A Phase II Study of Rituximab Intense Dosing With CHOP-21 (RID-CHOP) in Patients With Previously Untreated High or High-Intermediate Risk IPI (3-5) Diffuse Large B-Cell Lymphoma (DLBCL)
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- PFS following treatment with rituximab intense dosing and CHOP-21 in previously untreated patients with high risk DLBCL
研究概览
简要总结
This phase II trial studies how well giving rituximab together with combination chemotherapy works in treating patients with previously untreated high- or high-intermediate-risk diffuse large B-cell lymphoma (DLBCL). Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Drugs used in chemotherapy, such as cyclophosphamide, doxorubicin hydrochloride, vincristine sulfate, and prednisone (CHOP), 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 rituximab together with combination chemotherapy together may be an effective treatment for DLBCL
详细描述
PRIMARY OBJECTIVES:
I. To evaluate 1 year progression-free survival (PFS) following treatment with rituximab intense dosing and CHOP-21 (RID-CHOP) in previously untreated patients with high risk (International Prognostic Index [IPI] 3-5) DLBCL.
SECONDARY OBJECTIVES:
I. To evaluate, in previously untreated patients with high risk (IPI 3-5) DLBCL treated with rituximab intense dosing and CHOP-21: Complete response (CR) rate, (as defined by International Harmonization Project criteria using 18-fluorodeoxyglucose [FDG] -positron emission tomography [PET]/computed tomography [CT]).
II. Overall survival.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- •Newly diagnosed cluster of differentiation (CD) 20+ DLBCL with IPI between 3-5
- •No prior chemotherapy, radiation therapy or immunotherapy for DLBCL; a short course (< 2 weeks) of corticosteroids is allowed for symptom control Signed informed consent
- •Eastern Cooperative Oncology Group (ECOG) Performance status assessed between 0 and 2; performance status of 3 will be accepted if impairment is caused by DLBCL complications and improvement is expected once therapy is initiated
- •Measurable disease by Non-Hodgkin's Lymphoma Response Criteria on FDG-PET/CT; baseline measurements and evaluations must be obtained =< 21 days prior to registration
- •Absolute neutrophil count (ANC) >= 1,500/μL unless due to marrow involvement by lymphoma
- •Platelets >= 75,000/μL unless due to marrow involvement by lymphoma Hemoglobin > 7.0 g/dL unless due to marrow involvement by lymphoma
- •Creatinine =< 2.0 mg/dL or calculated creatinine clearance >= 40
- •Total bilirubin =< 1.5 mg/dL unless due to Gilbert's disease
- •Aspartate aminotransferase (AST)/ alanine aminotransferase (ALT) =< 2.5 the upper limit of normal
- •Alkaline phosphatase =< 5x upper limit of normal
- •Patients with bilirubin between 1.5-3.0 mg/dL due to lymphoma may be entered and doses adjusted
- •Left ventricular ejection fraction (LVEF) >= 50%
排除标准
- •Women who are pregnant or breast feeding
- •Known seropositivity for human immunodeficiency virus (HIV)
- •Known presence of central nervous system (CNS) involvement by lymphoma
- •New York Heart Association Classification III or IV heart
- •Current or chronic hepatitis B or hepatitis C infection (as detected by positive testing for Hepatitis B surface Antigen [Hbs Ag] or antibody to Hepatitis C virus [anti HCV] respectively); patients must be tested for Hepatitis B surface antigen and anti-HCV =< 21 days prior to registration
- •Male patients (with female sexual partners of childbearing potential) and female patients of childbearing potential who refuse to use effective methods of contraception
- •Unstable or severe uncontrolled medical, psychological, or social condition
- •Any evidence of serious active, uncontrolled infection (i.e., requiring an IV antibiotic or antiviral agent)
- •Receipt of live vaccine within 4 weeks prior to study drug administration
- •Concurrent active malignancy other than non-melanoma skin cancer or carcinoma in situ of the cervix; subjects with previous malignancies are eligible provided that they have been treated with curative intent and remain disease free for 3 years or more
- •No prior chemotherapy for lymphoma
- •Prior radiation therapy for lymphoma
- •Any important medical illness or abnormal laboratory finding that would, in the investigator's judgment, significantly increase the subject's risk of participating in this study
研究组 & 干预措施
Treatment (monoclonal antibody, combination chemotherapy)
Patients receive rituximab IV on days 0, 1, 4, 8, and 15 of course 1; days 1, 8, and 15 of course 2; and day 1 of all subsequent courses. Patients also receive CHOP chemotherapy comprising cyclophosphamide IV, doxorubicin hydrochloride IV, and vincristine sulfate IV on day 1, and prednisone PO on days 1-5. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.
