EUCTR2011-000088-28-DK进行中（未招募）1 期
A Randomized Phase III Study to Determine the Most Promising Postgrafting Immunosuppression for Prevention of Acute GVHD after Unrelated Donor Hematopoietic Cell Transplantation using Nonmyeloablative Conditioning for Patients with Hematologic Malignancies A Multi-Center Trial
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 300
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
- •Ages >50 years with hematologic malignancies treatable by unrelated HCT.
- •Ages <= 50 years of age with hematologic diseases treatable by allogeneic HCT who through pre-existing medical conditions or prior therapy are considered to be at high risk for regimen related toxicity associated with a high dose transplant (>40% risk of TRM).
- •Ages <= 50 years of age with chronic lymphocytic leukemia (CLL) (these patients do not require patient review committee approvals).
- •Ages <= 50 years of age with hematologic diseases treatable by allogeneic HCT who refuse a high-dose HCT.
- •The following diseases will be permitted:
- •1) Aggressive nonHodgkin lymphomas (NHL) and Other Histologies Such as Diffuse large B cell NHL– not eligible for autologous HCT, not eligible for high-dose allogeneic HCT, or after failed autologous HCT.
- •2) Mantle Cell NHL -may be treated in first CR.
- •3) Low grade NHL– with < 6 month duration of CR between courses of conventional therapy
- •4) CLL – must have either 1) failed to meet NCI Working Group criteria for complete or partial response after therapy with a regimen containing FLU (or another nucleoside analog, e.g. 2-CDA, pentostatin) or experience disease relapse within 12 months after completing therapy with a regimen containing FLU (or another nucleoside analog); 2) failed FLU-CY-Rituximab (FCR) combination chemotherapy at any time point; or 3) have 17p deletion” cytogenetic abnormality. Patients should have received induction chemotherapy but could be transplanted in 1st CR; or 4) 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.
- •5) Hodgkin Lymphoma – must have received and failed frontline therapy.
- •6) Multiple Myeloma – must have received prior chemotherapy. Consolidation of chemotherapy by autografting prior to nonmyeloablative HCT is permitted.
- •7) Acute Myeloid Leukemia (AML)– must have < 5% marrow blasts at the time of transplant.
- •8) Acute Lymphocytic Leukemia (ALL) – must have <5% marrow blasts at the time of transplant.
- •9) Chronic Myeloid Leukemia (CML)– Patients in CP1 must have failed or be intolerant of TKIs. Patients beyond CP1 will be accepted if theyhave <5% marrow blasts at time of transplant. 10) Myelodysplasia(MDS)/Myeloproliferative Syndrome (MPS) – Patients must have <5% marrow blasts at time of transplant.
- •11) Waldenstrom’s Macroglobulinemia – must have failed 2 courses of therapy.
- •Are the trial subjects under 18? no
- •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) Patients with rapidly progressive intermediate or high grade NHL.
- •2) Patients with a diagnosis of CMML.
- •3) Patients with RAEB who have not received myelosuppressive chemotherapy i.e. induction chemotherapy.
- •4) CNS involvement with disease refractory to intrathecal chemotherapy.
- •5) Presence of circulating leukemic blasts (in the peripheral blood) detected by standard pathology for patients with AML, MDS, ALL or CML.
- •6) Fertile men or women unwilling to use contraceptive techniques during and for 12 months following treatment.
- •7) Females who are pregnant or breast-feeding.
- •8) Patients with active non-hematological malignancies (except non-melanoma skin cancers) or those with non-hematological malignancies (except non-melanoma skin cancers) who have been rendered with no evidence of disease, but have a greater than 20% chance of having disease recurrence within 5 years.
- •9) Fungal infections with radiological progression after receipt of amphotericin B or active triazole for greater than 1 month.
- •10) Organ dysfunction.
- •a. Cardiac ejection fraction < 35%. Ejection fraction is required if age > 50 years or there is a history of anthracycline exposure or history of cardiac disease.
- •b. Pulmonary:
- •i) DLCO < 40%, TLC <40%, FEV1 <40% and/or receiving supplementary continuous oxygen.
- •ii) The FHCRC PI of the study must approve of enrollment of all patients with pulmonary nodules.
- •c. Liver function abnormalities: 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.
- •11) Karnofsky scores < 60 or Lansky Score <50
- •12) Patient has poorly controlled hypertension and on multiple antihypertensives
- •13) HIV positive patients.
- •14) Active bacterial or fungal infections unresponsive to medical therapy.
- •15) All patients receiving antifungal therapy voriconazole, posaconazole, or fluconazole and who are then randomized to ARM2 or ARM 3 must have sirolimus reduced.
- •16) The addition of cytotoxic agents for cytoreduction” with the exception of tyrosine kinase inhibitors (such as imatinib), cytokine therapy, hydroxyurea, low dose cytarabine, chlorambucil, or rituxan will not be allowed within three weeks of the initiation of conditioning.
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