Phase 2 Study of Bexxar in Relapsed/Refractory Diffuse Large Cell Lymphoma (DLCL)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- Clinical Response Rate
研究概览
简要总结
The purpose of this study is to obtain safety and efficacy data using Bexxar in patients with relapsed/refractory diffuse large cell Non-Hodgkin's lymphoma (DLCL).
详细描述
There is a lack of efficacious treatment options for patients with relapsed/refractory diffuse large cell Non-Hodgkin's lymphoma (DLCL) who are not appropriate candidates for stem cell transplantation. DLCL is a relatively radiosensitive disease and patients with DLCL have been reported to respond to anti-CD20 monoclonal antibody (MAB) therapy. Therefore, radioimmunotherapy targeting CD20 is a rational and promising therapeutic approach for this patient population.
This study evaluated if Bexxar is safe and efficacious for diffuse large cell Non-Hodgkin's lymphoma.
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
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically-confirmed, diffuse large cell lymphoma (DLCL), CD20+ B-cell non-Hodgkin lymphoma (NHL) who have relapsed after chemotherapy or are chemotherapy resistant, without prior history of low grade NHL. The patient must have failed at least one chemotherapy regimen containing an anthracycline or equivalent chemotherapeutic agent.
- •No anticancer treatment for three weeks prior to the treatment dose of Bexxar (6 weeks if Rituximab, nitrosourea or Mitomycin C)
- •Fully recovered from all toxicities associated with prior surgery, radiation, chemotherapy or immunotherapy
- •An Institutional Review Board (IRB)-approved signed informed consent
- •Age 19 years or older
- •Prestudy Karnofsky Performance Status of ≥ 70%
- •Absolute neutrophil count (ANC) ≥ 1,500/mm³
- •Platelet count ≥ 100,000/mm³
- •Hct > 30%
- •Hgb > 9.0 gm%
- •Bilirubin ≤ 2.0
- •Creatinine ≤ 2.0
- •Bone marrow involvement with lymphoma less than 25% (bilateral bone marrow) within 6 weeks of enrollment
- •Acceptable birth control method for men and women
- •Female patients who are not pregnant
- •Not lactating
排除标准
- •Prior myeloablative therapies with bone marrow transplantation or peripheral stem cell rescue
- •Platelet count < 100,000/mm³
- •Hypocellular bone marrow (≤ 15% cellularity)
- •Marked reduction in bone marrow precursors of one or more cell lines
- •History of failed stem cell collection
- •Prior treatment with Fludarabine
- •Prior radioimmunotherapy
- •Presence of central nervous system (CNS) lymphoma
- •Patients with known HIV or AIDS-related lymphoma
- •Patients with evidence of myelodysplasia on bone marrow biopsy
- •Patients who have received prior external beam radiation therapy to more than 25% of active bone marrow
- •Patients who have received filgrastim or sargramostim therapy within 3 weeks prior to treatment
- •Lactating
- •Presence of human anti-mouse antibody (HAMA) reactivity in patients with prior exposure to murine antibodies or proteins
- •Serious nonmalignant disease or infection, which, in the opinion of the investigator, would compromise other protocol objectives
- •Another primary malignancy (other than squamous cell and basal cell carcinoma of the skin, in situ carcinoma of the cervix, or treated prostate cancer with stable prostate specific antigen levels) for which the patients has not been disease-free for at least 3 years
- •Major surgery, other than diagnostic surgery, within 4 weeks
- •Patients with pleural effusion
研究组 & 干预措施
Bexxar + Total Body Irradiation (TBI)
Bexxar will be administered with pre-medications acetaminophen, diphenhydramine, and potassium iodide (KI).
干预措施: Potassium Iodide (KI) (Drug)
Bexxar + Total Body Irradiation (TBI)
Bexxar will be administered with pre-medications acetaminophen, diphenhydramine, and potassium iodide (KI).
干预措施: Diphenhydramine (Drug)
Bexxar + Total Body Irradiation (TBI)
Bexxar will be administered with pre-medications acetaminophen, diphenhydramine, and potassium iodide (KI).
干预措施: Bexxar (Drug)
Bexxar + Total Body Irradiation (TBI)
Bexxar will be administered with pre-medications acetaminophen, diphenhydramine, and potassium iodide (KI).
干预措施: Acetaminophen (Drug)
结局指标
主要结局
Clinical Response Rate
时间窗: 6 years
Clinical response rate for all participants, reported as the sum of the numbers of patients achieving complete response (CR, complete disappearance of all lesions); functional CR (fCR, minimal residual disease but clear of disease by positron emission tomography (PET)-scan); or partial response (PR, ≥ decrease in size of lesions and negative for active disease by PET-scan). Progressive disease (PD, advancing cancer) or stable disease (not CR, fCR, or PD) not included as Clinical Response.
次要结局
- Time to Progression (TTP)(1.5 months; 3 months; 6 months; or Not Progressed)
- Overall Survival (OS) Rate(6 years)
研究者
Susan Knox
Associate Professor
Stanford University