A Randomized Trial of Rituximab vs Alemtuzumab vs Alemtuzumab + Rituximab as Consolidation Therapy for Patients With Chronic Lymphocytic Leukemia (CLL) With Evidence of Residual Disease Following Prior Chemo(Immuno)Therapy
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- Number of Patients With Molecular Remissions at 52 Weeks
研究概览
简要总结
The goal of this clinical research study is to find out how well Campath (alemtuzumab), Rituxan (rituximab), or a combination of the 2 drugs may control Chronic Lymphocytic Leukemia (CLL) that is left after chemotherapy. The safety of these drugs will also be studied.
详细描述
Study Drugs:
Alemtuzumab and rituximab are both monoclonal antibodies. Monoclonal antibodies are proteins designed to attach to a protein on the surface of the leukemia cell. By attaching to the leukemia cell, monoclonal antibodies alert the immune system to target that cell and kill it.
Study Groups:
If you are found to be eligible to take part in this study, you will be randomly assigned (as in the roll of a dice) to 1 of 3 groups. Group 1 will receive rituximab alone. Group 2 will receive alemtuzumab alone. Group 3 will receive both drugs together.
At the beginning of the study, the chance of being assigned into any of the groups is about equal. However, once enough participants are on study and the response rate in each group is known, you will have a slightly better chance of being assigned to the group with the highest response rate.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with CLL, CLL/prolymphocytic leukemia (PLL), or Small Lymphocytic Lymphoma (SLL) who have achieved an National Cancer Institute-Working Group (NCI-WG) nodular partial (nPR) or complete response (CR) with documentation of residual disease by MRD flow cytometry following chemotherapy or chemoimmunotherapy.
- •Patients with CLL, CLL/PLL, or SLL who have achieved an NCI-WG partial response (PR) following prior chemotherapy or chemoimmunotherapy.
- •Age >/=18 years.
- •ECOG performance status </=
- •Serum creatinine </= 2 mg/dL; serum total bilirubin </= 2 mg/dL; serum AST or ALT <4 x ULN.
- •Signed informed consent.
- •Male and female patients who are fertile agree to use an effective barrier method of birth control (ie, latex condom, diaphragm, cervical cap, etc.) to avoid pregnancy. Female patients of childbearing potential (non-childbearing is defined as >/= 1 year post-menopausal or surgically sterilized) need a negative serum or urine pregnancy test within 14 days of study enrollment.
排除标准
- •Past history of anaphylaxis following exposure to rat or mouse derived complementarity determining region (CDR)-grafted humanized monoclonal antibodies.
- •Hormonal therapy within 2 weeks prior to study start. Hormonal replacement therapy is permitted.
- •Active Hepatitis B (at least one of the following markers positive: HBsAg, HBeAg, IgM anti-HBc, HBV DNA).
- •Previous treatment with alemtuzumab plus rituximab in combination.
- •Pregnant or nursing women.
- •History of HIV infection.
- •Active uncontrolled infection (defined as exhibiting ongoing signs/symptoms related to the infection and without improvement, despite appropriate antibiotics or other treatment).
- •Less than 6 months from the completion of prior chemotherapy or chemoimmunotherapy. Completion of prior chemoimmunotherapy is defined as the last day of therapy of the respective treatment regimen.
- •Symptomatic CNS disease.
研究组 & 干预措施
Rituximab
Group 1: 375 mg/m^2 IV Rituximab Alone
干预措施: Rituximab (Drug)
Alemtuzumab
Group 2: 30 mg SQ Alemtuzumab Alone
干预措施: Alemtuzumab (Drug)
Rituximab + Alemtuzumab
Group 3: 375 mg/m^2 Rituximab + 30 mg SQ Alemtuzumab
干预措施: Rituximab (Drug)
Rituximab + Alemtuzumab
Group 3: 375 mg/m^2 Rituximab + 30 mg SQ Alemtuzumab
干预措施: Alemtuzumab (Drug)
结局指标
主要结局
Number of Patients With Molecular Remissions at 52 Weeks
时间窗: 52 weeks
Molecular Remissions (minimal residual disease (MRD) flow cytometry-negative) after monoclonal antibody consolidation therapy. Molecular remission is defined as resolution of all detectable disease below the limits of the MRD flow cytometry assay sensitivity.
次要结局
- 52 Week Toxicity Rate(52 weeks)
- Progression-free Survival(52 weeks or until disease progression)