Zevalin/BEAM/Rituximab vs BEAM/Rituximab With or Without Rituximab Maintenance in Autologous Stem Cell Transplantation for Diffuse Large B-Cell Lymphomas

M.D. Anderson Cancer Center1 个研究点分布在 1 个国家目标入组 30 人开始时间: 2007年11月14日最近更新: 2021年2月2日

适应症

干预措施

试验速览

阶段: 2 期
状态: 已完成
发起方: M.D. Anderson Cancer Center
入组人数: 30
试验地点: 1
主要终点: Number of Participants With a 2-Year Progression-Free Survival (PFS)

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 the addition of 90Y Zevalin to BEAM chemotherapy (carmustine, etoposide, cytarabine, and melphalan) and rituximab is more effective than the combination of BEAM and rituximab alone in patients with lymphoma who receive a stem cell transplant.

详细描述

The Study Drugs:

90Y Zevalin is designed to attach to lymphoma cells, and destroy the cells using a radiation particle that is attached to it.

111In Zevalin is like 90Y Zevalin, but the radioactive particle that is attached to it does not kill lymphoma cells. The radioactive particle makes the drug able to be seen inside your body. It is being used in this study to predict how fast the study drug will travel in the body and how long the drug stays in the body.

Carmustine, etoposide, cytarabine, and melphalan (BEAM) are designed to kill lymphoma cells by damaging the cells DNA.

Rituximab is designed to attach to lymphoma cells, which may cause them to die.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Parallel
主要目的: Treatment
盲法: None

入排标准

年龄范围: 18 Years 至 70 Years（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•Relapsed CD20-positive B-cell diffuse large cell lymphoma (demonstrated in lymph nodes or bone marrow), chemosensitive (at least PR).
•Age: up to 18-70 years of age.
•Prestudy performance status of 0, 1, or 2 according to the WHO.
•No anti-cancer therapy started within three weeks, prior to study initiation, and fully recovered from all toxicities associated with prior surgery, radiation treatments, chemotherapy, or immunotherapy. No prior rituximab within three weeks of starting therapy.
•If patients had prior radiation, this should have not involved more than 25% of the bone marrow.
•Acceptable hematologic status within two weeks prior to patient registration, including: Absolute neutrophil count ({segmented neutrophils + bands} x total WBC) > 1,500/mm³ and platelet counts > 80,000/mm³
•IRB -approved signed informed consent.
•Patients determined to have <10% bone marrow involvement with lymphoma within 60 days before study entry as defined by bone marrow aspirates and biopsies.
•Female patients included must not be pregnant or lactating.
•Patients should have at least 4-6 x 10^6 CD34+/kg peripheral stem cells collected. Around 1-2 million cells will beheld as back up.
•Voluntary signed, written IRB-approved informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care.
•Men and women of reproductive potential must agree to follow accepted birth control methods for the duration of the study. Female subject is either post-menopausal or surgically sterilized or willing to use an acceptable method of birth control (i.e., a hormonal contraceptive, intra-uterine device, diaphragm with spermicide, condom with spermicide, or abstinence) for the duration of the study. Male subject agrees to use an acceptable method for contraception for the duration of the study.

排除标准

•Failed stem cell collection of >/= 4x10^6CD34+/kg.
•Prior radioimmunotherapy.
•Presence of active CNS lymphoma.
•Patients with abnormal liver function: total bilirubin > 1.5 mg/dl.
•Patients with abnormal renal function: serum creatinine > 1.6 mg/dl.
•Serious nonmalignant disease or infection which, in the opinion of the investigator and/or the sponsor, would compromise other protocol objectives.
•Corrected DLCO < 50% and FEV subscript 1 or FVC < 50% predicted.
•Cardiac EF < 50% by 2-D Echogram.
•Prior radiation to lungs.
•Abnormal cytogenetics predictive of secondary cancers, such as -5,-
•Pregnant (Positive Beta HCG test in a woman with child bearing potential defined as not post-menopausal for 12 months or no previous surgical sterilization) or currently breast-feeding. Pregnancy testing is not required for post-menopausal or surgically sterilized women.
•Patients with other malignancies diagnosed within 2 years prior to Study entry (except skin squamous or basal cell carcinoma).
•Active uncontrolled bacterial, viral fungal infections.
•Major surgical procedure or significant traumatic injury within 4 weeks prior to Study entry.
•Serious, non-healing wound, ulcer, or bone fracture.
•History of abdominal fistula, gastrointestinal perforation or intra-abdominal abscess within 3 months prior to Study entry.
•History of Stroke within 6 months.
•Myocardial infarction within the past 6 months prior to Study Day 1, or has New York Heart Association (NYHA) Class III or IV heart failure or arrythmias, unstable angina, uncontrolled congestive heart failure or arrythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities. Prior to study entry, any ECG abnormality at screening must be documented by investigator as not medically relevant.
•Uncontrolled chronic diarrhea.
•Serious medical or psychiatric illness likely to interfere with participation in this clinical study.