LeukemiaPhase 3NCT03016130
Comparing Two Diets in Patients Undergoing HSCT or Remission Induction Chemo for Acute Leukemia and MDS (UF-BMT-LDND-101)
A Phase 3 study testing Diet in people with Leukemia and Myelodysplastic Syndromes, run by University of Florida at 1 site in United States.
Trial summary
This is an open-label, two-arm, phase III non-inferiority trial to evaluate the safety of a liberalized hospital diet inclusive of fresh fruits and vegetables to a neutropenic diet in patients with prolonged neutropenia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Leukemia, Myelodysplastic Syndromes
- What is being tested?
- Diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 217 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Aug 2017to 16 May 2024
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 years or older
- Undergoing treatment for hematologic malignancies or HSCT as outlined below:
- Underlying diagnosis for non-HSCT patients:
- Acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS) receiving induction or reinduction chemotherapy; OR
- Acute lymphoblastic leukemia (ALL) receiving an intensive induction chemotherapy (e.g., HyperCVAD±R, CALGB9251, Larsons protocol) with an expected duration of neutropenia of ≥7 days; OR
- Allogeneic or autologous HSCT for any indication. For patients undergoing reduced intensity conditioning, only those regimens in which the expected neutropenia is ≥ 7 days are permitted and the patient must reside in the hospital
- Expected duration of neutropenia of ≥ 7 days
Who cannot join
- Use of anti infectives for treatment of active systemic infections within 7 days prior to initiation of study diet
- Untreated major infection at presentation
- Patients with uncontrolled invasive fungal infection (defined as those who have not completed at least 6 weeks of treatment; or who are symptomatic with two CT scans, at least 1 week apart showing uncontrolled disease at the time of initiation of study diet)
- Uncontrolled HIV, Hepatitis B and C infection
- Receipt of nutrition via enteral tube or total parenteral nutrition at the time of enrollment
- Patients unwilling to eat fresh fruit and/or vegetables
- Planned management of neutropenia in the outpatient setting
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase III, Randomized, Clinical Trial Comparing Two Diets in Patients Undergoing Hematopoietic Stem Cell Transplant (HSCT) or Remission Induction Chemotherapy for Acute Leukemia and Myelodysplastic Syndrome (UF-BMT-LDND-101)
This is an open-label, two-arm, phase III non-inferiority trial to evaluate the safety of a liberalized hospital diet inclusive of fresh fruits and vegetables to a neutropenic diet in patients with prolonged neutropenia. Both cohorts and diets will adhere to the hygiene and common sense advice listed in the FDA-endorsed food safety guidelines.
- Conditions
- Leukemia, Myelodysplastic Syndromes
- Being tested
- Diet
- Keywords
- leukemia, myelodysplastic, myeloid, lymphoblastic, diet, infection, hematopoietic, stem cell, transplant
- Medical subject headings
- Leukemia, Myelodysplastic Syndromes, Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DietOther
Diet Intervention: Subjects will undergo stratified randomization to account for the heterogeneous population, to receive one of the two diets: liberalized hospital diet (Diet A) or a neutropenic diet (Diet B).
| Study group | Role | What they receive |
|---|---|---|
| Liberalized Hospital Diet (Diet A) | Active comparator | Diet A would include fresh fruits and/or fresh vegetables in a liberalized hospital diet, and subjects will be encouraged to eat at least one daily serving of fresh fruits and/or vegetables. Receives: Other: Diet |
| Neutropenic Diet (Diet B) | Active comparator | Diet B is the hospital neutropenic diet. Receives: Other: Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of major infections
The primary objective of the trial is to compare the incidence of major infections in subjects undergoing HSCT or receiving induction chemotherapy for acute leukemia with prolonged neutropenia (less than or equal to 7 days) who are receiving either Diet A or Diet B.
