EUCTR2009-015968-34-DK进行中（未招募）1 期
onmyeloablative Conditioning with Pre- and Post-Transplant Rituximab followed by Related or Unrelated Donor Hematopoietic Cell Transplantation for Patients with Advanced Chronic Lymphocytic Leukemia: A Multi-Center Trial - FHCRC protocol 1840 for C
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 80
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Patients with a diagnosis of CLL (or small lymphocytic lymphoma) or Diagnosis of CLL that progresses to prolymphocytic leukemia (PLL), or T-cell CLL or PLL.
- •2. Patients with B-Cell CLL or PLL who:
- •a. Failed to meet NCI Working Group criteria2 (Appendix I) for complete or partial response after therapy with regimens containing fludarabine (or another nucleoside analog, e.g. 2-CDA, pentostatin) or with disease relapse within 12 months after completing therapy with fludarabine (or another nucleoside analog) containing regimen.
- •b. Failed FCR or PCR combination chemotherapy at any time point.
- •c. Patients with novo or acquired 17p deletion” cytogenetic abnormality. Patients should have received induction chemotherapy but could be transplanted in 1st CR.
- •3.Patients who have suitable HLA-matched related or unrelated donors willing to receive G-CSF, undergo leukopharesis to collect PBMC, and to donate stem cells
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Infection with HIV.
- •2. Active diagnosis of CNS involvement with CLL. For LP requirement, see Appendix O.
- •3. Patients unwilling to use contraceptive techniques before and for 12 months after HCT
- •4. Pregnant women or females who are breastfeeding.
- •5. The addition of cytotoxic agents for cytoreduction” with the exception of tyrosine kinase inhibitors (such as imatinib mesylate), cytokine therapy, hydroxyurea, low dose cytarabine, chlorambucil, or rituxan will not be allowed within three weeks of the initiation of conditioning.
- •6. Active bacterial or fungal infections unresponsive to medical therapy.
- •7. Performance status:
- •a. Karnofsky score < 60 (see Appendix B) for adult patients
- •b. Lansky Play-Performance Score < 40 (Appendix C) for pediatric patients.
- •8. Severe organ dysfunction:
- •a. Cardiovascular:
- •i. Cardiac ejection fraction < 40%. Ejection fraction is required if age > 50 years or there is a history of prior transplant, anthracycline exposure or history of cardiac disease.
- •ii. Poorly controlled hypertension despite multiple antihypertensives.
- •b.Pulmonary:
- •i.DLCO < 40%, TLC <40%, FEV1 <40% and/or requiring continuous supplementary oxygen, or severe deficits in pulmonary function testing as defined by pulmonary consultant service.
- •ii. The FHCRC PI of the study must approve of enrollment of all patients with pulmonary nodules.
- •Patients with clinical or laboratory evidence of liver disease would be evaluated for the cause of liver disease, its clinical severity in terms of liver function, and the degree of portal hypertension. Patients will be excluded if they are found to have fulminant liver failure, cirrhosis of the liver with evidence of portal hypertension, hepatic damage with bridging fibrosis, alcoholic hepatitis, esophageal varices, a history of bleeding esophageal varices, hepatic encephalopathy, uncorrectable hepatic synthetic dysfunction evidenced by prolongation of the prothrombin time, ascites related to portal hypertension, bacterial or fungal liver abscess, biliary obstruction, chronic viral hepatitis with total serum bilirubin >3 mg/dl, or symptomatic biliary disease.
- •9. Patients with active non-hematologic malignancies (except non-melanoma skin cancers).
- •10. Patients with a history of non-hematologic malignancies (except non-melanoma skin cancers) currently in a complete remission, who are less than 5 years from the time of complete remission, and have a >20% risk of disease recurrence
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