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Clinical Trials/NCT03016130
NCT03016130TerminatedPhase 3

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)

University of Florida2 sites in 1 country217 target enrollmentStarted: August 18, 2017Last updated:
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Conditions

Trial Snapshot

Phase
Phase 3
Status
Terminated
Enrollment
217
Locations
2
Primary Endpoint
Incidence of major infections
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Supportive Care
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

Incidence of major infections

Time Frame: 1 year

The primary objective of the trial is to compare the incidence of major infections in subjects undergoing HSCT or receiving induction chemotherapy for acute leukemia with prolonged neutropenia (less than or equal to 7 days) who are receiving either Diet A or Diet B.

Secondary Outcomes

  • Incidence of mucositis(1 year)
  • Symptom incidence(1 year)
  • Patient-Generated Subjective Global Assessment (PG-SGA)(1 year)
  • Quality of life (QoL)(1 year)
  • Admission frequency(1 year)
  • Incidence of infections in each diet group(1 year)
  • Compliance(1 year)
  • Overall survival (OS)(1 year)
  • Progression free survival (PFS)(1 year)
  • Incidence of graft vs.host disease (GVHD)(1 year)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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