Allogeneic Stem Cell TransplantNCT03419078

Nutrition and Outcomes of Hematopoietic Cell Transplantation (HCT)

An observational study of Allogeneic Stem Cell Transplant and Graft Versus Host Disease, run by Imperial College Healthcare NHS Trust.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 17 years and older
Conditions the study is for: Allogeneic Stem Cell Transplant, Graft Versus Host Disease, Hematologic Malignancy
How many people: 484 participants
Where: No sites listed yet
Study dates: Dec 2015to Nov 2016
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 17 years and older
All sexes
No healthy volunteers
Child, Adult, Older adult

Study population: 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

Who may be able to join

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

Who cannot join

HCT using umbilical cord blood donors
HCT using haploidentical donors

About this study

Official title: Route and Adequacy of Nutrition and Outcomes of Haematopoietic Cell Transplantation in Patients With Haematological Neoplasms

Retrospective case-note review to determine if nutrition via the enteral compared to the parenteral route results in better outcomes after haematopoietic cell transplantation.

Read the detailed description

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.

Conditions: Allogeneic Stem Cell Transplant, Graft Versus Host Disease, Hematologic Malignancy, Stem Cell Transplant Complications
Keywords: enteral nutrition, parenteral nutrition, artificial nutrition support, non-relapse mortality, survival
Medical subject headings: Graft vs Host Disease, Hematologic Neoplasms, Hyperphagia

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 100 days after the date of hematopoietic cell infusion
Non Relapse Mortality
Defined as death without previous relapse
Measured: 100 days after the date of hematopoietic cell infusion

Secondary outcomes (2)

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
Measured: 5 years after the date of hematopoietic cell infusion
5 Year Survival
Measured: 5 years after the date of hematopoietic cell infusion

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Dec 2015Nov 2016

First posted1 Feb 2018
Study startDec 2015
Primary completionJun 2016
Study completionNov 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Allogeneic Stem Cell TransplantStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Retrospective
Enrolment: 484 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03419078
Sponsor's protocol ID: 15HH2638
Status last verified: Sep 2019
First submitted: 26 Jan 2018
Last updated: 21 Oct 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

RecruitingObservational study
Improved Methods of Cell Selection for Bone Marrow Transplant Alternatives
Graft-Versus-Host Disease, Graft-versus-leukemia
Active, not recruitingPhase 2
Clofarabine and Melphalan Before Donor Stem Cell Transplant in Treating Patients With Myelodysplasia, Acute Leukemia in Remission, or Chronic Myelomonocytic Leukemia
Adult Acute Lymphoblastic Leukemia in Remission, Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome
RecruitingObservational study
Natural History Study to Determine Drug Metabolism Phenotype and Appropriate Germline Source DNA in Patients Undergoing Allogeneic Hematopoietic Stem Cell Transplant
Leukemia, Lymphoma
Enrolling by invitationPhase 2
Thiotepa + TBI + Fludarabine + Etoposide for Allo-HSCT in Patients With R/R or High-risk Acute Leukemia
Acute Leukemia, High Risk, Acute Leukemia Refractory
RecruitingPhase 1/2
Phase I/II Study of Pacritinib, A JAK2/IRAK1/CSF1R Inhibitor, in Refractory Chronic Graft-Versus-Host Disease (cGVHD) After Allogeneic Hematopoietic Stem Cell Transplantation (HSCT)
Graft vs Host Disease

All Allogeneic Stem Cell Transplant trials

Study at a glance

From the registry record, last updated by the sponsor on 21 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Route and Adequacy of Nutrition and Outcomes of Haematopoietic Cell Transplantation in Patients With Haematological Neoplasms
ClinicalTrials.gov ID: NCT03419078
Acronym / sponsor ID: 15HH2638
Conditions: Allogeneic Stem Cell Transplant, Graft Versus Host Disease, Hematologic Malignancy, Stem Cell Transplant Complications
Keywords: enteral nutrition, parenteral nutrition, artificial nutrition support, non-relapse mortality, survival
Study type: Observational
Recruitment status: Completed
Enrolment: 484 participants (actual)
Lead sponsor: Imperial College Healthcare NHS TrustUniversity, hospital or other
Study start: Dec 2015 (actual)
Primary completion: Jun 2016 (actual)
Study completion: Nov 2016 (actual)
First posted: 1 Feb 2018 (actual)
Results: Posted 21 Oct 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Retrospective case-note review to determine if nutrition via the enteral compared to the parenteral route results in better outcomes after haematopoietic cell transplantation.