Measured: 1 year
Secondary outcomes (10)
Incidence of infections in each diet group
This secondary objective of the trial is to compare the impact of diet on severe infections including: septic shock, bloodstream infection, invasive fungal infection, upper respiratory infection, infectious \& non-infectious pneumonia, C. difficile infection, Vancomycin-resistant \& -sensitive enterococcal colonization, Vancomycin-resistant \& -sensitive enterococcal infections, febrile neutropenia, typhlitis, lower tract respiratory viral infections, infection-related mortality, and admission to the ICU.
Measured: 1 year
Admission frequency
This secondary objective of the trial will examine the admission frequency to the intensive care unit (ICU).
Measured: 1 year
Compliance
This secondary objective of the trial will evaluate the degree of compliance to each diet from the time of initiation of the diet intervention until either the Absolute Neutrophil Count (ANC) is equal to or less than 500/mm3, the subject is discharged from the hospital, the subject is transferred from the unit, or after 30 days of ANC less than 500/mm3.
Measured: 1 year
Patient-Generated Subjective Global Assessment (PG-SGA)
This secondary objective of the trial will evaluate the impact of each diet on nutritional status as assessed by PG-SGA.
Measured: 1 year
Incidence of mucositis
This secondary objective of the trial will evaluate the impact of mucositis on dietary intake.
Measured: 1 year
Symptom incidence
This secondary objective of the trial is to compare symptoms between diets using the MDASI tool.
Measured: 1 year
Quality of life (QoL)
This secondary objective of the trial is to compare the QoL between diets as assessed by FACT-G.
Measured: 1 year
Overall survival (OS)
This secondary objective of the trial is to evaluate OS from 1 year following randomization
Measured: 1 year
Progression free survival (PFS)
This secondary objective of the trial is to evaluate PFS from 1 year following randomization
Measured: 1 year
Incidence of graft vs.host disease (GVHD)
This secondary objective of the trial is to evaluate the incidence of GVHD in allogeneic HSCT subjects only.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2017 (estimated)
- Study start18 Aug 2017
- Primary completion29 May 2023
- Study completion16 May 2024
Why it stopped: Interim analysis determined that study reached a safety stopping rule
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for LeukemiaStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 217 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Paul Crispen, MD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03016130
- Sponsor's protocol ID
- IRB201700581
- Other IDs
- UF-BMT-LDND-101, OCR15632, UF-HEM-007
- Status last verified
- Apr 2025
- First submitted
- 6 Jan 2017
- Last updated
- 7 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Wingard JR, Lee JH, Li D, Al-Mansour Z, Farhadfar N, Hsu J, Hiemenz J, Dean EA, Brown R, Trikha G, Schulz JN, Cline CL, Leather H, Sugrue MW, Dahl WJ, McGee KH, Leggett A, Kelly DL. Randomized Noninferiority Trial of a Liberalized Diet Versus the Neutropenic Diet in Hematopoietic Stem-Cell Transplant Patients and Patients With Acute Leukemia. J Clin Oncol. 2026 Feb;44(4):300-310. doi: 10.1200/JCO-25-00889. Epub 2025 Dec 17.
