Phase II study, multicenter, prospective, open label, preemptive treatment of cytomegalovirus (CMV) infection driven by virologic monitoring and quantification of T CD8pp65/IE-1-IFNgamma+ lymphocytes in allogeneic hematopoietic transplantation

FUNDACION INVESTIGACION HOSPITAL CLINICO DE VALENCIA-INSTITUTO DE INVESTIGACION SANITARIA INCLIVA0 个研究点目标入组 64 人开始时间: 2011年6月14日最近更新: 2018年6月11日

试验速览

暂无简介。

•-Patients older than 18.
•-Patients undergoing any form of allogeneic hematopoietic progenitors transplant.
•-Positive CMV serology in patient and/or donor.
•-Prospective virologic and immune monitoring and systematic posttransplant .
•-First episode of CMV detection in blood by antigemia or PCR before day +100 after transplantation. The level of pp65 antigenemia or PCR-CMV by quantitative PCR used in each participating center is detailed in Annexe II.
•-The first anti-CMV treatment should be made as soon as possible to the positive antigenemia or PCR, with a maximum of 72h after obtaining the positive test to determine the start of treatment.
•-Signing the informed consent to participate in the study.
•-Negative pregnancy test in patients of childbearing age.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 64
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 64

•-Patients receiving autologous or syngeneic transplant.
•-Patients <50 kg in weight.
•-Patients with a history of allergy or hypersensitivity to valganciclovir, ganciclovir or acyclovir. Due to the similarity in chemical structure of valganciclovir, aciclovir and valaciclovir, is likely to occur cross-hypersensitivity reaction between these drugs so Valganciclovir is contraindicated in patients with hypersensitivity to aciclovir and valaciclovir.
•-Disease-tested for this virus is detected when the infection or who are in suspicious box evaluation of CMV disease.
•-Have submitted 1 episode of CMV infection before the current episode.
•-Submit severe liver disease defined by a bilirubin ? 10 mg/dl.
•-Have received foscarnet, ganciclovir, cidofovir or other antiviral agent with activity against CMV clear within 30 days prior to the current episode. The use of acyclovir is allowed, as immunoglobulins.
•-Less than 500 neutrophils / mm3, despite treatment with G-CSF, at the time of starting treatment. Patients with> 500 PMN / mm3 but <1000 neutrophils / mm3 should start treatment with G-CSF for neutrophil count is always> 1000 / mm3.
•-Platelets <25,000 / mm3 despite transfusion.
•-Creatinine clearance <10 ml / min or patients on dialysis. These patients should not receive valganciclovir.
•-Patients who are pregnant or breastfeeding, if they are women of childbearing age should have a negative pregnancy test (urine or serum) and use effective contraception

发起方

FUNDACION INVESTIGACION HOSPITAL CLINICO DE VALENCIA-INSTITUTO DE INVESTIGACION SANITARIA INCLIVA