NCT00491491已完成3 期
SPINOZA / שפינוזה. Study With Preparatory INduction Of Zevalin in Aggressive Lymphoma. A Randomized Phase 3 Study of BEAM Versus 90Yttrium Ibritumomab Tiuxetan (Zevalin) / BEAM in Patients Requiring Autologous Hematopoietic Stem Cell Transplantation (ASCT) for Relapsed Diffuse Large B-cell Lymphoma
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 9
- 主要终点
- Overall Survival
研究概览
简要总结
The study hypothesis is that the addition of zevalin radioimmunotherapy to the conditioning regimen given prior to BEAM high-dose chemotherapy and autologous stem cell transplantation in patients with aggressive lymphoma will reduced disease recurrence rate and improve overall and disease-free survival.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with CD20 positive diffuse large B-cell lymphoma as confirmed by a pathological biopsy report.
- •Patients who are candidates for autologous stem-cell transplantation due to primary refractory or first relapse of disease.
- •Patients must have chemo-sensitive disease achieving at least partial response (Cheson 2007 criteria) to last chemotherapy.
- •Age ≥ 18 years and age ≤ 70
- •Patients with adequate autologous stem cell collection for transplantation (target ≥ 2.5 x 106 CD34+ cells/kg).
- •Patients must sign written informed consent.
- •Adequate birth control in fertile patients.
- •All prior chemotherapy completed at least three weeks before study treatment.
- •Marrow involvement less than 25% at transplantation, no limitation on blood counts (low platelet count allowed).
- •Negative HIV antibody.
排除标准
- •Chemo-refractory disease as determined by less than partial response (Cheson 2007 Criteria) to last chemotherapy.
- •Two or more relapses after initial response to induction chemotherapy.
- •High-grade transformation from earlier diagnosis of low-grade lymphoma. Patients with "De Novo" Transformed DLBCL, defined as DLBCL only on lymph node biopsy and a discordant marrow with para-trabecular small cells at first diagnosis of lymphoma, are eligible if adherent all other selection criteria.
- •Bilirubin > 3.0 mg/dl, transaminases > 3 times upper normal limit.
- •Creatinine > 2.0 mg/dl.
- •ECOG Performance status >
- •Uncontrolled infection.
- •Pregnancy or lactation.
- •Abnormal lung diffusion capacity (DLCO < 40% predicted).
- •Severe cardiovascular disease; New York Heart Association (NYHA) Functional Classification ≥
- •Active CNS disease involvement.
- •Presence of any other malignancy or history of prior malignancy within 5 years of study entry. Within 5 years, patients treated for Stage I or II cancers are eligible provided they have a life expectancy > 5 years in relation to this prior malignance. The 5-year exclusion rule does not apply to-non melanoma skin tumors and in situ cervical cancer.
- •Pleural effusion or ascites > 1 liter.
- •Known hypersensitivity to rituximab.
- •Psychiatric conditions/disease that impair the ability to give informed consent or to adequately co-operate.
- •Prior radioimmunotherapy.
- •Prior autologous or allogeneic HSCT.
- •Active evidence of Hepatitis B or C infection; Hepatitis B surface antigen positive.
- •Patients who have had prior radiation to the lung will be excluded from the study, although mediastinal irradiation will be permitted if minimal lung is in the treatment volume.
- •Patients who have received >500cGy radiation to the kidneys will be excluded from the study.
研究组 & 干预措施
Z-BEAM
Experimental
ibritumomab tiuxetan (zevalin) BEAM
干预措施: ibritumomab tiuxetan (Drug)
Z-BEAM
Experimental
ibritumomab tiuxetan (zevalin) BEAM
干预措施: BEAM chemotherapy and autologous stem-cell transplantation (Procedure)
standard BEAM
Active Comparator
standard BEAM chemotherapy
干预措施: BEAM chemotherapy and autologous stem-cell transplantation (Procedure)
结局指标
主要结局
Overall Survival
时间窗: 2 years after transplantation
actuarial 2 year survival
次要结局
- Grade III Toxicity(100 days after transplantation)
- Progression-free Survival(2 years after transplantation)
- Clinical Response(100 days after transplantation)
- Hematopoietic Recovery(100 days after transplantation)
- Secondary Malignancies(5 years after transplantation)
研究者
Dr. Avichai Shimoni MD
Dr. Avichai Shimoni
Sheba Medical Center
研究点 (9)
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