PubMed 41406403
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III, Randomized, Clinical Trial Comparing Two Diets in Patients Undergoing Hematopoietic Stem Cell Transplant (HSCT) or Remission Induction Chemotherapy for Acute Leukemia and Myelodysplastic Syndrome (UF-BMT-LDND-101)
- ClinicalTrials.gov ID
- NCT03016130
- Acronym / sponsor ID
- IRB201700581
- Conditions
- Leukemia, Myelodysplastic Syndromes
- Keywords
- leukemia, myelodysplastic, myeloid, lymphoblastic, diet, infection, hematopoietic, stem cell
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Interim analysis determined that study reached a safety stopping rule
- Enrolment
- 217 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Study start
- 18 Aug 2017 (actual)
- Primary completion
- 29 May 2023 (actual)
- Study completion
- 16 May 2024 (actual)
- First posted
- 10 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an open-label, two-arm, phase III non-inferiority trial to evaluate the safety of a liberalized hospital diet inclusive of fresh fruits and vegetables to a neutropenic diet in patients with prolonged neutropenia. Both cohorts and diets will adhere to the hygiene and common sense advice listed in the FDA-endorsed food safety guidelines.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Liberalized Hospital Diet (Diet A) | Active comparator | Other: DietDiet A would include fresh fruits and/or fresh vegetables in a liberalized hospital diet, and subjects will be encouraged to eat at least one daily serving of fresh fruits and/or vegetables. |
| Neutropenic Diet (Diet B) | Active comparator | Other: DietDiet B is the hospital neutropenic diet. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age 18 years or older
- Undergoing treatment for hematologic malignancies or HSCT as outlined below:
- Underlying diagnosis for non-HSCT patients:
- Acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS) receiving induction or reinduction chemotherapy; OR
- Acute lymphoblastic leukemia (ALL) receiving an intensive induction chemotherapy (e.g., HyperCVAD±R, CALGB9251, Larsons protocol) with an expected duration of neutropenia of ≥7 days; OR
Key exclusion criteria (7 listed)
- Use of anti infectives for treatment of active systemic infections within 7 days prior to initiation of study diet
- Untreated major infection at presentation
- Patients with uncontrolled invasive fungal infection (defined as those who have not completed at least 6 weeks of treatment; or who are symptomatic with two CT scans, at least 1 week apart showing uncontrolled disease at the time of initiation of study diet)
- Uncontrolled HIV, Hepatitis B and C infection
- Receipt of nutrition via enteral tube or total parenteral nutrition at the time of enrollment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DietDiet Intervention: Subjects will undergo stratified randomization to account for the heterogeneous population, to receive one of the two diets: liberalized hospital diet (Diet A) or a neutropenic diet (Diet B). | Other | Liberalized Hospital Diet (Diet A), Neutropenic Diet (Diet B) |
Primary outcome
Incidence of major infections
Time frame: 1 year
The primary objective of the trial is to compare the incidence of major infections in subjects undergoing HSCT or receiving induction chemotherapy for acute leukemia with prolonged neutropenia (less than or equal to 7 days) who are receiving either Diet A or Diet B.
10 secondary outcomes
Incidence of infections in each diet group
Time frame: 1 year
Admission frequency
Time frame: 1 year
Compliance
Time frame: 1 year
Patient-Generated Subjective Global Assessment (PG-SGA)
Time frame: 1 year
Incidence of mucositis
Time frame: 1 year
Symptom incidence
Time frame: 1 year
Quality of life (QoL)
Time frame: 1 year
Overall survival (OS)
Time frame: 1 year
Progression free survival (PFS)
Time frame: 1 year
Incidence of graft vs.host disease (GVHD)
Time frame: 1 year
Results and safety
The study was stopped early (reason given: Interim analysis determined that study reached a safety stopping rule). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2025.
- Derived from this study: PubMed 41406403Wingard JR, Lee JH, Li D, Al-Mansour Z, Farhadfar N, Hsu J, Hiemenz J, Dean EA, Brown R, Trikha G, Schulz JN, Cline CL, Leather H, Sugrue MW, Dahl WJ, McGee KH, Leggett A, Kelly DL. Randomized Noninferiority Trial of a Liberalized Diet Versus the Neutropenic Diet in Hematopoietic Stem-Cell Transplant Patients and Patients With Acute Leukemia. J Clin Oncol. 2026 Feb;44(4):300-310. doi: 10.1200/JCO-25-00889. Epub 2025 Dec 17.
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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.
Paul Crispen, MD principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Diet in people with Leukemia and Myelodysplastic Syndromes, run by University of Florida at 1 site in United States.
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 7 inclusion and 7 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: stopped early, as of the sponsor's last update on 7 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Interim analysis determined that study reached a safety stopping rule). Results are not available in the source record.
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?
Incidence of major infections (time frame: 1 year). 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 NCT03016130, which also lists 1 linked publication.
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 7 Apr 2025; AzTrials last refreshed its copy on 1 Nov 2026.