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

Purpose

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.

Eligibility

  • 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

Age

18 to 65
65 and over

Gender

Male
Female

Keywords

Neutropenia, Diet, Hematopoietic Stem Cell Transplant, Remission Induction Chemotherapy

Principal Investigator

Hemant Murthy, Clinical Assistant Professor

Sponsoring Group

Department of Medicine

Department

Department of Medicine

Contact Information

hemant.murthy@ufl.edu

352.265.0725


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