NCT02581007已完成2 期
Reduced Intensity Conditioning and Transplantation of Partially HLA-Mismatched Peripheral Blood Stem Cells for Patients With Hematologic Malignancies
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Graft Rejection
研究概览
简要总结
This trial will evaluate the safety and efficacy of a reduced intensity allogeneic HSCT from partially HLA-mismatched first-degree relatives utilizing PBSC as the stem cell source. The primary objective of the study is to estimate the incidence of graft rejection and acute GVHD. A secondary objective will be to estimate the incidence of the relapse, NRM, OS, chronic GVHD and EFS.
详细描述
Patients will receive a haploidentical transpalnt using a fludarabine melphalan prepartive regimen. Patients will get cyclophosphamide on days 3 & 4 post-transplant.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •No available matched related or unrelated donor, OR a matched related or unrelated donor will not be available in time frame necessary to perform potentially curative transplant
- •Availability of 3/6 - 5/6 matched (HLA-A, B, DR) related donor (donor must have negative HLA cross-match in host vs. graft direction)
- •Karnofsky status ≥70%
- •One of the following high-risk malignancies:
- •Chronic Myelogenous Leukemia: Chronic myelogenous leukemia in chronic phase, resistant or intolerant to available tyrosine kinase inhibitors; Chronic myelogenous leukemia in accelerated phase; Chronic myelogenous leukemia with blast crisis that has entered into a second chronic phase following induction chemotherapy
- •Acute Myelogenous Leukemia in first or greater remission
- •Myelodysplastic Syndrome at least one of the following: treatment-related; monosmy 7, complex cytogenetics or other high risk karyotype; IPSS score of 1.0 or greater; neutropenia or cytopenia requiring transfusion not responding to therapy; peripheral or BM blast count of <10%; CMML
- •Acute lymphocytic leukemia/lymphoblastic lymphoma: 2nd or subsequent complete remission; first complete remission; marrow blasts <5%, but persistence of minimal residual disease by flow cytometry, cytogenetics, or FISH
- •Chronic Lymphocytic Leukemia/Prolymphocytic Leukemia: previously treated disease that has either relapsed or failed to respond adequately to conventional-dose therapy including purine analogs
- •Hodgkin's or Non-Hodgkin's Lymphoma (including low-grade, mantle cell, and intermediate-grade/diffuse): previously treated disease that has either relapsed or failed to respond adequately to conventional-dose therapy or autologous transplantation
- •Myeloproliferative diseases (myelofibrosis, CMML)
- •Multiple Myeloma with relapse after a prior autologous transplant or eligible for allogeneic HSCT based on other risk factors
排除标准
- •not be excluded on basis of sex, racial, or ethnic backgrounds
- •poor cardiac function: left ventricular ejection fraction <40%
- •poor pulmonary function: FEV1 and FVC <50% predicted
- •poor liver function: bilirubin >2 mg/dl (not due to hemolysis, Gilbert's or primary malignancy)
- •poor renal function: Creatinine >2.0mg/dl or creatinine clearance (calculated creatinine clearance is permitted) < 40 mL/min based on Traditional Cockcroft-Gault formula: 140 - age (yrs) x Smaller of Actual Weight vs. Ideal Body Weight (kg) / 72 x Serum creatinine (mg/dl)
- •HIV-positive
- •prior allogeneic transplant
- •women of childbearing potential who currently are pregnant or who are not practicing adequate contraception
- •any debilitating medical or psychiatric illness which would preclude their giving informed consent or their receiving optimal treatment and follow-up
研究组 & 干预措施
Reduced-Intensity Mismatched Transplant
Experimental
Fludarabine, Melphalan & Post-transplant cyclophosphamide
干预措施: peripheral blood stem cell transplant (Procedure)
Reduced-Intensity Mismatched Transplant
Experimental
Fludarabine, Melphalan & Post-transplant cyclophosphamide
干预措施: Fludarabine (Drug)
Reduced-Intensity Mismatched Transplant
Experimental
Fludarabine, Melphalan & Post-transplant cyclophosphamide
干预措施: Melphalan (Drug)
Reduced-Intensity Mismatched Transplant
Experimental
Fludarabine, Melphalan & Post-transplant cyclophosphamide
干预措施: Cyclophosphamide (Drug)
结局指标
主要结局
Graft Rejection
时间窗: 100 days
Measurement of donor cells vs. recipient cells
次要结局
- GVHD Incidence(100 days)
- Relapse Incidence(2 years)
- Overall Survival(2 years)
研究者
研究点 (1)
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