IRB Study Number 19-507
Status Recruiting
Phase Phase 3
Institutes Taussig Cancer Institute, Pediatric Institute
Description
Primary Aim
To determine efficacy of orally-administered LBP in preventing the development of GI aGvHD in children and adolescents undergoing alternative donor alloHCT.
1.2 Exploratory Aims
1 To determine whether orally-administered LBP decreases the incidence of Grade II–IV aGvHD following alternative donor alloHCT.
2 To determine whether LBP administration maintains intestinal integrity as measured by mean serum citrulline levels and reduction in mucosal barrier injury (MBI) bacteremia.
3 To measure the effects of LBP on the intestinal flora phylogenetic composition during and after alternative donor alloHCT using 16S rRNA gene deep sequencing.
4 To measure effects of LBP on intestinal flora function during and after alternative donor alloHCT using metagenomic and metabolite profiling.
5 To measure proposed immunomodulatory effects of LBP in mean serum levels of alloreactive-induced inflammatory cytokines (IL-2, IL-6, IL-12p70, IFN, TNF, etc.) in patients receiving LBP compared to placebo.
6 To determine whether LBP administration reduces the incidence of Clostridium difficile-associated diarrhea in alternative donor HCT patients.
7 To determine whether LBP administration reduces hospital days within the first 120 days post hematopoietic cell transplant (HCT).
8 To define the safety of orally administered LBP strains 299 and 299v in alternative donor HCT patients as measured by incidence of Lactobacillus plantarum bacteremia.
Inclusion Criteria
1 Age: Patient must be ≥ 2 years of age and ≤ 25 years of age at time of enrollment.
2 Diagnosis: Patient must have a diagnosis that is managed with an alternative donor allogeneic hematopoietic cell transplant.
3 Performance Level: Patients must have a performance status corresponding to ECOG scores of 0 or 1 (≥ 70% for Karnofsky/Lansky). Use Karnofsky for patients > 16 years of age and Lansky for patients 16 years of age. See
https://members.childrensoncologygroup.org/prot/reference\_materials.asp under Standard Sections for Protocols.
4 Hematopoietic Cell Transplant (HCT): Patient must be receiving cells from alternative donor defined as one of the following:
a. Unrelated donor with a complete HLA match or a 1 or 2 HLA mismatch.
b. Related donor with a 1 or more HLA mismatch (including haplo-identical).
Note: history of HCT or other cellular therapy (e.g., CAR-T cells, donor lymphocyte infusions) is permitted.
Exclusion Criteria
1 Patient plans on receiving stem cells from a matched (8/8) related donor.
2 Patient has used a probiotic dietary supplement within 30 days prior to enrollment. (Consumption of yogurt products is allowed.)
3 Patient has a history of severe GI tract insult including but not limited to previous bowel perforation, Grade 4 neutropenic colitis or typhlitis, inflammatory bowel syndrome, short small bowel syndrome (Crohn’s disease, ulcerative colitis) or history of bowel resection.
4 Patient has a medical, psychiatric or social issue that would compromise patient safety or compliance with protocol therapy, or interfere with consent, study participation, follow up, or interpretation of study results.
5 Female patients who are pregnant are not eligible. Women of childbearing potential require a negative pregnancy test prior to enrollment.
6 Patient has diarrhea at the time of enrollment which is Clostridium difficile toxin positive.
7 Patient is receiving antibiotic therapy for an active infection.
8 Patient is allergic to the third or fourth generation cephalosporins, carbapenems, or aminoglycosides which are used to empirically treat LBP bacteremia.
