NCT05417971招募中不适用
A Phase II Trial of Reduced Intensity Fludarabine and Total Body Irradiation-Based Conditioning Prior to Haplo-Identical Transplantation for Patients With Hematologic Malignancies
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Compare the time to recovery of circulating neutrophils and platelets of all patients to determine incidence of graft rejection
研究概览
简要总结
This trial will evaluate the safety and efficacy of RIC HIDT transplant protocol following fludarabine and intermediate-dose TBI 800 cGy utilizing PBSC as the stem cell source.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Availability of 3/6 - 5/6 matched related donor with a negative HLA-cross match in the host vs. graft direction willing to donate peripheral blood stem cells
- •KPS >/= 70%
- •Hematologic malignancy requiring allogeneic transplantation, with a predicted high risk of relapse following non-myeloablative, low intensity conditioning.
排除标准
- •Poor cardiac function (LVEF <45%)
- •Poor pulmonary function (FEV, FVC, DLCO <60%)
- •Poor liver function (bilirubin >/= 2.5mg/dL; AST or ALT >3xULN)
- •Poor renal function (creatinine clearance <40mL/min)
- •HIV-positive; active HepB or HepC
- •Uncontrolled infection
- •Pregnant female or not able to practice adequate contraception
- •Debilitating medical or psychiatric illness which would preclude their giving informed consent
结局指标
主要结局
Compare the time to recovery of circulating neutrophils and platelets of all patients to determine incidence of graft rejection
时间窗: 30 days after transplant
次要结局
- Number of patients with evidence of graft versus host disease as assessed by weekly progress notes after transplant(36 months after transplant)
- Number of patients who are still alive as assessed by survival status at certain timepoints after transplant(36 months after transplant)
- Number of participants with responses to treatment as assessed by labs, bone marrow biopsies and radiological scans at certain timepoints after transplant(36 months after transplant)
- Number of participants with treatment-related adverse events as assessed by CTCAE v.5.0(90 days after transplant)
- Number of patients with relapsed disease as assessed by labs, bone marrow biopsies and radiological scans at certain timepoints after transplant(36 months after transplant)
- Number of participants who died in the absence of relapse or progression as assessed by survival status at certain timepoints after transplant(1 year after transplant)
研究者
研究点 (2)
Loading locations...
相似试验
已完成
2 期
Reduced Intensity Flu/Mel/TBI Conditioning for HAPLO HCT Patients With Hematologic MalignanciesBiphenotypic Acute LeukemiaUndifferentiated LeukemiaMyelodysplastic SyndromesMyeloproliferative NeoplasmRelapsed Large Cell LymphomaAcute Myeloid LeukemiaBurkitt LymphomaRelapsed T-Cell LymphomaRelapsed Chronic Lymphocytic LeukemiaRelapsed Small Lymphocytic LymphomaRelapsed Marginal B-cell LymphomaRelapsed Follicular LymphomaLymphoplasmacytic LymphomaAcute Lymphoblastic LeukemiaProlymphocytic LeukemiaMantle Cell LymphomaHodgkin LymphomaChronic Myelogenous LeukemiaNCT04191187H. Lee Moffitt Cancer Center and Research Institute34
终止
2 期
Combination Therapy With Fludarabine, Mitoxantrone and Rituximab in Mantle Cell LymphomaMantle Cell LymphomaNCT00183989University of Southern California30
终止
2 期
Fludarabine in Combination With Daunorubicin and Cytarabine Liposome in Newly-diagnosed Acute Myeloid Leukemia.Acute Myeloid Leukemia, AdultAML, AdultAMLNCT04425655University of California, San Diego2
已完成
2 期
FM 140 vs FM100 Study in Patients With Multiple MyelomaMultiple MyelomaNCT00505895M.D. Anderson Cancer Center52
已完成
2 期
Fludarabine, Rituximab, and Alemtuzumab for B-Chronic Lymphocytic Leukemia or Small Lymphocytic LymphomaLymphoma, Small LymphocyticLymphocytic Leukemia, ChronicNCT00143065Ohio State University Comprehensive Cancer Center8