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Observational Study of the Combination of Post-transplant High Dose Cyclophosphamide, Tacrolimus and Mycophenolate Mofetil for the Prevention of Acute Graft-versus-Host Disease in Patients Eligible to Allogeneic Hematopoietic Stem Cell Transplant

2017年9月1日 更新者：Fondazione del Piemonte per l'Oncologia

An Observational Retrospective/Prospective Study of the Combination of Post-transplant High Dose Cyclophosphamide, Tacrolimus and Mycophenolate Mofetil for the Prevention of Acute Graft-versus-Host Disease in Patients Eligible to Allogeneic Hematopoietic Stem Cell Transplant Using Peripheral Blood Stem Cells (PBSC) From Unrelated or Related, HLA-identical or Partially Mismatched Donors

This observational study is proposed to observe the effect of high-dose, post-transplantation cyclophosphamide after a T cell-replete, HLA-matched PBSC graft from an HLA-identical or mismatched donor.

研究概览

地位

未知

条件

详细说明

Allogeneic hematopoietic cell transplantation (HCT) remains the only curative approach for many hematological malignancies. In allogeneic HCT the donor immune system through the donor lymphocytes exerts both a beneficial and detrimental effect. Graft versus host disease (GVHD) represents the major complication and cause of mortality of allogeneic HCT. The principal aim that clinical transplant research must accomplish in the next years is to elaborate a transplant strategy devoid of any GVHD but still capable of generating, through donor lymphocytes, the graft versus tumor effect (GVT). The most used GVHD prophylaxis regimen remains the association of a calcineurin-inhibitor (CNIs) for six months and four low-doses of methotrexate (MTX) but the long length prophylaxis impacts on the process of post-transplant immune reconstitution slowing it down and exposing patients to a high risk of developing severe infections. The use of post-transplant cyclophosphamide looks the most promising among the new approaches to GVHD control. The study design is an observational retrospective/prospective Study in Patients Eligible to Allogeneic Hematopoietic Stem Cell Transplant using Peripheral Blood Stem Cells (PBSC) from unrelated or related, HLA-identical or partially mismatched donors. In case of unrelated donor, donor selection will be done accordingly to Italian Bone Marrow Donor Registry (IBMDR). This protocol and the treatment plan outlined below are limited to the plan or GVHD prevention.

The treatment plan for all patients including pre-conditioning therapy, TBI/chemotherapy, central nervous system prophylaxis and other planned therapies, is described in the primary transplant protocols which the patient has been assigned by the investigational site.

研究类型

观察性的

注册 (预期的)

60

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。

学习联系方式

研究联系人备份

学习地点

  • 意大利
      • Candiolo、意大利、10060
        • 招聘中
        • Fondazione del Piemonte per l'Oncologia
        • 接触：
        • 副研究员：
          • Fabrizio Carnevale Schianca, MD
        • 副研究员：
          • Daniela Caravelli, MD
        • 副研究员：
          • Dario Sangiolo, MD
        • 副研究员：
          • Susanna Gallo, MD
        • 副研究员：
          • Valentina Coha, MD
        • 副研究员：
          • Giovanni Grignani, MD
        • 副研究员：
          • Delia Rota Scalabrini, MD
        • 副研究员：
          • Marco Fizzotti, MD
      • Torino、意大利、10126
        • 尚未招聘
        • Ospedale Regina Margherita
        • 接触：
        • 首席研究员：
          • Franca Fagioli, MD
        • 副研究员：
          • Elena Vassallo, MD
        • 副研究员：
          • Massimo Berger, MD
        • 副研究员：
          • Francesca Nesi, MD
        • 副研究员：
          • Paola Quarello, MD

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 65年 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

取样方法

非概率样本

研究人群

Patients with Hematological Malignancies Eligible to Allogeneic Hematopoietic Stem Cell Transplant using Peripheral Blood Stem Cells (PBSC) from unrelated or related, HLA-identical or partially mismatched donors

描述

Inclusion Criteria:

  1. Patient is scheduled for transplant of 'mobilized' peripheral blood stem cells (PBSC) from a genotypically HLA-unrelated or related identical or partially mismatched stem cell donor.
  2. Patient is ≥ 18 years and ≤ 65 years of age.

