Augmented Berlin-Frankfurt-Munster Therapy Plus Ofatumumab for Young Adults With Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma

M.D. Anderson Cancer Center1 个研究点分布在 1 个国家目标入组 1 人开始时间: 2015年11月13日最近更新: 2018年6月11日

适应症

干预措施

试验速览

阶段: 2 期
状态: 终止
发起方: M.D. Anderson Cancer Center
入组人数: 1
试验地点: 1
主要终点: Event Free Survival (EFS)

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The goal of this clinical research study is to learn if a chemotherapy combination called augmented Berlin-Frankfurt-Munster (BFM), when also combined with ofatumumab or rituximab, can help to control precursor-B ALL or LL in patients who are 12-30 years of age. The safety of these drug combinations will also be studied.

Augmented BFM is made up of daunorubicin, vincristine, prednisone, dexamethasone, PEG asparaginase, and methotrexate.

详细描述

Study Drug Administration:

If you are found to be eligible to take part in this study, on Day 1 or during the spinal tap procedure, you will be given cytarabine as an injection in your spinal fluid.

You will then receive the study drugs in Induction, Consolidation, and Maintenance Courses. Induction Therapy is designed to remove the signs of leukemia that can be seen and to allow normal blood cells to be restored. This is called remission. Consolidation and Maintenance Therapies are designed to cause the disease to stay in remission.

The study drugs will be given the following ways:

Daunorubicin by vein over about 30 minutes
Vincristine by vein over 15-30 minutes
PEG asparaginase by vein over 15-60 minutes
Methotrexate either by mouth or as an injection into your spinal fluid (intrathecal), depending on the course. When given through the spinal fluid, cerebrospinal fluid (CSF) will be collected with each spinal tap to test the fluid for leukemia. If there is disease in your spinal fluid before starting the treatment, you will be given additional methotrexate doses each week until there is no disease present.
Ofatumumab as an injection or by vein. If given by vein, the length of the infusion will depend on how well you tolerate the drug. If ofatumumab is not available, you will be given rituximab by vein over several (about 4-6) hours.
Cyclophosphamide by vein over about 1 hour
Cytarabine as an injection under the skin or by vein. If given by vein, the length of the infusion will depend on how well you tolerate the drug.
Doxorubicin by vein. If given by vein, the length of the infusion will depend on how well you tolerate the drug.
Prednisone, 6-Mercaptopurine, dexamethasone, and 6-Thioguanine are all taken by mouth

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: 12 Years 至 30 Years（Child, Adult）
性别: All
接受健康志愿者: 否

入选标准

•Patients must have precursor-B lymphoblastic leukemia or lymphoma.
•Patients must be untreated or have had only one prior chemotherapy regimen for ALL or LL . Previously treated patients will be analyzed separately.
•Age between 12 to 30 years old
•Patients with central nervous system (CNS) disease or testicular disease are eligible.
•Intrathecal therapy with cytarabine is allowed prior to registration for patient convenience. This is usually done at the time of the diagnostic bone marrow or venous line placement to avoid a second lumbar puncture. Systemic chemotherapy must begin within 72 hours of the first intrathecal treatment.
•Signed informed consent prior to the start of systemic therapy. In the event of enrollment of a minor patient, an attempt to obtain assent from the patient must be documented, and parental consent must be signed.
•Echocardiogram should be done within 7 days of starting therapy if there are cardiac risk factors (e.g., history of hypertension or of myocardial infarction)
•Creatinine should be < 3 mg/dL bilirubin < 3 mg/dl unless due to disease
•Zubrod Performance status of <3
•Patients who received steroids more than 72 hours prior to study enrollment are eligible but will be analyzed separately.
•Lymphoblasts may have any positive expression of cluster of differentiation antigen 20 (CD20) for ofatumumab administration.

排除标准

•Age less than twelve years of age or greater than 30 years.
•More than one prior treatment regimen for ALL or LL.
•The patient is pregnant or unwilling to practice appropriate birth control.
•Presence of the Philadelphia chromosome t(9;22)
•Laboratory or clinical evidence of active infectious hepatitis.