Lactobacillus Plantarum in Preventing Acute Graft Versus Host Disease in Children Undergoing Donor Stem Cell Transplant
Condition: Hematopoietic and Lymphoid System Neoplasm; Leukemia; Lymphoma
MeSH terms: Graft vs Host Disease
Intervention: Allogeneic Hematopoietic Stem Cell Transplantation; Lactobacillus plantarum strain 299; Lactobacillus plantarum strain 299v; Placebo Administration
Intervention description: Undergo alloHCT; Given PO or via NJ, NG or G tube; Given PO or via NJ, NG or G tube; Given PO or via NJ, NG or G tube
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 173.0
Sex: All
Minimum age: 2 Years
Maximum age: 25 Years
Healthy volunteers: No

Summary:

      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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  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

        Exclusion Criteria:

          -  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