An observational study in Allogeneic Stem Cell Transplant, Graft Versus Host Disease and Hematologic Malignancy, sponsored by Imperial College Healthcare NHS Trust. Completed. Open to participants aged 17 Years and older. Per ClinicalTrials.gov, last updated 2019-10-21.
Sponsored by Imperial College Healthcare NHS Trust · Observational
Retrospective case-note review to determine if nutrition via the enteral compared to the parenteral route results in better outcomes after haematopoietic cell transplantation.
This is a retrospective case-note review of adults undergoing haematopoietic cell transplantation to treat a haematological malignancy who have been admitted to Hammersmith Hospital from 2000 to 2014. All patients receiving an allogeneic haematopoietic cell transplant from a matched sibling or identically matched unrelated donor will be included. We will record the route and assess the broad adequacy of nutritional intakes to determine if nutrition via the enteral compared to the parenteral route results in better outcomes after haematopoietic cell transplantation. Our outcomes are graft versus host disease incidence and severity, transplant related (early) mortality and overall survival.
All patients aged 17 or above who underwent their first HCT for hematologic malignancy at Hammersmith Hospital, using a sibling or unrelated donor between January 2000 and December 2014
Exclusion Criteria:
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
Occurrence of acute GvHD at any site (grade II or above) and acute GvHD of the gut of any grade (graded according to standard criteria). Standard criteria to grade the severity of acute GvHD are quantification of rash, serum bilirubin and diarrhoea. These standard criteria have been developed and used for \> 20 years by most transplant centres to improve comparability between publications.
Time frame: 100 days after the date of hematopoietic cell infusion
Non Relapse Mortality
Defined as death without previous relapse
Time frame: 100 days after the date of hematopoietic cell infusion
Graft Versus Host Disease-free and Relapse-free Survival
GvHD-free/relapse-free survival (GRFS). Events in GRFS included grade 3-4 acute GvHD, systemic therapy-requiring chronic GvHD, relapse, or death
Time frame: 5 years after the date of hematopoietic cell infusion
5 Year Survival
Time frame: 5 years after the date of hematopoietic cell infusion
| Milestone | Adequate Enteral Nutrition | Adequate Parenteral Nutrition | Inadequate Nutrition |
|---|---|---|---|
| Started | 245 | 148 | 91 |
| Completed | 245 | 148 | 91 |
| Not completed | 0 | 0 | 0 |
Occurrence of acute GvHD at any site (grade II or above) and acute GvHD of the gut of any grade (graded according to standard criteria). Standard criteria to grade the severity of acute GvHD are quantification of rash, serum bilirubin and diarrhoea. These standard criteria have been developed and used for \> 20 years by most transplant centres to improve comparability between publications.
| Participants | Adequate Enteral Nutrition | Adequate Parenteral Nutrition | Inadequate Nutrition |
|---|---|---|---|
| Acute GvHD grade II-IV | 75 | 73 | 31 |
| Gut Acute GvHD any grade | 63 | 63 | 27 |
Defined as death without previous relapse
| percentage of participants | Adequate Enteral Nutrition | Adequate Parenteral Nutrition | Inadequate Nutrition |
|---|---|---|---|
| Non Relapse Mortality | 8.2 (5 to 12) | 17.6 (12 to 25) | 27.5 (20 to 38) |
GvHD-free/relapse-free survival (GRFS). Events in GRFS included grade 3-4 acute GvHD, systemic therapy-requiring chronic GvHD, relapse, or death
| percentage of participants | Adequate Enteral Nutrition | Adequate Parenteral Nutrition | Inadequate Nutrition |
|---|---|---|---|
| Graft Versus Host Disease-free and Relapse-free Survival | 39.183 (33 to 46) | 29.729 (22 to 39) | 27.472 (17 to 39) |
| percentage of participants | Adequate Enteral Nutrition | Adequate Parenteral Nutrition | Inadequate Nutrition |
|---|---|---|---|
| 5 Year Survival | 53.877 (48 to 61) | 45.946 (38 to 55) | 41.758 (32 to 53) |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Adequate Enteral Nutrition | — | 0/245 (0%) | 0/245 (0%) |
| Adequate Parenteral Nutrition | — | 0/148 (0%) | 0/148 (0%) |
| Inadequate Nutrition | — | 0/91 (0%) | 0/91 (0%) |
| Age, Customized(Participants) | Adequate Enteral Nutrition | Adequate Parenteral Nutrition | Inadequate Nutrition | Total |
|---|---|---|---|---|
| Age — <20 years | 3 | 5 | 2 | 10 |
| Age — 21-40 | 87 | 84 | 41 | 212 |
| Age — 41-60 | 134 | 53 | 40 | 227 |
| Age — >60 years | 21 | 6 | 8 | 35 |
| Sex: Female, Male(Participants) | Adequate Enteral Nutrition | Adequate Parenteral Nutrition | Inadequate Nutrition | Total |
|---|---|---|---|---|
| Female | 96 | 47 | 36 | 179 |
| Male | 149 | 101 | 55 | 305 |
| Diagnosis(Participants) | Adequate Enteral Nutrition | Adequate Parenteral Nutrition | Inadequate Nutrition | Total |
|---|---|---|---|---|
| Acute leukaemia | 73 | 57 | 28 | 158 |
| CML | 81 | 70 | 35 | 186 |
| Lymphoma & CLL MDS | 56 | 12 | 15 | 83 |
| MDS | 27 | 4 | 6 | 37 |
| Myeloma | 8 | 5 | 7 | 20 |
| European Group for Blood and Marrow Transplantation (EBMT)disease risk(Participants) | Adequate Enteral Nutrition | Adequate Parenteral Nutrition | Inadequate Nutrition | Total |
|---|---|---|---|---|
| Early staged | 110 | 75 | 44 | 229 |
| Intermediate staged | 70 | 47 | 22 | 139 |
| Late staged | 65 | 26 | 25 | 116 |
| BMI (kg/m^2)(Participants) | Adequate Enteral Nutrition | Adequate Parenteral Nutrition | Inadequate Nutrition | Total |
|---|---|---|---|---|
| Underweight (less than 20) | 15 | 14 | 7 | 36 |
| Healthy (20 - 24.9) | 90 | 63 | 28 | 181 |
| Overweight (25 - 30) | 121 | 50 | 45 | 216 |
| Obese (over 30) | 19 | 21 | 11 | 51 |
| Donor match(Participants) | Adequate Enteral Nutrition | Adequate Parenteral Nutrition | Inadequate Nutrition | Total |
|---|---|---|---|---|
| Matched sibling | 136 | 56 | 56 | 248 |
| Matched unrelated | 86 | 71 | 25 | 182 |
| Mismatch unrelated | 23 | 21 | 10 | 54 |
| Conditioning(Participants) | Adequate Enteral Nutrition | Adequate Parenteral Nutrition | Inadequate Nutrition | Total |
|---|---|---|---|---|
| Myeloablative | 98 | 131 | 56 | 285 |
| Reduced intensity | 147 | 17 | 35 | 199 |
| Previous autograft(Participants) | Adequate Enteral Nutrition | Adequate Parenteral Nutrition | Inadequate Nutrition | Total |
|---|---|---|---|---|
| yes | 26 | 9 | 12 | 47 |
| no | 219 | 139 | 79 | 437 |
7 further baseline measures are reported on the registry.
No study locations are listed for this record.
Plan to share: No
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Imperial College Healthcare NHS Trust