Detailed description

Study design

Observational model: Cohort
Time perspective: Retrospective

Who may qualify

Ages: 17 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult
Study population: 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

Key inclusion criteria (3 listed)

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

Key exclusion criteria (2 listed)

HCT using umbilical cord blood donors
HCT using haploidentical donors

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

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
Time frame: 100 days after the date of hematopoietic cell infusion
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.
Non Relapse Mortality
Time frame: 100 days after the date of hematopoietic cell infusion
Defined as death without previous relapse

2 secondary outcomes

Graft Versus Host Disease-free and Relapse-free Survival
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

Results and safety

Results posted to the registry on 21 Oct 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Adequate Enteral Nutrition	245	245
Adequate Parenteral Nutrition	148	148
Inadequate Nutrition	91	91

Primary outcome: 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

Time frame: 100 days after the date of hematopoietic cell infusion. Count of participants. Unit: Participants

Measure	Adequate Enteral Nutrition n = 232	Adequate Parenteral Nutrition n = 132	Inadequate Nutrition n = 75
Acute GvHD grade II-IV	75	73	31
Gut Acute GvHD any grade	63	63	27

Population analysed: 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.

Primary outcome: Non Relapse Mortality

Time frame: 100 days after the date of hematopoietic cell infusion. Mean (95% Confidence Interval). Unit: percentage of participants

Measure	Adequate Enteral Nutrition n = 245	Adequate Parenteral Nutrition n = 148	Inadequate Nutrition n = 91
Value	8.2 (5 to 12)	17.6 (12 to 25)	27.5 (20 to 38)

2 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Adequate Enteral Nutrition	0 of 245 (0%)	0 of 245 (0%)	Not reported
Adequate Parenteral Nutrition	0 of 148 (0%)	0 of 148 (0%)	Not reported
Inadequate Nutrition	0 of 91 (0%)	0 of 91 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Allogeneic Stem Cell Transplant

RecruitingObservational study
Improved Methods of Cell Selection for Bone Marrow Transplant Alternatives
Graft-Versus-Host Disease, Graft-versus-leukemia
Active, not recruitingPhase 2
Clofarabine and Melphalan Before Donor Stem Cell Transplant in Treating Patients With Myelodysplasia, Acute Leukemia in Remission, or Chronic Myelomonocytic Leukemia
Adult Acute Lymphoblastic Leukemia in Remission, Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome
RecruitingObservational study
Natural History Study to Determine Drug Metabolism Phenotype and Appropriate Germline Source DNA in Patients Undergoing Allogeneic Hematopoietic Stem Cell Transplant
Leukemia, Lymphoma
Enrolling by invitationPhase 2
Thiotepa + TBI + Fludarabine + Etoposide for Allo-HSCT in Patients With R/R or High-risk Acute Leukemia
Acute Leukemia, High Risk, Acute Leukemia Refractory
RecruitingPhase 1/2
Phase I/II Study of Pacritinib, A JAK2/IRAK1/CSF1R Inhibitor, in Refractory Chronic Graft-Versus-Host Disease (cGVHD) After Allogeneic Hematopoietic Stem Cell Transplantation (HSCT)
Graft vs Host Disease

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

Questions about this trial

What is this clinical trial studying?

An observational study of Allogeneic Stem Cell Transplant and Graft Versus Host Disease, run by Imperial College Healthcare NHS Trust.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 21 Oct 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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 (time frame: 100 days after the date of hematopoietic cell infusion). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03419078.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2019.