NCT00997386已完成2 期
A Phase II Study of Reduced-Intensity Allogeneic Peripheral Blood Stem Cell Transplantation (PBSCT) for Treatment of Hematologic Malignancies and Hematopoietic Failure States
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
- 16
- 试验地点
- 1
- 主要终点
- Number of Participants With Presence of Donor Lymphohematopoietic Chimerism (Defined as at Least 50% Donor Cells in the Peripheral Blood) in Peripheral Blood by Day +100 (i.e., 100 Days After Allogeneic PBSCT).
研究概览
简要总结
The purpose of this study is to look at whether the combination of lower-dose chemotherapy with two chemotherapy (anti-cancer) drugs, called busulfan and melphalan, and an antibody medication called alemtuzumab (Campath®), can prevent rejection of donor blood stem cells so that those cells take hold and build a healthy new blood cell factory after transplant. The study will also look at the safety of the combination of drugs and of the transplant of peripheral blood stem cells from a healthy relative or an unrelated donor.
详细描述
Transplantation of related or unrelated allogeneic peripheral blood stem cells (PBSCs) after administration of a reduced-intensity regimen of busulfan, melphalan and alemtuzumab will be associated with satisfactory engraftment and acceptable post-transplant non-relapse mortality.
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
- •Age 50 to 75 years or age 18 to 49 with one or more of these risk factors: prior autologous, allogeneic or syngeneic HCT (Hematopoietic cell transplantation); not in first complete remission or first chronic phase; and/or presence of one or more medical conditions that would place the subject at high risk such as heart and kidney disease.
- •Subjects with hematologic cancers must have received at least one previous course of chemotherapy or biological therapy. In other words, the subject cannot enroll in this trial for initial treatment of the disease.
- •Availability of a healthy related or unrelated volunteer allogeneic donor.
排除标准
- •Eligible for another study or standard of care treatment that offers higher probability of cure or long-term control of subject's disease.
- •Severe abnormal function of organs such as heart, kidneys, liver.
- •Untreated or progressive central nervous system involvement by the disease.
- •Subject is pregnant or breast-feeding.
- •Performance score is below 50: at the least, requires considerable assistance and frequent medical care.
- •Positive for the HIV [AIDS] virus
- •Life expectancy less than 12 weeks with conventional treatments.
- •For subjects capable of having children, refusal to practice birth control while on this study and for at least 12 months after PBSCT or after stopping post-transplant immunosuppressive treatments, whichever occurs later.
研究组 & 干预措施
busulfan, and melphalan, and alemtuzumab
Experimental
Three drug regimen using busulfan, and melphalan, and alemtuzumab.
干预措施: busulfan, and melphalan, and alemtuzumab (Drug)
结局指标
主要结局
Number of Participants With Presence of Donor Lymphohematopoietic Chimerism (Defined as at Least 50% Donor Cells in the Peripheral Blood) in Peripheral Blood by Day +100 (i.e., 100 Days After Allogeneic PBSCT).
时间窗: Day +100
To determine the efficacy of related or unrelated allogeneic PBSC transplantation (PBSCT) using a preparative regimen of busulfan, melphalan and alemtuzumab, as measured by durable donor lymphohematopoietic cell engraftment. The primary efficacy endpoint is the presence of donor lymphohematopoietic chimerism (defined as at least 50% donor cells in the peripheral blood) in peripheral blood by day +100 (i.e., 100 days after allogeneic PBSCT).
次要结局
- Number of Participants With Relapse-free Survival.(Day +100)
- Number of Participants With Event-free Survival.(Day +100)
- Number of Participants With Overall Survival.(Day +100)
研究者
研究点 (1)
Loading locations...
