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)

What's the purpose of this trial?

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.

This trial is currently open and accepting patients.

What will happen during the trial?

You may be able to join this trial if you:

The following criteria is a partial list of reasons why patients may be eligible to participate in this clinical trial. Further evaluation with a medical professional is required.

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

Additional Trial Information

Phase 3

Enrollment: 470 patients (estimated)

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Trial Locations

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University of Florida Health - Davis Cancer Pavilion

Gainesville, FL

Open and Accepting
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