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)

Overview

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.
SparkCures ID 1512
Trial Phase Phase 3
Enrollment 470 Patients
Tags
  • Randomization
Trial Sponsors
  • Shands Hospital
NCT Identifier

NCT03016130

CLOSED

This trial is active but is no longer accepting patients.

Am I Eligible?

The following criteria is a partial list of reasons why patients may or may not be eligible to participate in this clinical trial. Further evaluation with a medical professional will be required to determine full eligibility.

The following criteria is provided for health care professionals.

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

US Trial Locations

Please visit the ClinicalTrials.gov page for historical site information.

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