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TAMOVALCIR in Allogenic Hematopoietic Progenitors Transplant

Primary Purpose

Cytomegalovirus Infection

Status
Completed
Phase
Phase 2
Locations
Spain
Study Type
Interventional
Intervention
Valganciclovir
Sponsored by
PETHEMA Foundation
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cytomegalovirus Infection focused on measuring Cytomegalovirus infection

Eligibility Criteria

2 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
October 9, 2006
Last Updated
September 17, 2009
Sponsor
PETHEMA Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT00386412
Brief Title
TAMOVALCIR in Allogenic Hematopoietic Progenitors Transplant
Official Title
Phase II, Multicentric, Prospective and Opened Clinical Trial of Advance Valganciclovir Treatment of CMV in Allogenic Hematopoietic Progenitors Transplant
Study Type
Interventional

2. Study Status

Record Verification Date
September 2009
Overall Recruitment Status
Completed
Study Start Date
November 2005 (undefined)
Primary Completion Date
September 2009 (Actual)
Study Completion Date
September 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
PETHEMA Foundation

4. Oversight

5. Study Description

Brief 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
Detailed Description
Clinical trial with a drug in new conditions of use

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cytomegalovirus Infection
Keywords
Cytomegalovirus infection

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
132 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Valganciclovir
Intervention Description
900 mg/ 12 h oral, 2 weeks 900 mg/ 24 h oral, 2 weeks
Primary Outcome Measure Information:
Title
To value valganciclovir efficacy in advance treatment of CMV in patients received allogenic transplant with a uniform treatment.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
To value valganciclovir security in advance treatment of CMV in in patients received allogenic transplant with a uniform treatment.
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
de la Cámara Rafael, Dr
Organizational Affiliation
Hospital Universitario La Princesa
Official's Role
Study Chair
Facility Information:
Facility Name
Hospital Clínico y Provincial de Barcelona
City
Barcelona
Country
Spain
Facility Name
Hospital Universitario "Germans Trias i Pujol"
City
Barcelona
Country
Spain
Facility Name
Hospital general de Jerez de la Frontera
City
Jerez de la Frontera
Country
Spain
Facility Name
Hospital Universitario de la Princesa
City
Madrid
Country
Spain
Facility Name
Hospital Universitario La Paz
City
Madrid
Country
Spain
Facility Name
Hospital Universitario Ramón y Cajal, Madrid
City
Madrid
Country
Spain
Facility Name
Hospital Universitario Morales Meseguer, Murcia
City
Murcia
Country
Spain
Facility Name
Hospital Clínico Universitario de Salamanca
City
Salamanca
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
15077131
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. doi: 10.1038/sj.bmt.1704505. No abstract available.
Results Reference
background
PubMed Identifier
11929799
Citation
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. doi: 10.1182/blood.v99.8.3050.
Results Reference
background
PubMed Identifier
11830461
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. doi: 10.1182/blood.v99.4.1159.
Results Reference
background
PubMed Identifier
15482169
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. doi: 10.1586/14787210.2.1.27.
Results Reference
background
PubMed Identifier
15819597
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. doi: 10.2165/00003495-200565060-00012.
Results Reference
background
PubMed Identifier
15023154
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. doi: 10.1111/j.1600-6143.2004.00382.x.
Results Reference
background
PubMed Identifier
15167619
Citation
Clark BS, Chang IF, Karpen SJ, Herrera L, Scott JD, Bristow LJ, Quiros-Tejeira RE, Goss JA. Valganciclovir for the prophylaxis of cytomegalovirus disease in pediatric liver transplant recipients. Transplantation. 2004 May 15;77(9):1480. doi: 10.1097/01.tp.0000123081.81022.33. No abstract available.
Results Reference
background
PubMed Identifier
15233817
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. doi: 10.1111/j.1399-0012.2004.00180.x.
Results Reference
background
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.
Results Reference
background
PubMed Identifier
11914998
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. doi: 10.1086/339329. Epub 2002 Mar 11.
Results Reference
background
PubMed Identifier
15014306
Citation
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. doi: 10.1097/01.inf.0000116760.16582.a9.
Results Reference
background
PubMed Identifier
11159510
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. doi: 10.1182/blood.v97.4.867.
Results Reference
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Links:
URL
http://www.aehh.org
Description
Spanish association of Haematology

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TAMOVALCIR in Allogenic Hematopoietic Progenitors Transplant

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