Prognostic Significance of Early Positron Emission Tomography (PET) With Fluorine-18 Fluorodeoxyglucose ([18F] FDG) in Intermediate and High Grade Non-Hodgkin's Lymphoma
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Complete remission as measured by positron emission tomography (PET) at 7-10 days after R-CHOP, and after completion of study treatment
研究概览
简要总结
RATIONALE: Diagnostic procedures, such as positron emission tomography (PET) using fludeoxyglucose F 18, may help in learning how well chemotherapy works to kill cancer cells and allow doctors to plan better treatment. Comparing results of diagnostic procedures done before, during, and after chemotherapy may help doctors predict a patient's response to treatment and help plan the best treatment.
PURPOSE: This clinical trial is studying positron emission tomography using fludeoxyglucose F 18 to see how well it works in predicting response to treatment in patients who are receiving rituximab and combination chemotherapy for newly diagnosed non-Hodgkin's lymphoma.
详细描述
OBJECTIVES:
- Determine the positive and negative predictive values of early positron emission tomography (PET) scanning using fludeoxyglucose F 18 in terms of the probability of patients with newly diagnosed intermediate- or high-grade non-Hodgkin's lymphoma who achieve or do not achieve complete remission, after treatment with 1 course of rituximab and combination chemotherapy comprising cyclophosphamide, doxorubicin, vincristine, and prednisone.
- Determine event free and overall survival of patients with an early positive and negative PET scan treated with this regimen.
- Determine the predictive value of early PET scan response ratio as a continuous variable in terms of response to therapy (assessed at the end of therapy), disease-free survival, and overall survival, in patients treated with this regimen.
- Correlate International Prognostic Index score at presentation with early PET scan results and overall outcome in patients treated with this regimen.
- Correlate the degree of neutropenia 7 to 10 days after the first course of treatment with rituximab and combination chemotherapy with PET scan response and pre-treatment blood CD34-positive cell concentration in these patients.
OUTLINE: This is a multicenter study.
Patients receive fludeoxyglucose F 18 (^18FDG) IV. Beginning 1 hour later, patients undergo whole-body positron emission tomography (PET) scanning. Patients also undergo conventional radiographic staging of their disease.
Patients then receive standard R-CHOP (or an alternative regimen) comprising rituximab IV over 3-6 hours, cyclophosphamide IV over 30 minutes, doxorubicin IV over 5 minutes, and vincristine IV over 5 minutes on day 1 and oral prednisone once daily on days 1-5. Treatment repeats every 14-21 days for up to 4 courses in the absence of unacceptable toxicity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed newly diagnosed non-Hodgkin's lymphoma (NHL)
- •Intermediate- or high-grade disease
- •Stage I-IV disease
- •Any of the following subtypes are allowed:
- •Diffuse large B-cell lymphoma
- •Anaplastic large cell lymphoma
- •Mantle cell lymphoma
- •Grade 3 follicular lymphoma
- •Mediastinal B-cell lymphoma
- •The following subtypes are not allowed:
- •Lymphoblastic lymphoma
- •Mycosis fungoides/Sézary's syndrome
- •HTLV-1 associated T-cell leukemia or lymphoma
- •Primary CNS lymphoma
- •HIV-associated lymphoma
- •Transformed lymphoma
- •Burkitt's lymphoma
- •Adequate staging of lymphoma by any of the following methods:
- •CT scan or MRI of affected sites
- •Unilateral or bilateral bone marrow biopsy
- •Positive pre-treatment positron emission tomography (PET) scan
- •Lumbar puncture
- •Radiographically measurable disease by PET scan
- •Any International Prognostic Index risk category allowed
- •No prior diagnosis of another hematologic malignancy NOTE: A new classification scheme for adult non-Hodgkin's lymphoma has been adopted by PDQ. The terminology of "indolent" or "aggressive" lymphoma will replace the former terminology of "low", "intermediate", or "high" grade lymphoma. However, this protocol uses the former terminology.
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status
- •Not specified
- •Life expectancy
- •Not specified
- •Hematopoietic
- •Absolute neutrophil count > 1,000/mm^3*
- •Platelet count ≥ 75,000/mm^3* NOTE: *Unless due to NHL
- •Bilirubin ≤ 2.0 mg/dL* (excluding Gilbert's disease) NOTE: *Unless due to NHL
- •Creatinine ≤ 2.0 mg/dL (unless due to NHL)
- •Cardiovascular
- •Ejection fraction ≥ 45% by echocardiogram or MUGA
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •HIV negative
- •No other malignancy within the past 5 years except superficial nonmelanoma skin cancer or carcinoma in situ of the cervix
- •No other serious co-morbid disease that would preclude study participation
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •No prior rituximab for NHL
- •No concurrent filgrastim [G-CSF] during course 1 of study treatment except for patients > 70 years of age OR patients with active infection
- •Chemotherapy
- 另有 8 项未显示
排除标准
- 未提供
结局指标
主要结局
Complete remission as measured by positron emission tomography (PET) at 7-10 days after R-CHOP, and after completion of study treatment
时间窗: at 7-10 days after R-CHOP, and after completion of study treatment
Overall survival at 7-10 days after R-CHOP, and after completion of study treatment
时间窗: at 7-10 days after R-CHOP, and after completion of study treatment
Disease-free survival at 7-10 days after R-CHOP, and after completion of study treatment
时间窗: at 7-10 days after R-CHOP, and after completion of study treatment
次要结局
未报告次要终点