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Clofarabine and Temsirolimus in Treating Older Patients With Relapsed or Refractory Acute Myeloid Leukemia (AML1107)

2017年10月10日更新者：Gruppo Italiano Malattie EMatologiche dell'Adulto

An Open Label Phase II Trial of Clofarabine and Temsirolimus in Older Patients With Relapsed or Refractory Acute Myeloid Leukemia (AML)

RATIONALE: Drugs used in chemotherapy, such as clofarabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Temsirolimus may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving clofarabine together with temsirolimus may kill more cancer cells.

PURPOSE: This phase II trial is studying how well giving clofarabine together with temsirolimus works in treating older patients with relapsed or refractory acute myeloid leukemia.

研究概览

地位

完全的

条件

白血病

干预/治疗

详细说明

OBJECTIVES:

Primary

To determine the complete response rate in older patients with relapsed or refractory acute myeloid leukemia when treated with low-dose clofarabine and temsirolimus.

Secondary

To determine the tolerability and safety of this regimen.
To determine the duration of response.
To determine the duration of survival.

OUTLINE: This is a multicenter study.

Induction therapy: Patients receive clofarabine IV over 1 hour on days 1-5 and temsirolimus IV over 30 minutes on days 1, 8, and 15. Treatment continues for 1-2 courses in the absence of disease progression or unacceptable toxicity.
Maintenance therapy: Patients achieving morphologic complete remission (CR) or CR with incomplete blood count recovery receive temsirolimus IV over 30 minutes on days 1 and 8 of each month. Treatment continues for 12 months in the absence of disease progression or unacceptable toxicity.

研究类型

介入性

注册 (实际的)

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。

学习地点

意大利
- - Ancona、意大利
    - Azienda Ospedaliera Nuovo Ospedale "Torrette"
  - Bari、意大利
    - Azienda Ospedaliero-Universitaria Policlinico Consorziale
  - Bologna、意大利、40138
    - Azienda Ospedaliera Di Bologna Policlinico S. Orsola - Malpighi
  - Catania、意大利、95124
    - Ospedale Ferrarotto
  - Catanzaro、意大利、88100
    - Ospedale Regionale A. Pugliese
  - Napoli、意大利
    - Azienda Ospedaliera Universitaria - Università degli Studi di Napoli "Federico II" - Facoltà di Medicina e Chirurgia
  - Napoli、意大利
    - Azienda Ospedaliera di Rilievo Nazionale "A. Cardarelli"
  - Novara、意大利
    - S.C.D.U. Ematologia - DIMECS e Dipartimento Oncologico - Università del Piemonte Orientale Amedeo Avogadro
  - Orbassano、意大利
    - A.O. Universitaria S. Luigi Gonzaga Di Orbassano
  - Parma、意大利
    - Azienda Ospedaliero - Universitaria Di Parma
  - Pescara、意大利、61100
    - Azienda ASL di Pescara
  - Roma、意大利
    - Università degli Studi "Sapienza" - Dip Biotecnologie Cellulari ed Ematologia - Divisione di Ematologia
  - Roma、意大利
    - Complesso Ospedaliero S. Giovanni Addolorata
  - Roma、意大利
    - Ospedale S. Eugenio
  - Roma、意大利
    - S.C. di Ematologia e Trapianti - I.F.O. Istituto Nazionale Tumori Regina Elena
  - Rome、意大利、00168
    - Policlinico A. Gemelli - Universita Cattolica del Sacro Cuore
  - Rome、意大利、00133
    - Policlinico Di Tor Vergata
  - Sassari、意大利
    - Serv. di Ematologia Ist. di Ematologia ed Endocrinologia
  - Verona、意大利、37134
    - Policlinico G. B. Rossi - Borgo Roma

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

60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:

Cytologically confirmed acute myeloid leukemia (AML) meeting the following criteria:
- At least 20% of blasts in the bone marrow
- AML in first relapse OR refractory to no more than one prior combination of intensive chemotherapy induction regimen
No acute promyelocytic leukemia
No blast transformation of chronic myeloid leukemia or other myeloproliferative disorders
No active CNS leukemia

PATIENT CHARACTERISTICS:

WHO performance status 0-2
Life expectancy ≥ 4 weeks
Serum total bilirubin ≤ 1.5 times upper limit of normal (ULN)*
AST and ALT ≤ 2.5 times ULN*
Serum creatinine ≤ 1.0 mg/dL* OR estimated glomerular filtration rate > 60 mL/min
No active uncontrolled systemic infection
No concurrent active malignancy
No HIV positivity
No severe concurrent medical condition or psychiatric disorder that would preclude study participation NOTE: *Unless due to organ leukemic involvement

PRIOR CONCURRENT THERAPY:

See Disease Characteristics
More than 2 weeks since prior myelosuppressive chemotherapy
At least 48 hours since prior hydroxyurea
No prior clofarabine or temsirolimus
No prior allogeneic stem cell transplantation
No investigational drug within the past 30 days

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：非随机化
介入模型：单组作业
屏蔽：无（打开标签）

研究衡量的是什么？

主要结果指标

结果测量	大体时间
Complete Response Rate 大体时间：At 2 years from study entry	At 2 years from study entry

次要结果测量

结果测量	措施说明	大体时间
Number of Serious Adverse Events Within 2 Years 大体时间：At 2 years from study entry		At 2 years from study entry
Duration of Response 大体时间：At 2 years from study entry	Participants who responded to treatment	At 2 years from study entry
Duration of Survival 大体时间：At 2 years from study entry		At 2 years from study entry

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

Gruppo Italiano Malattie EMatologiche dell'Adulto

调查人员

首席研究员：Sergio Amadori, MD、Ospedale Sant' Eugenio

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

2008年12月1日

初级完成 (实际的)

2012年6月1日

研究完成 (实际的)

2013年10月23日

研究注册日期

首次提交

2008年10月17日

首先提交符合 QC 标准的