TAMOVALCIR in Allogenic Hematopoietic Progenitors Transplant

Cytomegalovirus Infection Clinical Trial

Official title:

Phase II, Multicentric, Prospective and Opened Clinical Trial of Advance Valganciclovir Treatment of CMV in Allogenic Hematopoietic Progenitors Transplant

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00386412
• Other study ID #: 2005-002813-19.
• Secondary ID: TAMOVALCIR in al
• Status: Completed
• Phase: Phase 2
• First received: October 9, 2006
• Last updated: September 17, 2009
• Start date: November 2005
• Est. completion date: September 2009

Study information

• Verified date: September 2009
• Source: PETHEMA Foundation
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ministry of Health
• Study type: Interventional

Clinical Trial 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

Description:

Clinical trial with a drug in new conditions of use

Recruitment information / eligibility

• Status: Completed
• Enrollment: 132
• Est. completion date: September 2009
• Est. primary completion date: September 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 2 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cytomegalovirus Infection
• Cytomegalovirus Infections

Intervention

Drug:
• Valganciclovir
900 mg/ 12 h oral, 2 weeks 900 mg/ 24 h oral, 2 weeks

Locations

Country	Name	City	State
Spain	Hospital Clínico y Provincial de Barcelona	Barcelona
Spain	Hospital Universitario "Germans Trias i Pujol"	Barcelona
Spain	Hospital general de Jerez de la Frontera	Jerez de la Frontera
Spain	Hospital Universitario de la Princesa	Madrid
Spain	Hospital Universitario La Paz	Madrid
Spain	Hospital Universitario Ramón y Cajal, Madrid	Madrid
Spain	Hospital Universitario Morales Meseguer, Murcia	Murcia
Spain	Hospital Clínico Universitario de Salamanca	Salamanca

Sponsors (1)

Lead Sponsor	Collaborator
PETHEMA Foundation

Country where clinical trial is conducted

Spain, 

References & Publications (12)

Burri M, Wiltshire H, Kahlert C, Wouters G, Rudin C. Oral valganciclovir in children: single dose pharmacokinetics in a six-year-old girl. Pediatr Infect Dis J. 2004 Mar;23(3):263-6. — View Citation

Ciancio G, Burke GW, Mattiazzi A, Leibovici Z, Dowdy L, Roth D, Kupin W, Rosen A, Jorge D, Cirocco RE, Miller J. Cytomegalovirus prophylaxis with valganciclovir in kidney, pancreas-kidney, and pancreas transplantation. Clin Transplant. 2004 Aug;18(4):402-6. — View Citation

Clark BS, Chang IF, Karpen SJ, Herrera L, Scott JD, Bristow LJ, Quirós-Tejeira RE, Goss JA. Valganciclovir for the prophylaxis of cytomegalovirus disease in pediatric liver transplant recipients. Transplantation. 2004 May 15;77(9):1480. — View Citation

Cvetkovic RS, Wellington K. Valganciclovir: a review of its use in the management of CMV infection and disease in immunocompromised patients. Drugs. 2005;65(6):859-78. Review. — View Citation

Einsele H, Reusser P, Hertenstein B, Bornhäuser M, Kröger N, Kahls P, et al. Pharmakokinetics of Valganciclovir after AlloSCT: A Fixed Oral Dose Can Be Used for Preemptive Therapy in Patients with Normal Body Weight - Even with Intestinal GVHD. Blood 2004;104(11):abstract 2239.

Ljungman P, de La Camara R, Milpied N, Volin L, Russell CA, Crisp A, Webster A; Valacyclovir International Bone Marrow Transplant Study Group. Randomized study of valacyclovir as prophylaxis against cytomegalovirus reactivation in recipients of allogeneic bone marrow transplants. Blood. 2002 Apr 15;99(8):3050-6. — View Citation

Ljungman P, Griffiths P, Paya C. Definitions of cytomegalovirus infection and disease in transplant recipients. Clin Infect Dis. 2002 Apr 15;34(8):1094-7. Epub 2002 Mar 11. Review. — View Citation

Ljungman P, Reusser P, de la Camara R, Einsele H, Engelhard D, Ribaud P, Ward K; European Group for Blood and Marrow Transplantation. Management of CMV infections: recommendations from the infectious diseases working party of the EBMT. Bone Marrow Transplant. 2004 Jun;33(11):1075-81. — View Citation

Nichols WG, Corey L, Gooley T, Drew WL, Miner R, Huang M, Davis C, Boeckh M. Rising pp65 antigenemia during preemptive anticytomegalovirus therapy after allogeneic hematopoietic stem cell transplantation: risk factors, correlation with DNA load, and outcomes. Blood. 2001 Feb 15;97(4):867-74. — View Citation

Paya C, Humar A, Dominguez E, Washburn K, Blumberg E, Alexander B, Freeman R, Heaton N, Pescovitz MD; Valganciclovir Solid Organ Transplant Study Group. Efficacy and safety of valganciclovir vs. oral ganciclovir for prevention of cytomegalovirus disease in solid organ transplant recipients. Am J Transplant. 2004 Apr;4(4):611-20. — View Citation

Razonable RR, Paya CV. Valganciclovir for the prevention and treatment of cytomegalovirus disease in immunocompromised hosts. Expert Rev Anti Infect Ther. 2004 Feb;2(1):27-41. Review. — View Citation

Reusser P, Einsele H, Lee J, Volin L, Rovira M, Engelhard D, Finke J, Cordonnier C, Link H, Ljungman P; Infectious Diseases Working Party of the European Group for Blood and Marrow Transplantation. Randomized multicenter trial of foscarnet versus ganciclovir for preemptive therapy of cytomegalovirus infection after allogeneic stem cell transplantation. Blood. 2002 Feb 15;99(4):1159-64. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To value valganciclovir efficacy in advance treatment of CMV in patients received allogenic transplant with a uniform treatment.		1 year	No
Secondary	To value valganciclovir security in advance treatment of CMV in in patients received allogenic transplant with a uniform treatment.		1 year	Yes

External Links

•   Pethema Foundation web
•   Spanish association of Haematology