N/A
N=484
Nutrition and Outcomes of Hematopoietic Cell Transplantation (HCT)
Allogeneic Stem Cell Transplant · Graft Versus Host Disease · Hematologic Malignancy · Stem Cell Transplant Complications
Bottom Line
View on ClinicalTrials.gov: NCT03419078 ↗Enrolled (actual)
484
Serious AEs
0.0%
Results posted
Oct 2019
Primary outcome: Primary: Number of Participants With Acute Graft Versus Host Disease (GvHD) at Any Site (Grade II or Above) and Acute GvHD of the Gut of Any Grade — 75; 73; 31; 63 Participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Pediatric, Adult, Older Adult · 17+ yrs
- Sex
- All
- Sponsor
- Imperial College Healthcare NHS Trust
- Primary completion
- Jun 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Acute Graft Versus Host Disease (GvHD) at Any Site (Grade II or Above) and Acute GvHD of the Gut of Any Grade |
75; 73; 31; 63; 63; 27 | — |
| PRIMARY Non Relapse Mortality |
8.2; 17.6; 27.5 | — |
| SECONDARY Graft Versus Host Disease-free and Relapse-free Survival |
39.183; 29.729; 27.472 | — |
| SECONDARY 5 Year Survival |
53.877; 45.946; 41.758 | — |
Summary
Retrospective case-note review to determine if nutrition via the enteral compared to the parenteral route results in better outcomes after haematopoietic cell transplantation.
Eligibility Criteria
Inclusion Criteria
- Patients undergoing their first HCT for a hematologic malignancy
- Undergoing HCT using a sibling or unrelated donor
- Undergoing HCT infusion between January 2000 and December 2014
Exclusion Criteria
- HCT using umbilical cord blood donors
- HCT using haploidentical donors
Data sourced from ClinicalTrials.gov (NCT03419078). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.