A Phase II Study of Tacrolimus and Thymoglobulin, as Graft-versus-Host-Disease Prophylaxis in Patients Undergoing Related Donor Hematopoietic Cell Transplantation
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- Incidence of Acute GVHD
研究概览
简要总结
The primary goal of the study is to determine the incidence and severity of acute Graft versus Host Disease (GVHD) following human leukocyte antigen (HLA) matched related donor Hematopoetic Stem Cell(HSC) transplant in patients with blood related cancers who receive the combination of tacrolimus and Thymoglobulin as GVHD prophylaxis. The investigators also will determine the safety of this combination in the first six months post transplant.
Secondary goals include determining the time to recovery of white blood cells and platelets (engraftment), determining the occurrence of opportunistic infections, defined as infection that occurs in people with weakened immune systems and caused by organisms that do not normally cause disease (fungal infections, pneumocystis carinii pneumonia (PCP), and viral infections), estimating the incidence of chronic GVHD at two years and the overall and disease free survival at two years.
Immune response will be assessed by means of immuno-correlative studies both prior to and at various points after 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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Suitable related donor as determined by the treating physician
- •High resolution molecular HLA typing is mandatory for HLA Class I and II
- •Diagnosis of hematological malignancy
- •Patients with one of the following hematologic malignancies, and felt to be transplant candidates by their treating physician are eligible to enroll on this protocol:
- •Non-Hodgkin lymphoma, any complete remission (CR)/partial remission (PR)
- •Hodgkin disease, any CR/PR/stable disease (SD)
- •Acute myeloid leukemia (AML) or acute lymphoblastic leukemia (ALL) any CR; for non-CR AML or ALL, bone marrow blast < 20% within 4 weeks of transplant and peripheral blood (PB) absolute blast count < 500/μl on the day of initiation of conditioning
- •Myelodysplastic syndrome (MDS), treated or untreated
- •Chronic myelogenous leukemia (CML) in chronic phase or accelerated phase
- •Chronic myelomonocytic leukemia (CMML)
- •Multiple myeloma, any CR/PR/SD
- •Chronic lymphocytic leukemia (CLL) any CR/PR
- •Myelofibrosis and other myeloproliferative disorders; bone marrow blasts less than 20 percent within four weeks of transplant and peripheral blood absolute blast counts less than 500 per microliter on the day of initiation of conditioning
- •Age >= 18 and able to cooperate with oral medication intake
- •Filgrastim (G-CSF) mobilized Peripheral blood stem cells
- •Agrees to participate, and informed consent signed
- •Karnofsky performance status (KPS) >= 60, Eastern Cooperative Oncology Group (ECOG) performance status =< 2
- •Creatinine clearance > 60 mL/min
- •Ejection fraction > 50%
- •Serum bilirubin, alanine aminotransferase (ALT), aspartate aminotransferase (AST) less than 3 X upper limit of normal
- •Forced vital capacity (FVC), forced expiratory volume in one second (FEV1) or diffusion capacity of carbon monoxide (DLCO) > 50% predicted
排除标准
- •Bone marrow or Ex vivo engineered or processed graft (cluster of differentiation [CD]34+ enrichment, T-cell depletion, etc)
- •Patients with documented uncontrolled central nervous system (CNS) disease
- •Active donor or recipient serology positive for human immunodeficiency virus (HIV)
- •Known contraindication to administration of Tacrolimus or Thymoglobulin
- •Active Hepatitis B or C
- •Patients with coronary heart disease (recent myocardial infarctions, angina, cardiac stent, or bypass surgery in the last 6 months) need to be cleared with a stress echocardiogram or nuclear myocardial perfusion stress test, and cardiology consult; all other cardiac history will be at the discretion of the Principal Investigator
- •Oxygen usage at the time of enrollment
- •Patients with clinical ascites
- •Women who are pregnant or nursing
研究组 & 干预措施
Tacrolimus and Thymoglobulin
Tacrolimus and Thymoglobulin, as Graft-versus-Host-Disease Prophylaxis
干预措施: Tacrolimus and Thymoglobulin (Drug)
结局指标
主要结局
Incidence of Acute GVHD
时间窗: Assessed first 6 months post transplant
Cumulative Incidence of grade II-V acute GVHD with relapse or NRM as competing risks
Safety Defined by Serious Adverse Events
时间窗: Assessed first 6 months post transplant
Counted the number of participants that experienced any type of grade 3 or higher toxicity.
Severity of Acute GVHD
时间窗: Assessed first 6 months post transplant
Cumulative Incidence of grade III-V acute GVHD with relapse or NRM as competing risks
次要结局
- Determine Incidence of Opportunistic Infections(Followed for up to two years post transplant)
- Determine Time to Engraftment ("G500")(Followed for up to two years post transplant)
- Estimate Incidence of Chronic GVHD at Two Years(Followed for up to two years post transplant)
- Overall Survival at Two Year,(Followed for up to two years post transplant)
- Determine Time to Engraftment ("PLT20")(Followed for up to two years post transplant)
研究者
Zaid Al-Kadhimi
Principal Investigator
Barbara Ann Karmanos Cancer Institute