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Tacrolimus and Thymoglobulin, as GvHD Prophylaxis in Patients Undergoing Related Donor HCT

2018年5月16日 更新者：Zaid Al-Kadhimi、Barbara Ann Karmanos Cancer Institute

A Phase II Study of Tacrolimus and Thymoglobulin, as Graft-versus-Host-Disease Prophylaxis in Patients Undergoing Related Donor Hematopoietic Cell Transplantation

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.

研究概览

地位

完全的

条件

干预/治疗

研究类型

介入性

注册 (实际的)

21

阶段

  • 阶段2

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 美国
    • Michigan
      • Detroit、Michigan、美国、48201
        • Barbara Ann Karmanos Cancer Institute

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 70年 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：不适用
  • 介入模型：单组作业
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
实验性的：Tacrolimus and Thymoglobulin
Tacrolimus and Thymoglobulin, as Graft-versus-Host-Disease Prophylaxis
药品：Tacrolimus and Thymoglobulin
Intravenous Tacrolimus 0.03 mg/kg/d, beginning day -3, where day 0 is the day of stem cell infusion or "transplant." Intravenous tacrolimus will be discontinued once the participant starts eating, and the drug will then be given orally at a dose of approximately 4 times the intravenous dose. Tacrolimus will be discontinued starting 100 days after transplant unless signs of acute and chronic GVHD develop or if severe toxicity occurs. Thymoglobulin will be given 0.5 mg/kg day-3, Thymoglobulin 1.5 mg/kg day -2, Thymoglobulin 2.5 mg/kg day -1. Thymoglobulin will be given intravenously over 6 hours.
其他名称：
  • 程序®

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Incidence of Acute GVHD
大体时间：Assessed first 6 months post transplant
Cumulative Incidence of grade II-V acute GVHD with relapse or NRM as competing risks
Assessed first 6 months post transplant
Safety Defined by Serious Adverse Events
大体时间：Assessed first 6 months post transplant
Counted the number of participants that experienced any type of grade 3 or higher toxicity.
Assessed first 6 months post transplant
Severity of Acute GVHD
大体时间：Assessed first 6 months post transplant
Cumulative Incidence of grade III-V acute GVHD with relapse or NRM as competing risks
Assessed first 6 months post transplant

次要结果测量

结果测量
措施说明
大体时间
Determine Incidence of Opportunistic Infections
大体时间：Followed for up to two years post transplant
Followed for up to two years post transplant
Estimate Incidence of Chronic GVHD at Two Years
大体时间：Followed for up to two years post transplant
Cumulative Incidence of chronic GVHD with relapse or NRM as competing risks
Followed for up to two years post transplant
Overall Survival at Two Year,
大体时间：Followed for up to two years post transplant
Followed for up to two years post transplant
Determine Time to Engraftment ("G500")
大体时间：Followed for up to two years post transplant
The number of days until engraftment ("G500")
Followed for up to two years post transplant
Determine Time to Engraftment ("PLT20")
大体时间：Followed for up to two years post transplant
The number of days until engraftment ("PLT20")
Followed for up to two years post transplant

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Barbara Ann Karmanos Cancer Institute

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2010年11月1日

初级完成 (实际的)

2013年10月1日

研究完成 (实际的)

2013年10月1日

研究注册日期

首次提交

2010年11月21日

首先提交符合 QC 标准的

2010年11月22日

首次发布 (估计)

2010年11月23日

研究记录更新

最后更新发布 (实际的)

2018年6月18日

上次提交的符合 QC 标准的更新

2018年5月16日

最后验证

2018年5月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • WSU 2009-095

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