NCT00302757已完成1 期
Multicenter Phase I/II Study of Radioimmunotherapy With 90Y-ibritumomab Tiuxetan in a Nonmyeloablative Conditioning Regimen for Allogeneic Hematopoietic Cell Transplantation From HLA-identical Donors in Patients With Advanced Non-Hodgkin Lymphoma
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 22
- 主要终点
- treatment related toxicity
研究概览
简要总结
The study evaluates the additional use of radioimmunotherapy with a 90-Yttrium labeled monoclonal antibody targeting lymphoma cells in two dose reduced conditioning regimens for allogeneic hematopoietic cell transplantation from human leukocyte antigen (HLA)-identical donors. Radioimmunotherapy should allow an increased anti-lymphoma effect of the conditioning while the allogeneic grafts may confer potent graft versus lymphoma effects and rescue from potential hematopoietic side effects of the radioimmunotherapy. The study evaluates the feasibility and toxicity of such approach and will also analyze disease response and survival of the patients treated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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
- •Patients with advanced CD20+ NHL (non-Hodgkin lymphoma) relapsed after at least two preceding chemotherapy regimens including treatment with rituximab or with relapse after autologous HCT (hematopoietic cell transplantation)
- •The following entities of lymphomas can be included in Arm A of the protocol:
- •Small lymphocytic lymphoma (SLL/CLL)
- •Mantle cell lymphoma (MCL)
- •Follicular lymphoma Grade 1-2
- •Marginal zone lymphoma (MZL)
- •Extranodal (MALT lymphoma)
- •Nodal (Monocytoid B-cell lymphoma)
- •The following lymphoma entities can be included in Arm B of the protocol:
- •Diffuse large B-cell lymphoma/follicular lymphoma grade 3
- •Grade 3 follicular lymphoma
- •Blastic mantle cell lymphoma
- •Mediastinal B-cell lymphoma
- •Age > 18, < 70 years
- •Karnofsky score > 60%
- •HLA-identical related or unrelated donor
- •CD20+ lymphoma cells on biopsy or peripheral blood
- •Disease stage at inclusion: CR, PR or SD
排除标准
- •Patients with rapidly progressive disease
- •Less than 3 months after preceding HCT
- •CNS involvement with disease
- •Fungal infections with radiological progression after receipt of amphotericin B or active triazole for greater than 1 month
- •Liver function abnormalities with bilirubin > 2 mg/dL and elevation of transaminases higher than 2x upper limit of normal
- •Chronic active viral hepatitis
- •Ejection fraction < 40% on echocardiography
- •Patients with > grade II hypertension by CTC criteria
- •Creatinine clearance < 50 ml/min
- •Respiratory failure necessitating supplemental oxygen or DLCO < 30%
- •Allergy against murine antibodies
- •HIV infection
- •Female patients who are pregnant or breast feeding, or adults of reproductive potential not employing an effective method of birth control during study treatment and for at least 12 months thereafter. (Women of childbearing potential must have a negative serum pregnancy test at study entry.)
- •Patients with pleural effusion or ascites
- •Concurrent severe and/or uncontrolled medical disease (e.g. uncontrolled diabetes, congestive heart failure, myocardial infarction within 6 months prior to the study, unstable and uncontrolled hypertension, chronic renal disease, or active uncontrolled infection) which could compromise participation in the study
- •Patients who received any investigational drugs less than 4 weeks before entry in this study or who have not as yet recovered from the toxic effects of such therapy
- •Patients who underwent surgery within 4 weeks of entering the study or patients who have not as yet recovered from the side-effects of such treatment
- •Patients with a history of psychiatric illness or condition which could interfere with their ability to understand the requirements of the study (this includes alcoholism/drug addiction)
- •Patients unwilling or unable to comply with the protocol
- •Unable to give informed consent
- •Enrollment in another trial interfering with the endpoints of this study
结局指标
主要结局
treatment related toxicity
engraftment
次要结局
- graft versus host disease (GVHD)
- overall survival
- immunoreconstitution
- disease response
- relapse rate
- disease free survival
研究者
研究点 (22)
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