An Open Label, Prospective, Randomized, Comparative Clinical study to Evaluate the effects of AFO-202 strain of Aureobasidium Pullulans Produced β1,3-16 Glucans (Nichi BRITE) in patients with hematological malignancies undergoing myeloablative chemotherapy before hematopoietic stem cell transplantation (HSCT)

Study Design: This is a OpenLabel, Prospective, Randomized, Comparative Clinical Study

Indication: Hematological malignancies

Investigational Product:Nichi BRITE Beta-glucan   Comparator: None. Subjects in comparator arm will be receiving Chemotherapy no interventions are given. Dose: 1.5g Dosage:  Two sachets per day

Treatment Duration: 24 days

Route of Administration: Oral

Subject Population: Children scheduled for myeloablative chemotherapy before HSCT.

Number of Subjects: 40 Evaluable Subjects Treatment Arms:  Two Treatment Arms Treatment arm I   : Chemotherapy and Nichi BRITE Beta-glucan Treatment arm II  : Chemotherapy

Assessments : Blood Markers : CD209,CD4, CD8, CD16, CD56) and IgA, SAA, Butryate levels Timepoints : Baseline, Day 0, Day 7, Day 14, Day 21, Day 24

Background of the study: Hematopoietic stem cell transplantation (HSCT) is a treatment for life threatening diseases like hematopoietic malignancies, using stem cells from bone marrow or peripheral blood. The administration of beta glucan improves patient outcome during chemotherapy by modifying the immune system, gut microbiome and increasing endogenous butyrate levels.

**Purpose of the Study:**Nichi BRITE Beta-glucan, a water-soluble food supplement produced by the AFO-202 strain of Aureobasidium pullulans manufactured in Japan in a GMP facility. Nichi BRITE, an onconutrition adjuvant, has been proven to enhance immune biomarkers and decrease cancer-associated markers in pancreatic cancer patients. Therefore, this study is designed to evaluate the effects of Nichi BRITE Beta-glucan in children undergoing myeloablative chemotherapy before HSCT.