NCT01224821已完成2 期
Multicenter, Phase II Dosimetry/Validation Study of 131Iodine-Anti B1 (Murine) Radioimmunotherapy for Chemotherapy Refractory Low Grade B Cell Lymphomas and Low Grade Lymphomas That Have Transformed to Higher Grade Histologies
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 47
- 主要终点
- Number of Participants Who Received the Therapeutic Dose at the Seven Clinical Research Sites
研究概览
简要总结
Study RIT-II-001 is a phase II, multicenter study of the safety, tumor and organ dosimetry, dosimetry methods, and efficacy of Iodine-131 Anti-B1 Antibody for the treatment of patients with low-grade or transformed low-grade non-Hodgkin's lymphoma (NHL). The primary objective of this study is to demonstrate that each site could accurately conduct the whole body dosimetry required for the safe and effective dosing of Iodine-131 Anti-B1 Antibody. Additional objectives of this study are to evaluate the efficacy, dosimetry, and safety of Iodine-131 Anti-B1 Antibody.
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
- •Patients must have a histologically confirmed diagnosis of low-grade non-Hodgkin's B-cell lymphoma or low-grade lymphoma that has transformed to intermediate-, or high-grade lymphoma (transformed lymphoma) according to the Working Formulation for Clinical Usage (IWF A, B, and C).
- •Patients must have evidence that their tumor tissue expresses the CD20 antigen.
- •Patients must have progressive disease of either low-grade or transformed lymphoma within one year of completion of the last chemotherapy regimen administered.
- •Patients must have been previously treated with at least one chemotherapy regimen that included an anthracycline or anthracenedione.
- •Patients must have a performance status of at least 60% on the Karnofsky Scale and anticipated survival of at least three months.
- •Patients must have an absolute granulocyte count of over 1,500 /mm3 and a platelet count above 100,000 /mm3 within seven days of study entry. These blood counts must be sustained without support of hematopoietic cytokines or transfusion of blood products.
- •Patients must have normal renal function (creatinine less than 2.0 mg/dL) and hepatic function (bilirubin less than 2.0 mg/dL) within seven days of study entry.
- •Patients must have bi-dimensionally measurable or evaluable progressive lymphoma disease (at least a 25% increase in tumor size or new sites of disease when compared to the last best disease response). Progression must have occurred within 12 months of the preceding response.
- •Patients must be at least 18 years of age.
- •Patients must give written informed consent and sign an approved informed consent form prior to study entry.
排除标准
- •Patients with more than an average of 25% of the intertrabecular marrow space involved by lymphoma in bone marrow biopsy specimens as assessed microscopically at study entry.
- •Patients who have received cytotoxic chemotherapy, radiation therapy, immunosuppressants, or cytokine treatment within FOUR weeks prior to study entry (six weeks for nitrosourea compounds) or who exhibit persistent clinical evidence of toxicity. The use of steroids must have been discontinued (except maintenance-dose steroids) at least one week prior to study entry and patients must then show evidence of stable or progressive disease.
- •Patients with prior hematologic stem cell transplant following high-dose chemotherapy or chemo/radiotherapy .
- •Patients with obstructive hydronephrosis.
- •Patients with evidence of active infection requiring intravenous antibiotics at the time of study entry.
- •Patients with New York Heart Association class 3 or 4 heart disease or other serious illness that would preclude evaluation.
- •Patients with prior malignancy other than lymphoma, except for adequately treated skin cancer, in situ cervical cancer, or other cancer for which patient has been disease-free for five years.
- •Patients with known HIV infection.
- •Patients with known brain or leptomeningeal metastases.
- •Patients who are pregnant. Patients of child-bearing potential must undergo a pregnancy test within seven days of study entry. Males and females must agree to use effective contraception during the study.
- •Patients with previous allergic reactions to iodine. This does not include IV contrast materials.
- •Patients who were previously given any monoclonal or polyclonal antibodies of any foreign species for either diagnostic or therapeutic purposes. This includes engineered chimeric and humanized antibodies.
- •Patients who previously received radioimmunotherapy.
- •Patients with progressive disease in a field that has been previously irradiated with more than 3500 cGy.
- •Patients who are on another protocol involving non-approved drugs or biologics.
