Trial Outcomes & Findings for Nutrition and Outcomes of Hematopoietic Cell Transplantation (HCT) (NCT NCT03419078)
NCT ID: NCT03419078
Last Updated: 2019-10-21
Results Overview
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.
Recruitment status
COMPLETED
Target enrollment
484 participants
Primary outcome timeframe
100 days after the date of hematopoietic cell infusion
Results posted on
2019-10-21
Participant Flow
Participant milestones
| Measure |
Adequate Enteral Nutrition
Adequate nutrition in the period to engraftment after transplant, in those patients nourished orally or any patient that required 4 or more days of enteral tube feeding.
|
Adequate Parenteral Nutrition
Patients that were adequately nourished during the period to engraftment after transplant, that received 4 or more days of parenteral nutrition.
|
Inadequate Nutrition
Those with inadequate oral in take and a documented unmet need for artificial nutrition support for 4 or more days before engraftment.
|
|---|---|---|---|
|
Overall Study
STARTED
|
245
|
148
|
91
|
|
Overall Study
COMPLETED
|
245
|
148
|
91
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Nutrition and Outcomes of Hematopoietic Cell Transplantation (HCT)
Baseline characteristics by cohort
| Measure |
Adequate Enteral Nutrition
n=245 Participants
Adequate nutrition in the period to engraftment after transplant, in those patients nourished orally or any patient that required 4 or more days of enteral tube feeding.
|
Adequate Parenteral Nutrition
n=148 Participants
Patients that were adequately nourished during the period to engraftment after transplant, that received 4 or more days of parenteral nutrition.
|
Inadequate Nutrition
n=91 Participants
Those with inadequate oral in take and a documented unmet need for artificial nutrition support for 4 or more days before engraftment.
|
Total
n=484 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Customized
Age · <20 years
|
3 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
10 Participants
n=7 Participants
|
|
Age, Customized
Age · 21-40
|
87 Participants
n=99 Participants
|
84 Participants
n=107 Participants
|
41 Participants
n=206 Participants
|
212 Participants
n=7 Participants
|
|
Age, Customized
Age · 41-60
|
134 Participants
n=99 Participants
|
53 Participants
n=107 Participants
|
40 Participants
n=206 Participants
|
227 Participants
n=7 Participants
|
|
Age, Customized
Age · >60 years
|
21 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
35 Participants
n=7 Participants
|
|
Sex: Female, Male
Female
|
96 Participants
n=99 Participants
|
47 Participants
n=107 Participants
|
36 Participants
n=206 Participants
|
179 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
149 Participants
n=99 Participants
|
101 Participants
n=107 Participants
|
55 Participants
n=206 Participants
|
305 Participants
n=7 Participants
|
|
Diagnosis
Acute leukaemia
|
73 Participants
n=99 Participants
|
57 Participants
n=107 Participants
|
28 Participants
n=206 Participants
|
158 Participants
n=7 Participants
|
|
Diagnosis
CML
|
81 Participants
n=99 Participants
|
70 Participants
n=107 Participants
|
35 Participants
n=206 Participants
|
186 Participants
n=7 Participants
|
|
Diagnosis
Lymphoma & CLL MDS
|
56 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
15 Participants
n=206 Participants
|
83 Participants
n=7 Participants
|
|
Diagnosis
MDS
|
27 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
37 Participants
n=7 Participants
|
|
Diagnosis
Myeloma
|
8 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
20 Participants
n=7 Participants
|
|
European Group for Blood and Marrow Transplantation (EBMT)disease risk
Early staged
|
110 Participants
n=99 Participants
|
75 Participants
n=107 Participants
|
44 Participants
n=206 Participants
|
229 Participants
n=7 Participants
|
|
European Group for Blood and Marrow Transplantation (EBMT)disease risk
Intermediate staged
|
70 Participants
n=99 Participants
|
47 Participants
n=107 Participants
|
22 Participants
n=206 Participants
|
139 Participants
n=7 Participants
|
|
European Group for Blood and Marrow Transplantation (EBMT)disease risk
Late staged
|
65 Participants
n=99 Participants
|
26 Participants
n=107 Participants
|
25 Participants
n=206 Participants
|
116 Participants
n=7 Participants
|
|
BMI (kg/m^2)
Underweight (less than 20)
|
15 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
36 Participants
n=7 Participants
|
|
BMI (kg/m^2)
Healthy (20 - 24.9)
|
90 Participants
n=99 Participants
|
63 Participants
n=107 Participants
|
28 Participants
n=206 Participants
|
181 Participants
n=7 Participants
|
|
BMI (kg/m^2)
Overweight (25 - 30)
|
121 Participants
n=99 Participants
|
50 Participants
n=107 Participants
|
45 Participants
n=206 Participants
|
216 Participants
n=7 Participants
|
|
BMI (kg/m^2)
Obese (over 30)
|
19 Participants
n=99 Participants
|
21 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
51 Participants
n=7 Participants
|
|
Donor match
Matched sibling
|
136 Participants
n=99 Participants
|
56 Participants
n=107 Participants
|
56 Participants
n=206 Participants
|
248 Participants
n=7 Participants
|
|
Donor match
Matched unrelated
