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Protocol No. ACCL1633

Principal Investigator DeSantes, Kenneth

Phase III (Cancer Control)

Age Group Both

Scope National

Sponsor Type National

Title The Effectiveness of Lactobacillus plantarum (LBP, IND# 17339) in Preventing Acute Graft-versus-Host Disease (GvHD) in Children undergoing Alternative Hematopoietic Progenitor Cell Transplantation (HCT)

Objective The overall goal of this study is to find out if the probiotic Lactobacillus plantarum (LBP) will prevent the development of GI aGvHD in children, adolescents and young adults undergoing alternative alloHCT

Treatment Participants in this study will drink water or juice mixed either the probiotic Lactobacillus plantarum (LBP) or placebo. The amount you will drink depends on how much you weigh. You will be asked to drink your mixture once a day starting on the first day of the conditioning regimen (the first day chemotherapy and/or radiation therapy is given) for HCT and for 56 days after your transplant. If you go home before Day 56 after transplant, you will take your mixture at home. The study team will follow you for 120 days (about 4 months) after your transplant to monitor how you are doing and to see if you develop GvHD

Description Phase III study testing the effectiveness of Lactobacillus plantarum (LBP) in preventing Acute Graft-versus-Host

Key Eligibility
  • Patient must be greater than or equal to 2 years of age and less than or equal to 25 years of age at time of enrollment
  • Patient must have a diagnosis that is managed with an alternative donor allogeneic hematopoietic cell transplant
  • Patients must have a performance status corresponding to ECOG scores of 0 or 1 (greater than or equal to 70% for Karnofsky/Lansky). Use Karnofsky for patients greater than 16 years of age and Lansky for patients less than 16 years of age
    Hematopoietic Cell Transplant (HCT)
  • No previous history of HCT or other cellular therapy (e.g., CAR-T cells, donor lymphocyte infusions)
    Patient must be receiving cells from a first alternative donor defined as one of the following:
  • Unrelated donor with a complete HLA match or a 1 or 2 HLA mismatch
  • Related donor with a 1 or 2 HLA mismatch
    Exclusion Criteria
  • Patient plans on receiving stem cells from a matched (8/8) related donor
  • Patient plans on receiving stem cells from a donor who has a 3 or more HLA mismatch
  • Patient has used a probiotic dietary supplement within 30 days prior to 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 (CrohnÂ’s disease, ulcerative colitis) 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 infection
  • Patient is allergic to the third or fourth generation cephalosporins, carbapenems,or aminoglycosides which are used to empirically treat LBP bacteremia

  • Applicable Disease Sites Hematologic cancers, other; Leukemia

    Status Open

    Participating Institutions Gundersen Health System; UW Hospital and Clinics