干预措施: rituximab (Biological)
Treatment (monoclonal antibody, combination chemotherapy)
Patients receive rituximab IV on days 0, 1, 4, 8, and 15 of course 1; days 1, 8, and 15 of course 2; and day 1 of all subsequent courses. Patients also receive CHOP chemotherapy comprising cyclophosphamide IV, doxorubicin hydrochloride IV, and vincristine sulfate IV on day 1, and prednisone PO on days 1-5. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.
干预措施: cyclophosphamide (Drug)
Treatment (monoclonal antibody, combination chemotherapy)
Patients receive rituximab IV on days 0, 1, 4, 8, and 15 of course 1; days 1, 8, and 15 of course 2; and day 1 of all subsequent courses. Patients also receive CHOP chemotherapy comprising cyclophosphamide IV, doxorubicin hydrochloride IV, and vincristine sulfate IV on day 1, and prednisone PO on days 1-5. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.
干预措施: doxorubicin hydrochloride (Drug)
Treatment (monoclonal antibody, combination chemotherapy)
Patients receive rituximab IV on days 0, 1, 4, 8, and 15 of course 1; days 1, 8, and 15 of course 2; and day 1 of all subsequent courses. Patients also receive CHOP chemotherapy comprising cyclophosphamide IV, doxorubicin hydrochloride IV, and vincristine sulfate IV on day 1, and prednisone PO on days 1-5. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.
干预措施: vincristine sulfate (Drug)
Treatment (monoclonal antibody, combination chemotherapy)
Patients receive rituximab IV on days 0, 1, 4, 8, and 15 of course 1; days 1, 8, and 15 of course 2; and day 1 of all subsequent courses. Patients also receive CHOP chemotherapy comprising cyclophosphamide IV, doxorubicin hydrochloride IV, and vincristine sulfate IV on day 1, and prednisone PO on days 1-5. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.
干预措施: prednisone (Drug)
Treatment (monoclonal antibody, combination chemotherapy)
Patients receive rituximab IV on days 0, 1, 4, 8, and 15 of course 1; days 1, 8, and 15 of course 2; and day 1 of all subsequent courses. Patients also receive CHOP chemotherapy comprising cyclophosphamide IV, doxorubicin hydrochloride IV, and vincristine sulfate IV on day 1, and prednisone PO on days 1-5. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.
干预措施: laboratory biomarker analysis (Other)
Treatment (monoclonal antibody, combination chemotherapy)
Patients receive rituximab IV on days 0, 1, 4, 8, and 15 of course 1; days 1, 8, and 15 of course 2; and day 1 of all subsequent courses. Patients also receive CHOP chemotherapy comprising cyclophosphamide IV, doxorubicin hydrochloride IV, and vincristine sulfate IV on day 1, and prednisone PO on days 1-5. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.
干预措施: pharmacological study (Other)
结局指标
主要结局
PFS following treatment with rituximab intense dosing and CHOP-21 in previously untreated patients with high risk DLBCL
时间窗: 1 year
Defined as the time from entry onto study until lymphoma progression or death from any cause.
次要结局
- CR in previously untreated patients with high risk DLBCL treated with rituximab intense dosing and CHOP-21(Baseline, between days 15 and 21 of course 3, and within 20-35 days after completion of treatment)