A Phase II Study of Bendamustine, Mitoxantrone, and Rituximab (BMR) for Patients With Untreated High Risk Follicular Lymphoma
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- Complete Response Rate of the Combination of BMR (Bendamustine + Mitoxantrone + Rituximab)
研究概览
简要总结
The goal of this clinical research study is to learn if the combination of bendamustine hydrochloride, mitoxantrone, and rituximab can help to control follicular lymphoma.
The safety of this drug combination will also be studied.
详细描述
The Study Drugs:
Bendamustine is designed to damage and destroy the DNA (genetic material) of cancer cells.
Mitoxantrone is designed to stop cancer cells from making DNA, which may stop the cells from making more cells.
Rituximab is designed to attach to lymphoma cells, which may cause them to die.
Study Drug Administration:
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
- •Age >18 years at the time of signing the informed consent form.
- •Able to adhere to the study visit schedule and other protocol requirements.
- •Untreated grade 1, 2, or 3a follicular non-Hodgkin's lymphoma.
- •At least one measurable lesion according to the International Working Group Criteria for Response, of greater that 1.5cm.
- •Eastern Cooperative Oncology Group (ECOG) performance status of < 2 at study entry.
- •Laboratory test results within these ranges: Absolute neutrophil count >/=1.5 x 10^9/L; Platelet count >/=100 x 10^9/L; Serum creatinine </= 2.0 mg/dL; Total bilirubin </= 1.5 mg/dL; AST (SGOT) and ALT (SGPT) </= 2 x upper limit of normal (ULN) or </= 5 x ULN if hepatic metastases are present.
- •Disease free of prior malignancies for at least 5 years with exception of currently treated basal cell, squamous cell carcinoma of the skin, or carcinoma in-situ of the cervix or breast.
- •Have a high risk FLIPI score, as defined by a FLIPI score >/=
- •Females of childbearing potential (FCBP) must have a negative serum or urine pregnancy test with a sensitivity of at least 50 milli-International unit (mIU)/mL within 10 to 14 days prior to study entry.
- •An ejection fraction of >/= 50% as documented by a cardiac function study.
排除标准
- •Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form.
- •Pregnant or breast feeding females.
- •Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study.
- •Use of any prior chemotherapy for follicular lymphoma.
- •Known hypersensitivity to Bendamustine, mitoxantrone, or mannitol.
- •A history of congestive heart failure.
- •Any prior use of bendamustine or mitoxantrone.
- •Concurrent use of other anti-cancer agents or experimental treatments.
- •Known positive for HIV or infectious hepatitis type B or C.
- •Creatinine clearance less than 40 ml/min.
- •A known history of hepatic insufficiency (patients with a history of fulminate hepatic failure, hepatic encephalopathy, cirrhosis, and autoimmune hepatitis).
- •Any history of grade 3b follicular lymphoma.
研究组 & 干预措施
Bendamustine + Mitoxantrone + Rituximab
Bendamustine starting dose 90 mg/m^2 intravenously (IV) over 30-60 minutes on Days 1 and 2 of each 8-day cycle. Mitoxantrone 10 mg/m^2 IV over 15 minutes on Day 2 of each cycle. Rituximab 375 mg/m^2 IV over several hours on Day 1 of each cycle.
干预措施: Bendamustine (Drug)
Bendamustine + Mitoxantrone + Rituximab
Bendamustine starting dose 90 mg/m^2 intravenously (IV) over 30-60 minutes on Days 1 and 2 of each 8-day cycle. Mitoxantrone 10 mg/m^2 IV over 15 minutes on Day 2 of each cycle. Rituximab 375 mg/m^2 IV over several hours on Day 1 of each cycle.
干预措施: Mitoxantrone (Drug)
Bendamustine + Mitoxantrone + Rituximab
Bendamustine starting dose 90 mg/m^2 intravenously (IV) over 30-60 minutes on Days 1 and 2 of each 8-day cycle. Mitoxantrone 10 mg/m^2 IV over 15 minutes on Day 2 of each cycle. Rituximab 375 mg/m^2 IV over several hours on Day 1 of each cycle.
干预措施: Rituximab (Drug)
结局指标
主要结局
Complete Response Rate of the Combination of BMR (Bendamustine + Mitoxantrone + Rituximab)
时间窗: 3 months
To evaluate the complete response rate of the combination of BMR in previously untreated follicular non-Hodgkin's lymphoma. CR defined by International Working Group Criteria for Response for Non-Hodgkin's Lymphoma as complete disappearance of all detectable clinical evidence of disease and disease-related symptoms.
次要结局
- Participants With Adverse Events(3 months)
- Time to Progression (TTP) for Participants Treated With BMR (Bendamustine, Mitoxantrone, and Rituximab)(5 months)