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Fludarabine Combined With Either Alemtuzumab or Rituximab in Treating Patients With Refractory or Relapsed B-Cell Chronic Lymphocytic Leukemia

2013年8月1日更新者：Bayer

Phase II Trial Comparing Combination Treatment With Fludarabine and Alemtuzumab to Fludarabine and Rituximab in Patients With B-Cell Chronic Lymphocytic Leukemia Requiring Treatment After First Line Therapy

RATIONALE: Drugs used in chemotherapy, such as fludarabine, work in different ways to stop cancer cells from dividing so they stop growing or die. Monoclonal antibodies, such as alemtuzumab and rituximab, can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Combining chemotherapy with monoclonal antibody therapy may kill more cancer cells. It is not yet known whether fludarabine is more effective when combined with alemtuzumab or with rituximab in treating chronic lymphocytic leukemia.

PURPOSE: Randomized phase II trial to compare the effectiveness of combining fludarabine with either alemtuzumab or rituximab in treating patients who have refractory or relapsed B-cell chronic lymphocytic 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

Compare the complete response rate in patients with refractory or relapsed B-cell chronic lymphocytic leukemia treated with fludarabine and alemtuzumab vs fludarabine and rituximab.

Secondary

Compare the overall response rate in patients treated with these regimens.
Compare 1-year survival of patients treated with these regimens.
Compare time to progression in patients treated with these regimens.
Compare duration of response in patients treated with these regimens.
Compare the adverse event profile of these regimens in these patients.
Compare the molecular response rate in patients treated with these regimens.
Compare lymphocyte and lymphocyte subset recovery (CD3, CD3/CD4, CD3/CD8, CD20) in patients treated with these regimens.
Compare the time to complete response in patients treated with these regimens.
Compare the rate of cytomegalovirus reactivation and time to reactivation in patients treated with these regimens.

OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified according to prior treatment with fludarabine (yes vs no). Patients are randomized to 1 of 2 treatment arms.

Arm I: Patients receive fludarabine IV over 30 minutes on days 1-5. At least 30 minutes before fludarabine administration, patients receive alemtuzumab subcutaneously (SC) on days 1-5.
Arm II: Patients receive fludarabine as in arm I. At least 30 minutes before fludarabine administration, patients receive rituximab IV on days 1 and 4 of course 1 and on day 1 only in subsequent courses.

In both arms, treatment repeats every 28 days for 4-6 courses in the absence of disease progression or unacceptable toxicity. An interim assessment is performed during course 4. Patients achieving a partial response or stable disease receive 2 additional courses of therapy (for a total of 6 courses). Patients achieving a complete response (CR) do not receive further treatment beyond CR.

Patients are followed weekly for 2 months, monthly for 6 months, every 2 months for 6 months, and then every 6 months for 1 year.

PROJECTED ACCRUAL: A total of 150 patients (75 per treatment arm) will be accrued for this study.

研究类型

介入性

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

美国
- Massachusetts
  - Boston、Massachusetts、美国、02115
    - Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
- Mississippi
  - Jackson、Mississippi、美国、39202
    - Jackson Oncology Associates, PLLC
- New Jersey
  - New Brunswick、New Jersey、美国、08903
    - Cancer Institute of New Jersey at Robert Wood Johnson University Hospital
- Pennsylvania
  - Pittsburgh、Pennsylvania、美国、15224
    - Western Pennsylvania Cancer Institute
  - Pittsburgh、Pennsylvania、美国、15232
    - Hillman Cancer Center at University of Pittsburgh Cancer Institute

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:

Diagnosis of B-cell chronic lymphocytic leukemia (CLL), defined as:
- Peripheral lymphocyte count > 5,000/mm^3
- Clonal CD5-, CD19-, and CD23-positive lymphocytes
Refractory to OR relapsed after prior first-line therapy
No CNS involvement with CLL

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)
Hepatitis B surface antigen negative
Hepatitis C antibody negative

Renal

Creatinine ≤ 1.5 times ULN

Immunologic

No active cytomegalovirus
No prior fludarabine-associated autoimmune hemolytic anemia or immune thrombocytopenic purpura
No active infection requiring treatment with antibiotic, antiviral, or antifungal agents
No prior significant allergic reaction to antibody therapies that required therapy to be discontinued
HIV negative

Other

No active secondary malignancy
No other concurrent severe diseases or mental disorders
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy

More than 4 weeks since prior alemtuzumab and/or rituximab
No prior bone marrow transplantation
No concurrent thrombopoietin or pegfilgrastim

Chemotherapy

More than 3 weeks since prior fludarabine

Endocrine therapy

Not specified

Radiotherapy

Not specified

Surgery

Not specified

Other

More than 3 months since prior investigational drugs
No other concurrent cytotoxic therapy

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：无（打开标签）

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

Bayer

调查人员

学习椅：Ann S. LaCasce, MD、Dana-Farber Cancer Institute

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

2003年7月1日

初级完成 (实际的)

2005年6月1日

研究完成 (实际的)

2009年10月1日

研究注册日期

首次提交

2004年7月8日

首先提交符合 QC 标准的

2004年7月9日

首次发布 (估计)

2004年7月12日

研究记录更新

最后更新发布 (估计)

2013年8月2日

上次提交的符合 QC 标准的更新

2013年8月1日

最后验证