Trial Outcomes & Findings for Pre-engraftment Cytomegalovirus DNAemia (NCT NCT03889028)

NCT ID: NCT03889028

Last Updated: 2020-12-11

Results Overview

absolute neutrophil count ≥500/mm3 on 3 consecutive days,, the first of which being time of engraftment.

Recruitment status

COMPLETED

Target enrollment

878 participants

Primary outcome timeframe

30 days

Results posted on

2020-12-11

Participant Flow

Adult patients undergoing T-cell replete allo-HSCT at 20 different centers in Spain from September 2014 to December 2015 (Registry of the Working group on Infectious and Non-Infectious Complications of the GETH-Spanish Hematopoietic Transplantation and Cell Therapy Group-). A total of 218 adult patients who received an unmanipulated allo-HSCT at the Clinical University Hospital of Valencia from March 2010 to May 2019 (excluding patients recruited in the GETH registry) were also included

Unit of analysis: Patients with or without CMV DNAemia

Participant milestones

Participant milestones
Measure	Pre-CMV DNAemia Patients who developed CMV DNAemia prior to engraftment	Post-CMV DNAemia Patients with CMV DNAemia detected after neutrophil's engraftment	No CMV DNAemia Patients without CMV DNAemia throughout the study period
Overall Study STARTED	144 144	422 422	312 312
Overall Study COMPLETED	144 144	422 422	312 312
Overall Study NOT COMPLETED	0 0	0 0	0 0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Pre-engraftment Cytomegalovirus DNAemia

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Pre-CMV DNAemia n=144 Participants Patients with CMV DNAemia detected prior neutrophil's engraftment	Post-CMV DNAemia n=422 Participants Patients with CMV DNAemia detected after neutrophil's engraftment	No CMV n=312 Participants Patients without CMV DNAemia	Total n=878 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	134 Participants n=5 Participants	370 Participants n=7 Participants	275 Participants n=5 Participants	779 Participants n=4 Participants
Age, Categorical >=65 years	10 Participants n=5 Participants	52 Participants n=7 Participants	37 Participants n=5 Participants	99 Participants n=4 Participants
Sex: Female, Male Female	57 Participants n=5 Participants	174 Participants n=7 Participants	135 Participants n=5 Participants	366 Participants n=4 Participants
Sex: Female, Male Male	87 Participants n=5 Participants	248 Participants n=7 Participants	177 Participants n=5 Participants	512 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) White	144 Participants n=5 Participants	422 Participants n=7 Participants	312 Participants n=5 Participants	878 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants

PRIMARY outcome

Timeframe: 30 days

Population: Patients with CMV DNAemia

absolute neutrophil count ≥500/mm3 on 3 consecutive days,, the first of which being time of engraftment.

Outcome measures

Outcome measures
Measure	Pre-CMV DNAemia n=144 Participants episodes of CMV DNAemia that were detected prior to engraftment	Post-CMV DNAemia n=422 Participants episodes of CMV DNAemia that were detected after engraftment
Time to Engraftment (Days) Stratified by CMV DNaemia Occurring Before or After Neutrophil's Engraftment	17 days Interval 8.0 to 42.0	19 days Interval 5.0 to 57.0

SECONDARY outcome

Timeframe: 1 year

Population: Patients with CMV DNAemia detected prior or after neutrophil's engraftment

total number of deaths from any cause

Outcome measures

Outcome measures
Measure	Pre-CMV DNAemia n=144 Participants episodes of CMV DNAemia that were detected prior to engraftment	Post-CMV DNAemia n=422 Participants episodes of CMV DNAemia that were detected after engraftment
Overall Mortality	54 Participants	131 Participants

SECONDARY outcome

Timeframe: 1 year

total number of deaths without relapse or underlying disease progression

Outcome measures

Outcome measures
Measure	Pre-CMV DNAemia n=144 Participants episodes of CMV DNAemia that were detected prior to engraftment	Post-CMV DNAemia n=422 Participants episodes of CMV DNAemia that were detected after engraftment
Non-relapse Mortality	34 Participants	96 Participants

Adverse Events

Pre-CMV DNAemia

Serious events: 0 serious events

Other events: 0 other events

Deaths: 54 deaths

Post-CMV DNAemia

Serious events: 0 serious events

Other events: 0 other events

Deaths: 131 deaths

No CMV DNAemia

Serious events: 0 serious events

Other events: 0 other events

Deaths: 94 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

David Navarro

Clinical University Hospital of Valencia

Phone: +34961973500

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place