NCT00238368已完成2 期
Autologous Blood or Marrow Transplantation for Aggressive Non-Hodgkin's Lymphoma Based on Early [18F] FDG-PET Scanning
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins1 个研究点 分布在 1 个国家目标入组 59 人开始时间: 2004年2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
- 59
- 试验地点
- 1
- 主要终点
- 2-year event free survival
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy 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. Giving chemotherapy with an autologous stem cell or bone marrow transplant may allow more chemotherapy to be given so that more cancer cells are killed. Procedures, such as fludeoxyglucose F 18 positron emission tomography (FDG-PET) (done during chemotherapy) may help doctors predict a patient's risk of relapse and help plan the best treatment.
PURPOSE: This phase II trial is studying how well FDG-PET works in predicting risk of relapse in patients with aggressive non-Hodgkin's lymphoma who are undergoing combination chemotherapy with or without autologous stem cell or bone marrow transplant.
详细描述
OBJECTIVES:
Primary
- Determine event-free survival of patients with aggressive non-Hodgkin's lymphoma treated with early high-dose therapy and autologous peripheral blood stem cell (PBSC) or bone marrow transplantation (BMT) based on positive fludeoxyglucose F 18 positron emission tomography (FDG-PET) results obtained during first-line chemotherapy.
- Compare event-free survival of patients treated with this regimen with historical event-free survival of patients with positive FDG-PET results obtained during first-line chemotherapy that are not treated with early high-dose therapy.
Secondary
- Compare overall survival of patients treated with a standard treatment regimen vs early high-dose therapy and autologous PBSC or BMT based on FDG-PET results obtained during first-line chemotherapy.
- Determine the predictive value of an early negative FDG-PET result in these patients.
- Correlate International Prognostic Index risk category with FDG-PET results and overall outcome in these patients.
研究设计
- 研究类型
- Interventional
- 主要目的
- Diagnostic
入排标准
- 年龄范围
- 18 Years 至 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed aggressive non-Hodgkin's lymphoma of 1 of the following subtypes:
- •Diffuse large B-cell lymphoma
- •Mediastinal (thymic) B-cell lymphoma
- •Grade 3 follicular lymphoma
- •Anaplastic large cell lymphoma
- •Peripheral T-cell lymphoma
- •Must have adequate staging of disease by the following techniques:
- •CT scan or MRI of affected sites
- •Bone marrow biopsy (in cases where results influence the duration of chemotherapy only)
- •Lumbar puncture (if clinically indicated)
- •Stage I-IV disease
- •Any International Prognostic Index risk category
- •Radiographically measurable disease
- •None of the following aggressive non-Hodgkin's subtypes are allowed:
- •Mantle cell lymphoma
- •Lymphoblastic lymphoma
- •Burkitt's lymphoma
- •Mycosis fungoides/Sezary's syndrome
- •HTLV-1-associated T-cell leukemia/lymphoma
- •Primary CNS lymphoma
- •HIV-associated lymphoma
- •Transformed lymphomas
- •No prior diagnosis of another hematologic malignancy
- •No known progressive disease during prior first-line chemotherapy
- •No active CNS involvement by lymphoma, except CNS involvement at diagnosis that is previously treated and in remission
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status
- •ECOG 0-4 (0-2 for peripheral blood stem cell [PBSC] or bone marrow transplantation [BMT] patients)
- •Life expectancy
- •Not specified
- •Hematopoietic
- •Absolute neutrophil count > 1,000/mm^3*
- •Platelet count ≥ 75,000/mm^3 NOTE: *PBSC or BMT patients only
- •Bilirubin ≤ 2.0 mg/dL unless due to Gilbert's disease or lymphoma*
- •No known significant hepatic dysfunction that is not expected to improve and would preclude PBSC or BMT NOTE: *PBSC or BMT patients only
- •Creatinine ≤ 2.0 mg/dL*
- •No known significant renal dysfunction that is not expected to improve and would preclude PBSC or BMT NOTE: *PBSC or BMT patients only
- •Cardiovascular
- •Ejection fraction ≥ 45% by echocardiogram or MUGA*
- •No known significant cardiac dysfunction that is not expected to improve and would preclude PBSC or BMT NOTE: *PBSC or BMT patients only; a cardiology consult and evaluation may override ejection fraction criterion
- •FEV_1 and FVC ≥ 50% of predicted for patients who have not received thoracic or mantle radiotherapy (75% of predicted for patients who have received thoracic or mantle radiotherapy)*
- •No known significant pulmonary dysfunction that is not expected to improve and would preclude PBSC or BMT NOTE: *PBSC or BMT patients only
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •No other malignancy within the past 3 years except carcinoma in situ of the cervix or nonmelanoma skin cancer
- •No known HIV positivity OR HIV negative (for PBSC or BMT patients only)
- •No serious illness that would preclude study participation
- 另有 12 项未显示
排除标准
- 未提供
结局指标
主要结局
2-year event free survival
次要结局
- Predictive value of early negative fludeoxyglucose F 18 positron emission tomography (FDG-PET)
- Overall survival
- Correlation of International Prognostic Index risk category with FDG-PET results and overall outcome
研究者
研究点 (1)
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