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临床试验/NCT00040690
NCT00040690已完成2 期

A Clinicopathological Study In Burkitts's And Burkitt-Like Non-Hodgkin's Lymphoma

Medical Research Council1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2008年11月1日最近更新:
适应症
相关药物

试验速览

阶段
2 期
状态
已完成
入组人数
120
试验地点
1
主要终点
Progression-free survival

研究概览

简要总结

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating patients who have Burkitt's lymphoma or Burkitt's leukemia.

详细描述

OBJECTIVES:

  • Describe the morphology, phenotype, and cytogenetics, using fresh tumor tissue (when possible), in patients with Burkitt's or Burkitt-like lymphoma/leukemia treated with the CODOX-M chemotherapy regimen (cyclophosphamide, vincristine, doxorubicin, and methotrexate) alone or alternating with the IVAC chemotherapy regimen (ifosfamide, etoposide, and cytarabine).
  • Determine whether cytogenetic and molecular changes are associated with or predictable from the immunophenotype of the tumor cells or patient characteristics (e.g., age).
  • Examine the relationship between t(14;18) and bcl-2 expression in patients treated with this regimen.
  • Determine whether the presence of specific cytogenetic and molecular changes, in particular the presence of t(14;18) and t(8;14), is associated with an adverse outcome (progression-free and overall survival) in patients treated with this regimen.
  • Assess the activity of the alternating CODOX-M/IVAC chemotherapy regimens using a lower dose of methotrexate (compared to the UKLG LY06 trial) in these patients.
  • Assess further the activity of these regimens in patients with leukemic Burkitt's lymphoma.
  • Modify the chemotherapy doses in these regimens to include older patients who are often excluded from clinical trials.

OUTLINE: This is a multicenter study. Patients with low-risk disease are assigned to group A, while patients with high-risk disease are assigned to group B.

Group A (low-risk group):

  • Patients receive 3 courses of the CODOX-M chemotherapy regimen comprising cyclophosphamide IV on days 1-5, vincristine IV on days 1 and 8, doxorubicin IV on day 1, and methotrexate (MTX) IV over 24 hours on day 10. Patients over age 65 receive reduced-dose MTX on day 10. All patients receive leucovorin calcium (CF) IV once at hour 36 after initiation of MTX infusion, once every 3 hours between hours 36-48, and continuing once every 6 hours until blood levels of MTX are safe. Patients also receive filgrastim (G-CSF) subcutaneously (SC) once daily beginning on day 13 and continuing until blood counts recover.
  • During all 3 courses of the CODOX-M regimen, patients receive CNS prophylaxis comprising cytarabine (ARA-C) intrathecally (IT) on days 1 and 3, MTX IT on day 15, and oral CF (24 hours after IT MTX) on day 16.

研究设计

研究类型
Interventional
主要目的
Treatment
盲法
None

入排标准

年龄范围
16 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •DISEASE CHARACTERISTICS:
  • •Diagnosis of diffuse B-cell lymphoma in a nodal or an extranodal site
  • •CD20 and CD79 positive
  • •100% expression of Ki67 (MIB1) in all of the tumor cells OR
  • •Diagnosis of bone marrow replacement/leukemia comprising mature B-cell lymphoma
  • •sIg and CD19 positive
  • •CD34 and Tdt negative
  • •Patients in the low-risk group must meet at least 3 of the following criteria:
  • •Normal lactate dehydrogenase (LDH) level
  • •WHO performance status 0-1
  • •Ann Arbor stage I or II
  • •No more than 1 extranodal site (e.g., bone marrow, gastrointestinal tract, or CNS)
  • •Patients in the high-risk group must meet at least 2 of the following criteria:
  • •Raised LDH level
  • •WHO performance status 2-4
  • •Ann Arbor stage III or IV
  • •More than 1 extranodal site
  • •PATIENT CHARACTERISTICS:
  • •16 and over
  • •Performance status:
  • •See Disease Characteristics
  • •Life expectancy:
  • •Not specified
  • •Hematopoietic:
  • •See Disease Characteristics
  • •See Disease Characteristics
  • •Not specified
  • •No mental or physical status that would preclude study
  • •No other disease or prior malignancy that would preclude study
  • •HIV negative
  • •Not pregnant
  • •Negative pregnancy test
  • •Fertile patients must use effective contraception
  • •PRIOR CONCURRENT THERAPY:
  • •Biologic therapy:
  • •Not specified
  • •Chemotherapy:
  • •No prior chemotherapy except 1 course of preinduction chemotherapy (e.g., CHOP [cyclophosphamide, doxorubicin, vincristine, and prednisone] or a related regimen)
  • •Endocrine therapy:
  • •Not specified
  • •Radiotherapy:
  • •No prior radiotherapy
  • •Not specified

排除标准

  • 未提供

结局指标

主要结局

Progression-free survival

次要结局

  • Survival time

研究者

申办方类型
Other Gov

研究点 (1)

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