Phase II Study of Zevalin for the Treatment of Early-Stage Indolent Lymphomas
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 31
- 试验地点
- 1
- 主要终点
- Overall Response Rate (ORR)
研究概览
简要总结
The goal of this clinical research study is to find out if giving (Rituxan) rituximab with 90Y (ibritumomab tiuxetan) (90 Y Zevalin®) may be effective in treating low-grade lymphoma. The safety of this combination treatment will also be studied.
详细描述
90 Y Zevalin and rituximab are both designed to attach to lymphoma cells, causing them to die.
Before you can start treatment on this study, you will have "screening tests." These tests will help the doctor decide if you are eligible to take part in this study. You will have a physical exam. Blood (about 2 to 3 teaspoons) and urine will be collected for routine tests. You will have a chest x-ray and computerized tomography (CT) scans of the neck, chest, abdomen (stomach area), and pelvis.
A PET scan is also recommended. A PET (Positron Emission Tomography) scan is a medical technique that monitors the activity in the brain and other organs by tracking the movement of a special radioactive solution through the body. The radioactive solution is either inhaled as a mist or injected into a vein. The radioactive solution is usually made from simple sugar that has radioactive particles attached to it. After the solution is injected into a vein or inhaled, the PET scanner takes pictures of the radioactive solution as it moves through the body and collects in various organs. By watching how the solution travels through the body and studying where the solution collects, researchers can learn the extent of disease in certain organs in the body.
You will have an electrocardiogram (ECG -- a test that measures the electrical activity of the heart). You will have a bone marrow aspirate and biopsy performed. To collect a bone marrow aspirate and biopsy, an area of the hip or chest bone is numbed with anesthetic, and a small amount of bone marrow and bone is withdrawn through a large needle. Women who are able to have children must have a negative blood or urine pregnancy test.
If you are found to be eligible to take part in this study, you will be given diphenhydramine (Benadryl) by vein and you will take acetaminophen (Tylenol) by mouth before each dose of rituximab. This is done to help decrease the risk of developing side effects of rituximab. You will then receive 1 dose of rituximab by vein over about 4-6 hours on Day 1 of treatment. After treatment with rituximab, you will then be given 111 In Zevalin (this is a radioactive agent that binds to rituximab to help with imaging exams), by vein over about 10 minutes. This is so researchers can use a special camera to see where the drug is in your body.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •New diagnosis of low-grade indolent lymphomas Stage I-II. Patients with multiple skin lesions will be eligible provided that the skin is the only site of involvement.
- •Histology includes Indolent cluster of differentiation antigen 20 (CD20)+ lymphomas including: Follicular lymphoma, Extranodal marginal lymphoma of MALT type, Nodal Marginal zone B-cell lymphoma (+/- monocytoid cells), and Splenic marginal B-cell lymphoma (+/- villous lymphocytes).
- •Signed Informed Consent.
- •Age >/= 18 years.
- •Pre-study Zubrod performance status of 0, 1, or
- •Acceptable hematologic status within two weeks prior to patient registration, including: absolute neutrophil count ([segmented neutrophils + bands] x total WBC) >/= 1, 500/mm^3, total lymphocyte count </= 5,000/mm^3 and platelet counts >/= 100,000/mm^
- •Female patients who are not pregnant or lactating.
- •Men and women of reproductive potential who are following accepted birth control methods (as determined by the treating physician, however abstinence is not an acceptable method).
- •Patients determined to have < 25% bone marrow involvement with lymphoma within six weeks of registration (define measurement of a bone marrow aspirate or biopsy).
- •Patient should have at least one lesion measuring >/= 1.5 cm in a single dimension. Measurable cutaneous lesions are allowed.
排除标准
- •Presence of central nervous system (CNS) lymphoma.
- •Patients with HIV or AIDS-related lymphoma.
- •Patients with pleural effusion.
- •Patients with abnormal liver function: total bilirubin > 2.0 mg/dL.
- •Patients with abnormal renal function: serum creatinine > 2.0 mg/dL.
- •Patients who have received prior external beam radiation therapy to > 25% of active bone marrow (involved field or regional).
- •Impaired bone marrow reserve as indicated by < 15% bone marrow cellularity
- •Serious nonmalignant disease or infection which, in the opinion of the investigator and/or the sponsor, would compromise other protocol objectives.
- •Major surgery, other than diagnostic surgery, within four weeks.
- •Evidence of transformation in the latest biopsy.
研究组 & 干预措施
Zevalin
Ibritumomab Tiuxetan (Zevalin) + Rituximab
干预措施: Ibritumomab Tiuxetan (Zevalin) (Drug)
Zevalin
Ibritumomab Tiuxetan (Zevalin) + Rituximab
干预措施: Rituximab (Drug)
结局指标
主要结局
Overall Response Rate (ORR)
时间窗: Up to 5 years; Evaluation at 3-month intervals during Year 1, then every 6 months to Year 4. The median follow-up was 56 months for censored observations.
ORR defined as the percentage of number of complete response (CR), complete response unconfirmed (CRu) or partial response (PR) in patients treated using International Working Group (IWG) revised response criteria for Malignant Lymphoma. ORR to therapy is evaluated after three months using radiographic and clinical parameters to assess response. CR: Complete disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease-related symptoms. CRu: A residual lymph node mass greater than 1.5 cm in greatest transverse diameter that has regressed by more than 75% in the sum of the products of the greatest diameters (SPD). Individual nodes that were previously confluent must have regressed by more than 75% in their SPD compared to the original mass and indeterminate bone marrow. PR: ≥ 50% decrease in SPD of the six largest dominant nodes or nodal masses. No increase in the size of other nodes, liver or spleen and no new sites of disease.
次要结局
- Progression Free Survival (PFS) Rate at 3 Years(Evaluation at 3-month intervals during the first year and then every 6 months until year 3)