Study for the treatment of cytomegalovirus infection, in transplanted patients

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

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2011-001449-34-ES

Enrollment

Registered

2011-06-14

Start date

2011-08-19

Completion date

Unknown

Last updated

2018-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cytomegalovirus infection in patients treated with hematopoietic allogenic transplant MedDRA version: 13.1 Level: HLT Classification code 10011827 Term: Cytomegaloviral infections System Organ Class: 10021881 - Infections and infestations

Interventions

Trade Name: CYMEVENE Product Name: GANCICLOVIR Pharmaceutical Form: Injection INN or Proposed INN: GANCICLOVIR SODICO Other descriptive name: GANCICLOVIR SODIUM Concentration unit: mg/ml milligram(s)/

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: -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

Exclusion criteria

Exclusion criteria: -Patients receiving autologous or syngeneic transplant. -Patients 500 PMN / mm3 but 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

Design outcomes

Primary

Measure	Time frame
Main Objective: To determine whether a strategy of early treatment of CMV infection post hematopoietic allogeneic transplant, guided by virological monitoring and quantification of T CD8pp65/IE-1-IFNgamma+ lymphocytes is at least the same or more effective than the standard strategy (historical control group).;Secondary Objective: Compare two strategies for toxicity (especially myelo and nephrotoxicity) and duration of antiviral treatment. Secondary endpoints of safety assessment: percentage of patients who: - Having achieved hematologic recovery, develop neutropenia of <1.0 x109/L and <0.5 x109/L, during the first 100 days of TPH. - Develop nephrotoxicity in the first 100 days of TPH, defined as doubling of baseline creatinine figure, or rise by at least 1 mg/dl. - Develop CMV disease during treatment or within following 2 months. - Develop antigenemia/PCR positive in blood in the 2 months following treatment completion. - Frequency and type of infections during treatment and 2 months follow up. Secondary endpoint evaluation of efficacy: - Total days of antiviral treatment;Primary end point(s): Primary endpoint of efficacy: percentage of patients with negativity of CMV in blood at the end of treatment (assessment at 7, 14, 21 and 28 days) and no relapse within 2 months after completion of treatment, measured from the initiation of therapy and after completion of treatment administered. This figure is compared with that in the historical control group treated as standard in the institutions participating in this project.;Timepoint(s) of evaluation of this end point: Percentage of patients with negativity of CMV in blood at the end of treatment (assessment at 7, 14, 21 and 28 days) and no relapse within 2 months after completion of treatment, measured from the initiation of therapy and after completion of treatment administered.	—

Measure

Time frame

Main Objective: To determine whether a strategy of early treatment of CMV infection post hematopoietic allogeneic transplant, guided by virological monitoring and quantification of T CD8pp65/IE-1-IFNgamma+ lymphocytes is at least the same or more effective than the standard strategy (historical control group).;Secondary Objective: Compare two strategies for toxicity (especially myelo and nephrotoxicity) and duration of antiviral treatment. Secondary endpoints of safety assessment: percentage of patients who: - Having achieved hematologic recovery, develop neutropenia of <1.0 x109/L and <0.5 x109/L, during the first 100 days of TPH. - Develop nephrotoxicity in the first 100 days of TPH, defined as doubling of baseline creatinine figure, or rise by at least 1 mg/dl. - Develop CMV disease during treatment or within following 2 months. - Develop antigenemia/PCR positive in blood in the 2 months following treatment completion. - Frequency and type of infections during treatment and 2 months follow up. Secondary endpoint evaluation of efficacy: - Total days of antiviral treatment;Primary end point(s): Primary endpoint of efficacy: percentage of patients with negativity of CMV in blood at the end of treatment (assessment at 7, 14, 21 and 28 days) and no relapse within 2 months after completion of treatment, measured from the initiation of therapy and after completion of treatment administered. This figure is compared with that in the historical control group treated as standard in the institutions participating in this project.;Timepoint(s) of evaluation of this end point: Percentage of patients with negativity of CMV in blood at the end of treatment (assessment at 7, 14, 21 and 28 days) and no relapse within 2 months after completion of treatment, measured from the initiation of therapy and after completion of treatment administered.

—

Secondary

Measure	Time frame
Secondary end point(s): Compare two strategies for toxicity (especially myelo and nephrotoxicity) and duration of antiviral treatment. Secondary endpoints of safety assessment: percentage of patients who: -Having achieved hematologic recovery, develop neutropenia of <1.0 x109 / L and <0.5 x109 / L, during the first 100 days of TPH. -Develop nephrotoxicity in the first 100 days of TPH, defined as doubling of baseline creatinine figure, or rise by at least 1 mg/dl. -Develop CMV disease during treatment or within 2 following months. -Develop antigenemia / PCR positive in blood in the 2 months following treatment completion. -Frequency and type of infections during treatment and 2 months follow up. Secondary endpoint evaluation of efficacy: -Total days of antiviral treatment.;Timepoint(s) of evaluation of this end point: Secondary endpoints of safety assessment: percentage of patients who: -Having achieved hematologic recovery, develop neutropenia of <1.0 x109 / L and <0.5 x109 / L, during the first 100 days of TPH. -Develop nephrotoxicity in the first 100 days of TPH, defined as doubling of baseline creatinine figure, or rise by at least 1 mg/dl. -Develop CMV disease during treatment or within 2 following months. -Develop antigenemia / PCR positive in blood in the 2 months following treatment completion. -Frequency and type of infections during treatment and 2 months follow up. Secondary endpoint evaluation of efficacy: -Total days of antiviral treatment.	—

Measure

Time frame

Secondary end point(s): Compare two strategies for toxicity (especially myelo and nephrotoxicity) and duration of antiviral treatment. Secondary endpoints of safety assessment: percentage of patients who: -Having achieved hematologic recovery, develop neutropenia of <1.0 x109 / L and <0.5 x109 / L, during the first 100 days of TPH. -Develop nephrotoxicity in the first 100 days of TPH, defined as doubling of baseline creatinine figure, or rise by at least 1 mg/dl. -Develop CMV disease during treatment or within 2 following months. -Develop antigenemia / PCR positive in blood in the 2 months following treatment completion. -Frequency and type of infections during treatment and 2 months follow up. Secondary endpoint evaluation of efficacy: -Total days of antiviral treatment.;Timepoint(s) of evaluation of this end point: Secondary endpoints of safety assessment: percentage of patients who: -Having achieved hematologic recovery, develop neutropenia of <1.0 x109 / L and <0.5 x109 / L, during the first 100 days of TPH. -Develop nephrotoxicity in the first 100 days of TPH, defined as doubling of baseline creatinine figure, or rise by at least 1 mg/dl. -Develop CMV disease during treatment or within 2 following months. -Develop antigenemia / PCR positive in blood in the 2 months following treatment completion. -Frequency and type of infections during treatment and 2 months follow up. Secondary endpoint evaluation of efficacy: -Total days of antiviral treatment.

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Countries

Spain

Contacts

Public ContactUNIDAD ENSAYOS CLINICOS

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

fundacioninvestigacion_hcv@gva.es34963862894

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026