Trial to Compare Diets in Patients With Leukemia or MDS and Prolonged Neutropenia

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Title: Comparing Two Diets in Patients Undergoing HSCT or Remission Induction Chemo for Acute Leukemia and MDS

Principal Investigator: Zeina A. Al-Mansour, MD, University of Florida

Description: Investigators are conducting a phase 3 non-inferiority trial to compare a neutropenic diet with a liberalized hospital diet in patients with myelodysplastic syndromes (MDS) or acute leukemia who have prolonged neutropenia.


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Both cohorts and diets will adhere to food safety guidelines endorsed by the US Food and Drug Administration.

Diet A will consist of fresh fruits and/or vegetables in a liberalized hospital diet. Patients will be encouraged to eat at least 1 daily serving of fresh fruits and/or vegetables. Diet B consists of the hospital neutropenic diet.

The trial’s primary objective is to compare the incidence of major infections with Diet A and Diet B in patients treated with hematopoietic stem cell transplant (HSCT) or induction chemotherapy who have prolonged neutropenia (lasting 7 days or fewer).

Secondary endpoints include severe infections (such as septic shock and invasive fungal infection), ICU admission, compliance, nutritional status, mucositis, symptoms, quality of life, progression-free and overall survival, and graft-vs-host disease.

To be eligible for the study, patients should be 18 years or older, have acute lymphoblastic leukemia, acute myeloid leukemia, or MDS. They must be undergoing allogeneic/autologous HSCT or receiving induction/reinduction chemotherapy. For a complete list of eligibility criteria, please refer to the reference.

Status: Recruiting

This study is sponsored by the University of Florida.

Reference

Clinicaltrials.gov. Comparing Two Diets in Patients Undergoing HSCT or Remission Induction Chemo for Acute Leukemia and MDS (UF-BMT-LDND-101). NCT03016130. Accessed October 20, 2021.



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