Registry on Salvage Antiviral Treatment for Patients Experiencing ADV and / or CMV Reactivation Post Allogeneic HSCT

Infectious Complications Following HSCT Clinical Trial

— EPROS  

Official title:

European Patient Registry on Salvage Antiviral Treatment for Patients Experiencing Adenovirus and / or Cytomegalovirus Reactivation Post Allogeneic Hematopoietic Stem Cell Transplantation

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02873325
• Other study ID #: CM-2016-01
• Status: Terminated
• Phase: N/A
• First received: October 21, 2015
• Last updated: January 30, 2018
• Start date: May 11, 2016
• Est. completion date: February 23, 2017

Study information

• Verified date: January 2018
• Source: Cell Medica Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

DESIGN:

Disease registry - non-interventional.

INDICATION: Patients failing first or subsequent line treatment for adenovirus and / or cytomegalovirus reactivation post allogeneic hematopoietic stem cell transplantation.

Description:

In this disease registry, data on approximately 120 allo HSCT patients who have received salvage treatment (second or later line) with any antiviral therapy for ADV and / or CMV post allogeneic HSCT will be documented; of these 120, at least 40 patients will have been treated with Cell Medica's immune reconstitution ACT as salvage therapy. The patients will be consented prospectively or retrospectively for collection of data. Data will be collected at baseline, 6 months and 1 year after commencement of salvage treatment. Retrospective data collection (for patients who underwent HSCT in 2010 or later) is permitted.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: February 23, 2017
• Est. primary completion date: February 23, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

1. Written informed consent

2. Physician requested salvage (defined as refractory to first, requirement for second line or greater) treatment for ADV and / or CMV reactivation post allogeneic HSCT.

Related Conditions & MeSH terms

• Infectious Complications Following HSCT

Intervention

Other:
• antiviral therapies for CMV and/or ADV
salvage antiviral treatments for ADV and/or CMV

Locations

Country	Name	City	State
United Kingdom	Birmigham Children Hospital	Birmingham
United Kingdom	Bristol Royal Hospital For Children	Bristol

Sponsors (1)

Lead Sponsor	Collaborator
Cell Medica Ltd

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ADV and/or CMV reactivations	assessment of ADV/CMV viral clearance to evaluate the efficacy of salvage therapies for ADV and / or CMV infections post allogeneic HSCT	12 months