acute leukemia, myelodysplastic syndrome, myeloproliferative neoplasm, malignant lymphoma, etc Hematologic malignanacy
Conditions
Interventions
1. CBM588 administration group
CBM588 fine granule 1g is orally administered 3 times daily from 7 days prior to transplantation until 100 days after transplantation.
2. placebo group
Placebo group: 1
Sponsors
Fukushima Kentaro
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Patients diagnosed with a malignant hematologic disease (acute leukemia, myelodysplastic syndrome, myeloproliferative neoplasm, malignant lymphoma, etc) that is an indication for an allogeneic hematopoietic stem cell transplant. Any source of transplant is acceptable. (2) Age 16 years or older but less than 70 years old. (3) Persons who have given written consent to participate in this study.
Exclusion criteria
Exclusion criteria: (1) Those with Very High DRI (2) Those with HCT-CI of 3 or more points (3) Patients who are currently participating in other interventional studies (4) Other subjects deemed inappropriate by the principal investigator or subinvestigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline (7 days before transplantation) in alpha diversity (Shannon index) at 14 days after transplantation | — |
Secondary
| Measure | Time frame |
|---|---|
| (1) Change from baseline in alpha diversity at each evaluation time point after transplantation (2) Change from baseline in beta diversity at each time point after transplantation (3) Change from baseline in Enterococcus and Bacteroides at each post-transplant evaluation time point (4) Change from baseline in butyrate-producing bacteria (and Clostridium butyricum) at each post-transplant evaluation time point (5) Frequency of onset of diarrhea (Bristol Scale 6 or 7) and duration of diarrhea in those who developed diarrhea after transplantation (6) Frequency of onset of fever > 38 degrees Celsius after transplantation and duration of fever (7) Frequency of febrile neutropenia after transplantation (8) Types of antimicrobial agents used in the treatment of post-transplant febrile neutropenia and the number of days they were used (9) Frequency of post-transplant complications including acute GVHD (10) Recurrence-free survival (including evaluation of non-relapse mortality) (11) Overall survival (12) Adverse events | — |
Contacts
Public ContactKentaro Fukushima
Osaka University Graduate School of Medicine
Outcome results
None listed