  3. Diagnosis of malignancy. Patients will be divided on the basis of their disease in low risk and high risk patients.

    High risk diseases: AML > CR1, ALL > CR1, CML in CP #2, AP or BP, non-Hodgkin's lymphoma > CR2, Hodgkin's lymphoma > CR2, other patient with refractory malignancy Low risk: multiple myeloma (all patients), AML in CR1, myelodysplastic syndrome beyond RA (including CMML) and ALL in CR1.

  4. Patient or legal guardian has signed/dated the informed consent form.
  5. Female patients must have a negative pregnancy test (blood or urine) unless they are prepuberal or surgically sterile.
  6. Estimated Creatinine Clearance ≥ 60 mL/min at time of consent.
  7. Total bilirubin is ≤ 1.5 times the upper limit of normal at time of consent.
  8. SGOT and SGPT are ≤ 2.0 times the upper limit of normal at time of consent.

Exclusion Criteria:

  1. Patient > 65 years of age
  2. Patient has not signed/dated the informed consent form.
  3. Patient is receiving a T-cell depleted hematopoietic stem cell graft.
  4. Pregnant or lactating women
  5. Patient has an acute pulmonary infection suspected on the basis of abnormal chest x-ray.
  6. Patient has an active systemic infection not controlled with anti-microbial therapy.
  7. Patient is a known carrier of any of the Human Immune Deficiency Viruses (HIV-1 or others).

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

  • 观测模型：仅案例
  • 时间观点：其他

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 the observed GVHD rate and infections
大体时间：100 day

Evaluations through day 100 after transplantation will be performed with:

  1. Complete blood count (CBC), including differential and platelet count per standard practice guidelines at the performance site.
  2. Blood chemistries: including sodium, potassium, chloride, bicarbonate (HCO3) or total carbon dioxide (CO2), glucose, blood urea nitrogen (BUN), creatinine, calcium, magnesium, phosphorus, total bilirubin, total protein, albumin, serum glutamic oxaloacetic transaminase (SGOT), lactic dehydrogenase (LDH), alkaline phosphatase per standard practice guidelines at the performance site.

Tacrolimus whole blood concentrations weekly starting on day 6. CMV surveillance, Aspergillus surveillance will be performed per standard practice guidelines at the performance site.

Evaluations after 100 days post-transplant will be completed per standard practice guidelines at each performance site.
100 day

次要结果测量

结果测量
措施说明
大体时间
Overall survival
大体时间：1 years
To determine the overall survival at 1 years (OS)
1 years
Progression-free survival
大体时间：1 years
To determine progression-free survival at 1 years (PFS)
1 years

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

Fondazione del Piemonte per l'Oncologia

调查人员

  • 首席研究员：Massimo Aglietta, md、Fondazione del Piemonte per l'Oncologia
  • 学习椅：Franca Fagioli, MD、Ospedale Regina Margherita
  • 学习椅：Fabrizio Carnevale-Schianca, MD、Fondazione del Piemonte per l'Oncologia

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

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

2013年9月1日

初级完成 (预期的)

2017年12月1日

研究完成 (预期的)

2018年1月1日

研究注册日期

首次提交

2014年11月21日

首先提交符合 QC 标准的

2014年11月21日

首次发布 (估计)

2014年11月25日

研究记录更新

最后更新发布 (实际的)

2017年9月5日

上次提交的符合 QC 标准的更新

2017年9月1日

最后验证

2017年8月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • HDCTX 2013

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

在美国制造并从美国出口的产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

搜索类似试验

赞助者和合作者

医疗条件

药物干预

CROs by country

CROs in Uganda

条件

罕见疾病

药物干预

膳食补充剂

赞助者/合作者

地点

3
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