Comparing Two Diets in Patients Undergoing HSCT or Remission Induction Chemo for Acute Leukemia and MDS (UF-BMT-LDND-101)

NCT03016130 | Terminated Phase 3 DMC

• 4 other identifiers: IRB201700581UF-BMT-LDND-101OCR15632UF-HEM-007
• Study Type: interventional
• Target: 217
• Locations: 1 country
• Sites: 1

Brief 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. 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

Keywords

leukemia; myelodysplastic; myeloid; lymphoblastic; diet; infection; hematopoietic; stem cell; transplant

Outcome Measures

Primary Outcomes (1)

• 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.

  1 year

Secondary Outcomes (10)

• Incidence of infections in each diet group

  1 year

• Admission frequency

  1 year

• Compliance

  1 year

• Patient-Generated Subjective Global Assessment (PG-SGA)

  1 year

• Incidence of mucositis

  1 year

Study Arms (2)

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.

Other: Diet

Neutropenic Diet (Diet B)

ACTIVE COMPARATOR

Diet B is the hospital neutropenic diet.

Other: Diet

Interventions

Diet OTHER

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).

Liberalized Hospital Diet (Diet A); Neutropenic Diet (Diet B)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Florida: lead

Study Sites (1)

UF Health Cancer Center

Gainesville, Florida, 32608, United States

Location

Related Publications (1)

• 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.

  PMID: 41406403 DERIVED

MeSH Terms

Conditions

Leukemia; Myelodysplastic Syndromes; Infections

Interventions

Diet

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Bone Marrow Diseases

Intervention Hierarchy (Ancestors)

Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Paul Crispen, MD

  University of Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 6, 2017
• First Posted: January 10, 2017
• Study Start: August 18, 2017
• Primary Completion: May 29, 2023
• Study Completion: May 16, 2024
• Last Updated: April 7, 2025

Record last verified: 2025-04

Locations

US (1)