Spots Global Cancer Trial Database for CBM588 in Improving Clinical Outcomes in Patients Who Have Undergone Donor Hematopoietic Stem Cell Transplant

Study Description

Brief Summary: This pilot trial studies the side effects and how well CBM588 works in improving clinical outcomes in patients who have undergone donor hematopoietic stem cell transplant. Gut microbiota (formerly called gut flora) is the name given to the microbe (bacteria) population living in the intestine. Gut bacteria help the body to digest certain foods that the stomach and small intestine have not been able to digest. CBM588, may increase gut bacteria biodiversity, prevent recurrent symptoms of gastrointestinal toxicity (ranging from diarrhea to life-threatening inflammation of the colon).

Detailed Description: PRIMARY OBJECTIVES: I. In patients with hematologic malignancies who are undergoing standard reduced intensity conditioning regimen (RIC) prior to allogeneic stem cell transplantation, to evaluate the safety and feasibility of Clostridium butyricum CBM 588 probiotic strain (CBM588) treatment by assessing: Ia. Type, frequency, severity, attribution, time course and duration of adverse events, including diarrhea, bloodstream/intestinal infections. Ib. Patient compliance, the patients' ability to take CBM588 during the treatment period. SECONDARY OBJECTIVES: I. Compare the incidence and severity of adverse events (AE) among CBM588-treated and untreated patients, including diarrhea, bloodstream infections and intestinal infections. II. Estimate overall survival (OS), cumulative incidence (CI) of chronic graft versus host disease (GVHD), relapse/progression, and non-relapse mortality (NRM) at 100 days, 6 months, 1 year and 2 years. EXPLORATORY OBJECTIVES: I. Compare gut microbiome diversity among CBM588-treated/untreated patients. II. Obtain a preliminary estimate of the possible association between gut microbiome diversity and bloodstream infections. III. Characterize and compare graft versus host disease (GVHD) inflammatory biomarkers (presence, level) among CBM588-treated and untreated patients. IV. Obtain preliminary estimates of gut microbiome diversity, as assessed by the inverse Simpson Index, in CBM588-treated/untreated patients. V. Obtain a preliminary estimate of the possible association between gut microbiome diversity and acute GVHD cumulative incidence, including time to onset. VI. Characterize and compare urinary uindoxyl sulfate, tryptophan and kynurenine levels between CBM588- treated and untreated patients. VII. To obtain a preliminary estimate of gut microbiome diversity and calorie intake. VIII. Characterize and compare impact of CBM588 administration on regulatory T cells (T regs) reconstitution between CBM588-treated and untreated patients. OUTLINE: Patients are randomized to 1 of 2 arms. ARM I (CBM588): Patients receive standard peri-/post-transplant supportive care and CBM588 orally (PO) twice daily (BID) from day of admission to day 28 in the absence of disease progression or unacceptable toxicity. ARM II (STANDARD OF CARE): Patients receive standard peri-/post-transplant supportive care. After completion of study treatment, patients are followed up for 100 days and then up to 2 years.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Contact Details

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