Multiple Myeloma Clinical Trial
Lactobacillus Plantarum in Preventing Acute Graft Versus Host Disease in Children Undergoing Donor Stem Cell Transplant
This randomized phase III trial studies how well Lactobacillus plantarum works in preventing acute graft versus host disease in children undergoing donor stem cell transplant. Lactobacillus plantarum may help prevent the development of gastrointestinal graft versus host disease in children, adolescents, and young adults undergoing donor stem cell transplant.
I. To determine efficacy of orally-administered Lactobacillus plantarum (LBP) in preventing the development of gastrointestinal (GI) acute graft versus host disease (aGvHD) in children and adolescents undergoing alternative donor allogeneic hematopoietic cell transplantation (alloHCT).
I. To determine whether orally-administered LBP decreases the incidence of grade II-IV aGvHD following alternative donor alloHCT.
II. To determine whether LBP administration maintains intestinal integrity as measured by mean serum citrulline levels and reduction in mucosal barrier injury (MBI) bacteremia.
III. To measure the effects of LBP on the intestinal flora phylogenetic composition during and after alternative donor alloHCT using 16S ribosomal ribonucleic acid (rRNA) gene deep sequencing.
IV. To measure effects of LBP on intestinal flora function during and after alternative donor alloHCT using metagenomic and metabolite profiling.
V. To measure proposed immunomodulatory effects of LBP in mean serum levels of alloreactive-induced inflammatory cytokines (IL-2, IL-6, IL-12p70, IFN gamma, TNF alpha, etc) in patients receiving LBP compared to placebo.
VI. To determine whether LBP administration reduces the incidence of Clostridium difficile-associated diarrhea in alternative donor HCT patients.
VII. To determine whether LBP administration reduces hospital days within the first 120 days post hematopoietic cell transplant (HCT).
VIII. 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.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients receive Lactobacillus plantarum strains 299 and 299v orally (PO) or through nasojejunal (NJ), nasogastric (NG) or gastronomy (G) tube once daily (QD) on day 1 of transplant conditioning regimen to 56 days post alloHCT. Patients undergo alloHCT at day 0.
ARM II: Patients receive placebo PO or through NJ, NG or G tube QD on day 1 of transplant conditioning regimen to 56 days post alloHCT. Patients undergo alloHCT at day 0.
After completion of study treatment, patients are followed up for 120 days from alloHCT.
All clinical and laboratory studies, if applicable, must be obtained within 21 days prior to start of protocol therapy (repeat if necessary); protocol therapy must begin within 6 months of study enrollment
Patient must have a diagnosis that is managed with an alternative donor allogeneic hematopoietic cell transplant
Patients must have a Lansky (for patients =< 16 years of age) or Karnofsky (for patients > 16 years of age) performance status score of >= 70; patients who are unable to walk because of a chronic underlying condition (such as paralysis), but who are up in a wheelchair, will be considered ambulatory for the purpose of assessing performance score
Hematopoietic cell transplant (HCT)
Patient must be receiving cells from alternative donor defined as one of the following:
Unrelated donor with a complete human leukocyte antigen (HLA) match or a 1 or 2 HLA mismatch, considering only HLA-A, HLA-B, HLA-C, and HLA-DRB1
Related donor with a 1 or more HLA mismatch (including haplo-identical)
Note: History of HCT or other cellular therapy (e.g. chimeric antigen receptor [CAR]-T cells, donor lymphocyte infusions) is permitted
Patient plans on receiving stem cells from a matched (8/8) related donor
Patient has used a probiotic dietary supplement within the previous 30 days of enrollment; (consumption of yogurt products is allowed)
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), history of gastrointestinal GVHD, or history of bowel resection
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
Female patients who are pregnant are not eligible; women of childbearing potential require a negative pregnancy test prior to enrollment
Patient has diarrhea at the time of enrollment which is Clostridium difficile toxin positive
Patient is receiving antibiotic therapy for an active bacterial infection
Patient is allergic to all third or fourth generation cephalosporins, carbapenems, and all aminoglycosides, which are used to empirically treat LBP bacteremia
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There are 43 Locations for this study
Birmingham Alabama, 35233, United States
Duarte California, 91010, United States
Los Angeles California, 90027, United States
Oakland California, 94609, United States
San Diego California, 92123, United States
San Francisco California, 94158, United States
Aurora Colorado, 80045, United States
New Haven Connecticut, 06520, United States
Wilmington Delaware, 19803, United States
Washington District of Columbia, 20010, United States
Gainesville Florida, 32610, United States
Jacksonville Florida, 32207, United States
Orlando Florida, 32827, United States
Saint Petersburg Florida, 33701, United States
Honolulu Hawaii, 96826, United States
Indianapolis Indiana, 46202, United States
New Orleans Louisiana, 70118, United States
Baltimore Maryland, 21287, United States
Boston Massachusetts, 02215, United States
Ann Arbor Michigan, 48109, United States
Grand Rapids Michigan, 49503, United States
Jackson Mississippi, 39216, United States
Kansas City Missouri, 64108, United States
Hackensack New Jersey, 07601, United States
Buffalo New York, 14263, United States
New York New York, 10032, United States
Rochester New York, 14642, United States
Valhalla New York, 10595, United States
Chapel Hill North Carolina, 27599, United States
Cleveland Ohio, 44195, United States
Columbus Ohio, 43205, United States
Oklahoma City Oklahoma, 73104, United States
Portland Oregon, 97239, United States
Philadelphia Pennsylvania, 19104, United States
Nashville Tennessee, 37203, United States
Nashville Tennessee, 37232, United States
Dallas Texas, 75230, United States
San Antonio Texas, 78207, United States
San Antonio Texas, 78229, United States
Madison Wisconsin, 53792, United States
Calgary Alberta, T3B 6, Canada
Toronto Ontario, M5G 1, Canada
Montreal Quebec, H3T 1, Canada
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