更新发布 (估计)

2013年11月6日

上次提交的符合 QC 标准的更新

2013年11月5日

最后验证

2009年2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

  • CDR0000430677
  • VION-CLI-037

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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