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
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.
- 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
KeywordsNeutropenia, Diet, Hematopoietic Stem Cell Transplant, Remission Induction Chemotherapy
Principal InvestigatorHemant Murthy, Clinical Assistant Professor
Sponsoring GroupDepartment of Medicine
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