NCT00142181已完成2 期
Phase II Study of Campath-1H in Patients With Lymphoplasmacytic Lymphoma (Waldenstrom's Macroglobulinemia)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 27
- 试验地点
- 3
- 主要终点
- To determine the effectiveness of Campath-1H in treating patients with Waldenstrom's macroglobulinemia.
研究概览
简要总结
The purpose of this study is to determine the safety and effects (good or bad) of Campath-1H antibody in the treatment of lymphoplasmacytic lymphoma.
详细描述
- Patients will receive 3 test doses of Campath-1H (3mg, 10mg, 30mg). If the patient tolerates these three test doses, then they will receive a total of 6 weeks of Campath-1H therapy three times a week.
- After the patient receives the first 6 weeks of therapy at the 30mg therapeutic dose they will be re-assessed by blood testing. If it is determined that their disease has progressed in the period of time while the patient was on Campath-1H, the patient will be removed from the study.
- If it is determined that the patient has achieved a complete remission after 6 weeks of Campath-1H treatment a bone marrow biopsy will be performed to confirm complete remission and the patient will not receive any additional treatment but will be followed for a period of 2 years.
- If the disease has remained stable or partial response has been achieved the patient will enter the second phase of therapy in which they will receive an additional 6 weeks of Campath-1H therapy. The patient will then be reassessed as described above.
- No additional therapy (as part of this study) will be performed after a 12 week course of Campath-1H.
- While the patient is on Campath-1H blood test will be performed at 3-6 month intervals over a period extending for 2 years following the last treatment. Bone marrow biopsies and/or aspirations will be conducted as necessary.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of lymphoplasmacytic lymphoma including patients with Waldenstrom's macroglobulinemia
- •Adequate organ function: ANC > 500/ul; PLT > 25,000/ul; serum creatinine < 2.5; serum total bilirubin and SGOT < 2.5 times the upper normal limit.
- •Age greater than 18 years
- •Life expectancy of 6 months or greater
- •ECOG performance status of 0-2
排除标准
- •Chemotherapy, steroid therapy, or radiation therapy within 21 days of study entry.
- •Prior Campath-1H or monoclonal antibody therapy within 3 months of study entry.
- •Pregnant women
- •Serious co-morbid disease, uncontrolled bacterial, fungal, or viral infection.
研究组 & 干预措施
Campath-1H
Experimental
30 mg IV three times a week, 6-12 weeks.
干预措施: Campath-1H (Drug)
结局指标
主要结局
To determine the effectiveness of Campath-1H in treating patients with Waldenstrom's macroglobulinemia.
时间窗: 2 years
次要结局
- To determine the safety of Campath-1H.(2 years)
研究者
Steven P. Treon, MD, PhD
Principal Investigator
Dana-Farber Cancer Institute
研究点 (3)
Loading locations...
相似试验
已完成
1 期
A Phase 1a, Double-Blind, Placebo-Controlled, Single Ascending Dose Study to Evaluate Lpathomab in Healthy VolunteersHealthy SubjectsNCT02341508Lpath, Inc.36
撤回
2 期
Efficacy and Safety of SM101 in the Treatment of IgA NephropathyImmunoglobulin A NephropathyNCT02605525Baxalta now part of Shire
Unknown
1 期
Clinical Safety and Preliminary Efficacy of AAV-DC-CTL Treatment in Stage IV Gastric CancerStage IV Gastric CancerNCT01637805Tianjin Medical University Cancer Institute and Hospital30
招募中
1 期
Safety and Efficacy of SMART101 in Pediatric and Adult Patients With Hematological Malignancies After T Cell Depleted Allo-HSCTHematological MalignanciesNCT04959903Smart Immune SAS36
已完成
1 期
A Phase I/II Study Of Immunization With Lymphotactin And Interleukin 2 Gene Modified Neuroblastoma Tumor CellsNeuroblastomaNCT00703222Baylor College of Medicine7