相似试验
终止
2 期
Low-Intensity Chemotherapy and Blinatumomab in Treating Patients With Philadelphia Chromosome Negative Relapsed or Refractory Acute Lymphoblastic LeukemiaPhiladelphia Chromosome NegativeRecurrent B Acute Lymphoblastic LeukemiaRefractory B Acute Lymphoblastic LeukemiaNCT03518112M.D. Anderson Cancer Center6
已完成
2 期
Fludarabine Phosphate, Melphalan, and Low-Dose Total-Body Irradiation Followed by Donor Peripheral Blood Stem Cell Transplant in Treating Patients With Hematologic MalignanciesAccelerated Phase Chronic Myelogenous LeukemiaAdult Acute Lymphoblastic Leukemia in RemissionAdult Acute Myeloid Leukemia in RemissionAdult Acute Myeloid Leukemia With 11q23 (MLL) AbnormalitiesAdult Acute Myeloid Leukemia With Del(5q)Adult Acute Myeloid Leukemia With Inv(16)(p13;q22)Adult Acute Myeloid Leukemia With t(15;17)(q22;q12)Adult Acute Myeloid Leukemia With t(16;16)(p13;q22)Adult Acute Myeloid Leukemia With t(8;21)(q22;q22)Adult Grade III Lymphomatoid GranulomatosisAdult Nasal Type Extranodal NK/T-cell LymphomaAngioimmunoblastic T-cell LymphomaBurkitt LymphomaChildhood Acute Lymphoblastic Leukemia in RemissionChildhood Acute Myeloid Leukemia in RemissionChildhood Chronic Myelogenous LeukemiaChildhood Diffuse Large Cell LymphomaAnaplastic Large Cell LymphomaChildhood Grade III Lymphomatoid GranulomatosisChildhood Immunoblastic Large Cell LymphomaChildhood Myelodysplastic SyndromesChildhood Nasal Type Extranodal NK/T-cell LymphomaChronic Phase Chronic Myelogenous LeukemiaCongenital Amegakaryocytic ThrombocytopeniaDiamond-Blackfan AnemiaExtranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid TissueHepatosplenic T-cell LymphomaMyelodysplastic/Myeloproliferative Neoplasm, UnclassifiableNodal Marginal Zone B-cell LymphomaParoxysmal Nocturnal HemoglobinuriaPeripheral T-cell LymphomaJuvenile Myelomonocytic LeukemiaPreviously Treated Myelodysplastic SyndromesRecurrent Adult Acute Lymphoblastic LeukemiaRecurrent Adult Acute Myeloid LeukemiaRecurrent Adult Burkitt LymphomaRecurrent Adult Diffuse Large Cell LymphomaRecurrent Adult Diffuse Mixed Cell LymphomaRecurrent Adult Diffuse Small Cleaved Cell LymphomaRecurrent Adult Grade III Lymphomatoid GranulomatosisRecurrent Adult Hodgkin LymphomaRecurrent Adult Immunoblastic Large Cell LymphomaRecurrent Adult Lymphoblastic LymphomaRecurrent Adult T-cell Leukemia/LymphomaRecurrent Childhood Acute Lymphoblastic LeukemiaRecurrent Childhood Acute Myeloid LeukemiaRecurrent Childhood Anaplastic Large Cell LymphomaRecurrent Childhood Grade III Lymphomatoid GranulomatosisRecurrent Childhood Large Cell LymphomaRecurrent Childhood Lymphoblastic LymphomaChronic Myelomonocytic LeukemiaPost-transplant Lymphoproliferative DisorderRecurrent Childhood Small Noncleaved Cell LymphomaRecurrent Cutaneous T-cell Non-Hodgkin LymphomaRecurrent Grade 1 Follicular LymphomaRecurrent Grade 2 Follicular LymphomaRecurrent Grade 3 Follicular LymphomaRecurrent Mantle Cell LymphomaRecurrent Marginal Zone LymphomaRecurrent Mycosis Fungoides/Sezary SyndromeRecurrent Small Lymphocytic LymphomaRecurrent/Refractory Childhood Hodgkin LymphomaRefractory Chronic Lymphocytic LeukemiaRefractory Hairy Cell LeukemiaRefractory Multiple MyelomaSecondary Acute Myeloid LeukemiaSecondary Myelodysplastic SyndromesShwachman-Diamond SyndromeSplenic Marginal Zone LymphomaT-cell Large Granular Lymphocyte LeukemiaWaldenstrom MacroglobulinemiaWiskott-Aldrich SyndromeSevere Combined ImmunodeficiencySecondary MyelofibrosisAplastic AnemiaPrimary MyelofibrosisPolycythemia VeraSevere Congenital NeutropeniaNCT01529827Roswell Park Cancer Institute94
撤回
2 期
A Phase II Study to Evaluate Low-Dose Fractionated Radiotherapy (LDFRT)Squamous Cell Carcinoma of the Head and NeckNCT01820312University of Arkansas
进行中（未招募）
2 期
Lower-Dose Chemoradiation in Treating Patients With Early-Stage Anal Cancer, the DECREASE StudyAnal Basaloid CarcinomaAnal Canal Cloacogenic CarcinomaAnal Canal Squamous Cell CarcinomaAnal Margin Squamous Cell CarcinomaStage I Anal Cancer AJCC v8Stage IIA Anal Cancer AJCC v8NCT04166318ECOG-ACRIN Cancer Research Group252
招募中
2 期
Testing the Combination of Two Approved Chemotherapy Drugs and Radiation Prior to Surgery in Localized Pancreatic CancerPancreas AdenocarcinomaResectable Pancreatic CancerNCT03492671Loma Linda University30