|
86 Participants
n=99 Participants
|
71 Participants
n=107 Participants
|
25 Participants
n=206 Participants
|
182 Participants
n=7 Participants
|
|
Donor match
Mismatch unrelated
|
23 Participants
n=99 Participants
|
21 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
54 Participants
n=7 Participants
|
|
Conditioning
Myeloablative
|
98 Participants
n=99 Participants
|
131 Participants
n=107 Participants
|
56 Participants
n=206 Participants
|
285 Participants
n=7 Participants
|
|
Conditioning
Reduced intensity
|
147 Participants
n=99 Participants
|
17 Participants
n=107 Participants
|
35 Participants
n=206 Participants
|
199 Participants
n=7 Participants
|
|
Previous autograft
yes
|
26 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
47 Participants
n=7 Participants
|
|
Previous autograft
no
|
219 Participants
n=99 Participants
|
139 Participants
n=107 Participants
|
79 Participants
n=206 Participants
|
437 Participants
n=7 Participants
|
|
Patient / Donor Sex
Other combination
|
188 Participants
n=99 Participants
|
124 Participants
n=107 Participants
|
72 Participants
n=206 Participants
|
384 Participants
n=7 Participants
|
|
Patient / Donor Sex
Male / Female
|
56 Participants
n=99 Participants
|
24 Participants
n=107 Participants
|
19 Participants
n=206 Participants
|
99 Participants
n=7 Participants
|
|
Patient / Donor Sex
Missing data
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
|
Patient cytomegalovirus (CMV) serology
Positive
|
100 Participants
n=99 Participants
|
71 Participants
n=107 Participants
|
31 Participants
n=206 Participants
|
202 Participants
n=7 Participants
|
|
Patient cytomegalovirus (CMV) serology
Negative
|
142 Participants
n=99 Participants
|
77 Participants
n=107 Participants
|
58 Participants
n=206 Participants
|
277 Participants
n=7 Participants
|
|
Patient cytomegalovirus (CMV) serology
Missing data
|
3 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
5 Participants
n=7 Participants
|
|
Donor CMV serology
Positive
|
109 Participants
n=99 Participants
|
82 Participants
n=107 Participants
|
47 Participants
n=206 Participants
|
238 Participants
n=7 Participants
|
|
Donor CMV serology
Negative
|
131 Participants
n=99 Participants
|
64 Participants
n=107 Participants
|
43 Participants
n=206 Participants
|
238 Participants
n=7 Participants
|
|
Donor CMV serology
Missing data
|
5 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
8 Participants
n=7 Participants
|
|
Cells infused
PBSC
|
184 Participants
n=99 Participants
|
88 Participants
n=107 Participants
|
54 Participants
n=206 Participants
|
326 Participants
n=7 Participants
|
|
Cells infused
Bone marrow (BM)
|
59 Participants
n=99 Participants
|
59 Participants
n=107 Participants
|
37 Participants
n=206 Participants
|
155 Participants
n=7 Participants
|
|
Cells infused
PBSC + BM
|
3 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
6 Participants
n=7 Participants
|
|
Cluster of differentiation 34 (CD34+) cells infused
Less than 4.00 x 10^6
|
40 Participants
n=99 Participants
|
46 Participants
n=107 Participants
|
29 Participants
n=206 Participants
|
115 Participants
n=7 Participants
|
|
Cluster of differentiation 34 (CD34+) cells infused
More than 3.99 x 10^6
|
173 Participants
n=99 Participants
|
87 Participants
n=107 Participants
|
53 Participants
n=206 Participants
|
313 Participants
n=7 Participants
|
|
Cluster of differentiation 34 (CD34+) cells infused
Missing data
|
32 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
56 Participants
n=7 Participants
|
|
Era (years)
2000 - 2004
|
82 Participants
n=99 Participants
|
70 Participants
n=107 Participants
|
47 Participants
n=206 Participants
|
199 Participants
n=7 Participants
|
|
Era (years)
2005 - 2009
|
78 Participants
n=99 Participants
|
42 Participants
n=107 Participants
|
18 Participants
n=206 Participants
|
138 Participants
n=7 Participants
|
|
Era (years)
2010 - 2014
|
85 Participants
n=99 Participants
|
36 Participants
n=107 Participants
|
26 Participants
n=206 Participants
|
147 Participants
n=7 Participants
|
|
Hematopoietic cell transplant co-morbidity index (HCT-CI)
0-1
|
130 Participants
n=99 Participants
|
70 Participants
n=107 Participants
|
50 Participants
n=206 Participants
|
250 Participants
n=7 Participants
|
|
Hematopoietic cell transplant co-morbidity index (HCT-CI)
2-3
|
75 Participants
n=99 Participants
|
55 Participants
n=107 Participants
|
18 Participants
n=206 Participants
|
148 Participants
n=7 Participants
|
|
Hematopoietic cell transplant co-morbidity index (HCT-CI)
more than 3
|
22 Participants
n=99 Participants
|
16 Participants
n=107 Participants
|
18 Participants
n=206 Participants
|
56 Participants
n=7 Participants
|
|
Hematopoietic cell transplant co-morbidity index (HCT-CI)
missing data
|
18 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
30 Participants
n=7 Participants
|
PRIMARY outcome
Timeframe: 100 days after the date of hematopoietic cell infusionPopulation: There were 439 and 438 evaluable cases respectively for acute GvHD grade II or greater and gastrointestinal acute GvHD of any grade after exclusion of patients that died before day 100 without acute GvHD.
