Cytomegalovirus Infection After HSCT and PT-CY as GVHD Pr... | NCT05315882

Studies
Cytomegalovirus Infection After HSCT and PT-CY as GVHD Prophylaxis >> GVHD PROPHYLAXIS ERA

NCT05315882

Sponsor

Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud

Status

Completed

Last Update Posted

Apr 7, 2022Actual

Enrollment

300Actual

Phase

Not provided

Conditions

CMV Infection

Interventions

Not provided

Countries

Spain

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 14, 2020Actual

Primary Completion Date

Mar 17, 2020Actual

Completion Date

Dec 17, 2020Actual

First Submitted Date

Mar 8, 2022

First Submission Date that Met QC Criteria

Mar 30, 2022

First Posted Date

Apr 7, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 30, 2022

Last Update Posted Date

Apr 7, 2022Actual

Name	Class
Merck Sharp & Dohme LLC	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Multicentre, observational, retrospective study to analyze the differences in CMVi pattern and recurrences between two groups of allogeneic HSCT patients (haplo vs no haplo HSCT), with intervention both postransplant cyclophosphamide as GvHD prophylaxis, using a database with information from historical clinic data.

Detailed Description

The overall aim of the study is to to analize CMVi after PTCy for GVHD prophylaxis, with a detailed description of CMVi and recurrences, direct and indirect consequences, in a HSCT population comparing two cohorts: haploidentical HSCT vs no haploidentical HSCT

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

300Actual

Label	Type	Description	Intervention Names
Allogeneic stem cell transplantation		Observational, no interventional

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Incidence of CMVi in HSCT with PT-Cy and CMVi requiring pre-emptive therapy (significant CMVi)		1 year
Median time to CMVi		1 year
Cumulative incidence of PET-CMVi by day +100, +180 and +365.		1 year
Overall survival by day +100, +180 and +365		1 year
Overall mortality by day +100, +180 and +365		1 year
Non-relapse mortality by day +100, +180 and +365		1 year

Secondary Outcomes

Measure	Description	Time Frame
CMV indirect effects incidence	Hospital admissions, secondary infections, secondary toxicity.	1 year
Incidence of CMVi recurrent episodes		1 year

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age > 18 years.
Period of HSCT: January 1st 2013 to December 31th 2018.
GvHD prophylaxis: Post-transplantation Cyclophosphamide (50 mg/Kg on days +3 and +4 or +3 and +5) and calcineurine inhibitors as GvHD prophylaxis.
Conditioning chemotherapy regimen and source of stem cells: myeloablative or reduced intensity TBF (Thiotepa 5 mg/Kg D -7-6, Fludarabine 50 mg/m2 D -5-4-3, Busulfan 3,2 mg/Kg D -4-3-2) starting on D-7 followed by peripheral blood or bone marrow infusion on day 0.

Exclusion Criteria:

Cord blood HSCT.
Antilymphocytic or anti thymocytic thymoglobulin as GvHD prophylaxis.
Alentuzumab as GvHD prophylaxis.

3. Sirolimus as GvHD prophylaxis.

4. HIV positive, HVC, HVB active or latent at HSCT.

5. CMV prophylaxis with letermovir.

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

300 patients with hematological malignancies under HSCT from matched sibling donors, unrelated matched and mistmatched donor and haploidentical family donor using PT-CY and CNI as GVHD prophylaxis

Sampling Method

Non-Probability Sample

Name	Affiliation	Role
MARIA JESUS PASCUAL, MD	HOSPITAL REGIONAL MALAGA / BMT UNIT	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Maria Jesus Pascual		Málaga		29010	Spain

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

Communication at the EBMT 2022 Prague congress

Types

Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)

Time Frame

19 March 2022

Access Criteria

Not provided

URL

https://www.ebmt.org/annual-meeting

Type	Date	Date Unknown
Release	Jul 28, 2022
Reset	Jun 29, 2023

ID	Term
D006566	Herpesviridae Infections
D004266	DNA Virus Infections
D014777	Virus Diseases
D007239	Infections