Clinical trial · Interventional
Comparing Two Diets in Patients Undergoing HSCT or Remission Induction Chemo for Acute Leukemia and MDS (UF-BMT-LDND-101)
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)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Interim analysis determined that study reached a safety stopping rule
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Leukemia | Leukemia | ONTOLOGY_EXACT | 0.90 |
| Myelodysplastic Syndromes | Myelodysplastic Syndrome | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Diet | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Liberalized Hospital Diet (Diet A)
- description
- 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.
- interventionNames
- Other: Diet
- type
- ACTIVE_COMPARATOR
- label
- Neutropenic Diet (Diet B)
- description
- Diet B is the hospital neutropenic diet.
- interventionNames
- Other: Diet
Primary outcomes (1)
- measure
- Incidence of major infections
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Exclusion Criteria: * 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
References
Publications (1)
- DERIVEDWingard 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. PMID 41406403