Protocol Summary

Protocol No.: 15632

Sponsor Protocol No.: UF-BMT-LDND-101

Study Title
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

Principal Investigator(s)
Murthy, Hemant

Objective
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.

Phase: Phase III

Age Group: Adult

Scope: Local

Treatment
Liberalized Hospital Diet (Diet A):
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.

Neutropenic Diet (Diet B):
Diet B is the hospital neutropenic diet.

Detailed Eligibility
INCLUSION CRITERIA:
1. Age 18 years or older
2. Undergoing treatment for hematologic malignancies or HSCT as outlined below:
3. Underlying diagnosis for non-HSCT patients:
4. Acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS) receiving induction or reinduction chemotherapy; OR
5. 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
6. 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
7. Expected duration of neutropenia of ≥ 7 days

EXCLUSION CRITERIA:
1. Use of systemic antibacterial antibiotics within 7 days prior to initiation of study diet
2. Untreated major infection at presentation
3. 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)
4. Uncontrolled HIV, Hepatitis B and C infection
5. Use of neutropenic diet within 72 hours prior to consent
6. Receipt of nutrition via enteral tube or total parenteral nutrition at the time of enrollment
7. Patients unwilling to eat fresh fruit and/or vegetables
8. Planned management

Applicable Disease Sites
Stem Cell Transplant
Supportive Care Trials

Participating Institutions
UF Gainesville

Contact
Zachary Hudson
Phone: 352-273-5263

Email: zachary.hudson@medicine.ufl.edu

More Information:
View study listing on ClinicialTrials.gov
http://www.clinicaltrials.gov/ct2/show/
NCT03016130