TAMOVALCIR in Allogenic Hematopoietic Progenitors Transplant

PETHEMA Foundation

Status and phase

Completed

Phase 2

Conditions

Cytomegalovirus Infection

Treatments

Drug: Valganciclovir

Study type

Interventional

Funder types

Other

Identifiers

NCT00386412

TAMOVALCIR in alogenic

2005-002813-19.

Details and patient eligibility

About

PRINCIPAL ENDPOINT To value valganciclovir efficacy in advance treatment of CMV in patients received allogenic transplant with a uniform treatment.

SECONDARY ENDPOINT To value valganciclovir security in advance treatment of CMV in in patients received allogenic transplant with a uniform treatment.

The security will be valued by the % of patients that:

Will have negative CMV Neutropenia <1000 neutrophils/mm3 or <500 neutrophils/mm3 in the first 35 days of treatment - follow-up Renal toxicity in the first 35 days of treatment - follow-up (defined by elevated creatinine >1mg/dL or twice the basal value) CMV illness during the treatment or in the next 2 months Blood Antigenemia / PCR positive in the next 2months of treatment

This dates Hill be compared with a patients control group treated with intravenous valganciclovir

Full description

Clinical trial with a drug in new conditions of use

Enrollment

132 estimated patients

Sex

All

Ages

2+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patients > 18 years old
Any patients with allogenic TPH
Following in post-TPH with antigenemia or PCR-CMV
CMV in blood test detected by antigenemia or PCR before the day 180 post-TPH
The beginning of treatment must be Duch early as possible. Maximum in the 72 hours from the antigenemia or PCR-CMV detection
Be the first or second time of a CMV infection
Sign the informed consent
Pregnancy negative test in fertile age patients

Exclusion criteria

Patients received auto or syngenic TPH
Patients <50 kg weight
Known allergy or hypersensibility patients to valganciclovir, ganciclovir or aciclovir
Digestive intolerant: nauseous, vomit and or diarrhea that could difficult oral administration of valganciclovir
Patients that presents CMV infection or that is being evaluated for suspected CMV
Patients that have presented >2 CMV infection episode, before the current one
Severe liver disease defined by bilirubin ≥ 10mg/dL
Treated with: foscarnet, ganciclovir, cidofovir or another antiviral drug active to CMV, in the previous 30 days at the current episode
Neutrophils < 500 /µL at the beginning of valganciclovir treatment. Patients with >500 PMN/µL and < 1000/µL must start a G-CSF treatment to get neutrophils value > 1000/µL
Platelets < 25/mm3 even receiving transfusion
Clearance Creatinine < 10mL/min or dialysed patients
Pregnancy or lactant women
Other contraindication detailed in the "filling card"
Previous inclusión in this study at the treated group. Is allowed that a patient participate as a control case and after that receive valganciclovir treatment in after CMV episode