TAMOVALCIR in Allogenic Hematopoietic Progenitors Transplant

• Status: Completed
• Trial end date: 2009-09-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: PETHEMA Foundation
• Treatments: Ganciclovir; Valganciclovir

Criteria

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