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.
Outcome measures
| Measure |
Adequate Enteral Nutrition
n=232 Participants
Adequate nutrition in the period to engraftment after transplant, in those patients nourished orally or any patient that required 4 or more days of enteral tube feeding.
|
Adequate Parenteral Nutrition
n=132 Participants
Patients that were adequately nourished during the period to engraftment after transplant, that received 4 or more days of parenteral nutrition.
|
Inadequate Nutrition
n=75 Participants
Those with inadequate oral in take and a documented unmet need for artificial nutrition support for 4 or more days before engraftment.
|
|---|---|---|---|
|
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
Acute GvHD grade II-IV
|
75 Participants
|
73 Participants
|
31 Participants
|
|
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
Gut Acute GvHD any grade
|
63 Participants
|
63 Participants
|
27 Participants
|
PRIMARY outcome
Timeframe: 100 days after the date of hematopoietic cell infusionDefined as death without previous relapse
Outcome measures
| Measure |
Adequate Enteral Nutrition
n=245 Participants
Adequate nutrition in the period to engraftment after transplant, in those patients nourished orally or any patient that required 4 or more days of enteral tube feeding.
|
Adequate Parenteral Nutrition
n=148 Participants
Patients that were adequately nourished during the period to engraftment after transplant, that received 4 or more days of parenteral nutrition.
|
Inadequate Nutrition
n=91 Participants
Those with inadequate oral in take and a documented unmet need for artificial nutrition support for 4 or more days before engraftment.
|
|---|---|---|---|
|
Non Relapse Mortality
|
8.2 percentage of participants
Interval 5.0 to 12.0
|
17.6 percentage of participants
Interval 12.0 to 25.0
|
27.5 percentage of participants
Interval 20.0 to 38.0
|
SECONDARY outcome
Timeframe: 5 years after the date of hematopoietic cell infusionGvHD-free/relapse-free survival (GRFS). Events in GRFS included grade 3-4 acute GvHD, systemic therapy-requiring chronic GvHD, relapse, or death
Outcome measures
| Measure |
Adequate Enteral Nutrition
n=245 Participants
Adequate nutrition in the period to engraftment after transplant, in those patients nourished orally or any patient that required 4 or more days of enteral tube feeding.
|
Adequate Parenteral Nutrition
n=148 Participants
Patients that were adequately nourished during the period to engraftment after transplant, that received 4 or more days of parenteral nutrition.
|
Inadequate Nutrition
n=91 Participants
Those with inadequate oral in take and a documented unmet need for artificial nutrition support for 4 or more days before engraftment.
|
|---|---|---|---|
|
Graft Versus Host Disease-free and Relapse-free Survival
|
39.183 percentage of participants
Interval 33.0 to 46.0
|
29.729 percentage of participants
Interval 22.0 to 39.0
|
27.472 percentage of participants
Interval 17.0 to 39.0
|
SECONDARY outcome
Timeframe: 5 years after the date of hematopoietic cell infusionOutcome measures
| Measure |
Adequate Enteral Nutrition
n=245 Participants
Adequate nutrition in the period to engraftment after transplant, in those patients nourished orally or any patient that required 4 or more days of enteral tube feeding.
|
Adequate Parenteral Nutrition
n=148 Participants
Patients that were adequately nourished during the period to engraftment after transplant, that received 4 or more days of parenteral nutrition.
|
Inadequate Nutrition
n=91 Participants
Those with inadequate oral in take and a documented unmet need for artificial nutrition support for 4 or more days before engraftment.
|
|---|---|---|---|
|
5 Year Survival
|
53.877 percentage of participants
Interval 48.0 to 61.0
|
45.946 percentage of participants
Interval 38.0 to 55.0
|
41.758 percentage of participants
Interval 32.0 to 53.0
|
Adverse Events
Adequate Enteral Nutrition
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Adequate Parenteral Nutrition
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Inadequate Nutrition
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place