研究组 & 干预措施
Tositumomab and Iodine I-131 Tositumomab
Experimental
Patients receive a dosimetric dose consisting of 450 milligrams (mg) of unlabeled tositumomab (TST, Anti-B1 Antibody) intravenously (IV) followed by 5 milliCurie (mCi) of Iodine I 131 TST IV. Serial whole body sodium iodide probe scintillation counts and whole body conjugate view gamma camera scans obtained approximately 1 hour after administration and then daily for the next 7 days were used to determine the radioactive clearance and the dose of iodine I 131 TST required to deliver a 75 centigray (cGy) therapeutic dose. The therapeutic dose was administered 7-14 days after the dosimetric dose and consisted of TST 450 mg and an activity of Iodine 131 calculated to deliver 75 cGy or 65 cGy of total body irradiation, depending on platelet count, and 35 mg TST.
干预措施: Tositumomab (Anti-B1 Antibody) and Iodine-131 Tositumomab (Biological)
结局指标
主要结局
Number of Participants Who Received the Therapeutic Dose at the Seven Clinical Research Sites
时间窗: Day 1 within one hour of infusion (I) and prior to urination (U); Days 2, 3, and 4 after dosimetric dose (DD) I, following U; Days 6 and 7 after DD I, following U
The dosimetry methods were validated for seven different clinical research sites.
次要结局
- Number of Participants With the Indicated Therapeutic Doses (TD) (Total Body Dose)(Participants were evaluated for up to 142 months in Study 104731 or were followed in the long-term follow-up study (Study 104526) for up to 136.3 months)
- Number of Participants With Confirmed Response (CR, CCR, or PR), as Assessed by the Investigator(Participants were evaluated for up to 142 months in Study 104731 or were followed in the long-term follow-up study (Study 104526) for up to 136.3 months)
- Number of Participants (Par.) With Response (CR, CCR, or PR), as Assessed by the Investigator(Participants were evaluated for up to 142 months in Study 104731 or were followed in the long-term follow-up study (Study 104526) for up to 136.3 months)
- Duration of Response for All Confirmed Responders (CR, CCR, or PR), as Assessed by the Investigator(Participants were evaluated for up to 142 months in Study 104731 or were followed in the long-term follow-up study (Study 104526) for up to 136.3 months)
- Duration of Response for All Confirmed Complete Responders, as Assessed by the Investigator(Participants were evaluated for up to 142 months in Study 104731 or were followed in the long-term follow-up study (Study 104526) for up to 136.3 months)
- Duration of Response for All Unconfirmed Complete Responders, as Assessed by the Investigator(Participants were evaluated for up to 142 months in Study 104731 or were followed in the long-term follow-up study (Study 104526) for up to 136.3 months)
- Duration of Response for All Unconfirmed Responders (CR, CCR, or PR), as Assessed by the Investigator(Participants were evaluated for up to 142 months in Study 104731 or were followed in the long-term follow-up study (Study 104526) for up to 136.3 months)
- Duration of Response for All Confirmed Clinical Complete Responders, as Assessed by the Investigator(Participants were evaluated for up to 142 months in Study 104731 or were followed in the long-term follow-up study (Study 104526) for up to 136.3 months)
- Time to Disease Progression or Death for Responders, as Assessed by the Investigator(Participants were evaluated for up to 142 months in Study 104731 or were followed in the long-term follow-up study (Study 104526) for up to 136.3 months)
- Time to Disease Progression or Death for All Participants, as Assessed by the Investigator(Participants were evaluated for up to 142 months in Study 104731 or were followed in the long-term follow-up study (Study 104526) for up to 136.3 months)
- Number of Participants With CR and CCR, as Assessed by the Investigator(Participants were evaluated for up to 142 months in Study 104731 or were followed in the long-term follow-up study (Study 104526) for up to 136.3 months)
- Number of Participants With Confirmed CR and CCR, as Assessed by the Investigator(Participants were evaluated for up to 142 months in Study 104731 or were followed in the long-term follow-up study (Study 104526) for up to 136.3 months)
- Duration of Response for All Unconfirmed Clinical Complete Responders, as Assessed by the Investigator(Participants were evaluated for up to 142 months in Study 104731 or were followed in the long-term follow-up study (Study 104526) for up to 136.3 months)
- Median Time to Treatment Failure for All Participants(Participants were evaluated for up to 142 months in Study 104731 or were followed in the long-term follow-up study (Study 104526) for up to 136.3 months)
- Overall Survival(Participants were evaluated for up to 142 months in Study 104731 or were followed in the long-term follow-up study (Study 104526) for up to 136.3 months)
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