Lactobacillus Plantarum in Preventing Acute Graft Versus Host Disease in Children Undergoing Donor Stem Cell Transplant
Status: | Recruiting |
---|---|
Conditions: | Hematology |
Therapuetic Areas: | Hematology |
Healthy: | No |
Age Range: | 2 - 25 |
Updated: | 2/24/2019 |
Start Date: | April 30, 2018 |
End Date: | August 1, 2023 |
The Effectiveness of Lactobacillus Plantarum (LBP) in Preventing Acute Graft-Versus-Host Disease (GvHD) in Children Undergoing Alternative Hematopoietic Progenitor Cell Transplantation (HCT)
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.
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.
PRIMARY OBJECTIVES:
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 initial alternative donor allogeneic hematopoietic cell
transplantation (alloHCT).
SECONDARY OBJECTIVES:
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?, TNF?, 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 100 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
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 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.
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 initial alternative donor allogeneic hematopoietic cell
transplantation (alloHCT).
SECONDARY OBJECTIVES:
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?, TNF?, 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 100 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
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 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.
Inclusion Criteria:
- Patient must have a diagnosis that is managed with an alternative donor allogeneic
hematopoietic cell transplant
- Patients must have a performance status corresponding to Eastern Cooperative Oncology
Group (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
- Hematopoietic cell transplant (HCT)
- No previous history of HCT or other cellular therapy (e.g., chimeric antigen
receptor [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 human leukocyte antigen (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 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) 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 celphalosporins, carbapenem, or
aminoglycosides which are used to empirically treat LBP bacteremia
We found this trial at
31
sites
666 Elm Street
Buffalo, New York 14263
Buffalo, New York 14263
(716) 845-2300
Principal Investigator: Barbara J. Bambach
Phone: 800-767-9355
Roswell Park Cancer Institute Welcome to Roswell Park Cancer Institute (RPCI), America's first cancer center...
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1600 7th Avenue
Birmingham, Alabama 35233
Birmingham, Alabama 35233
(205) 638-9100
Principal Investigator: Matthew A. Kutny
Children's Hospital of Alabama Children
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700 Childrens Drive
Columbus, Ohio 43205
Columbus, Ohio 43205
(616) 722-2000
Principal Investigator: Mark A. Ranalli
Nationwide Children's Hospital At Nationwide Children’s, we are creating the future of pediatric health care....
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7777 Forest Ln # C840
Dallas, Texas 75230
Dallas, Texas 75230
(972) 566-7000
Principal Investigator: Stanton C. Goldman
Phone: 972-566-5588
Medical City Dallas Hospital If you have concerns for your health, that of a family...
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1500 E Duarte Rd
Duarte, California 91010
Duarte, California 91010
(626) 256-4673
Principal Investigator: Anna B. Pawlowska
Phone: 800-826-4673
City of Hope Comprehensive Cancer Center City of Hope is a leading research and treatment...
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2500 N State St
Jackson, Mississippi 39216
Jackson, Mississippi 39216
(601) 984-1000
Principal Investigator: Anderson (Andy) B. Collier
Phone: 601-815-6700
University of Mississippi Medical Center The University of Mississippi Medical Center, located in Jackson, is...
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747 52nd St
Oakland, California 94609
Oakland, California 94609
(510) 428-3000
Principal Investigator: Carla B. Golden
Children's Hospital and Research Center Oakland For nearly 100 years, Children's Hospital & Research Center...
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South 34th Street
Philadelphia, Pennsylvania 19104
Philadelphia, Pennsylvania 19104
215-590-1000
Principal Investigator: Jason L. Freedman
Children's Hospital of Philadelphia Since its start in 1855 as the nation's first hospital devoted...
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3181 Southwest Sam Jackson Park Road
Portland, Oregon 97239
Portland, Oregon 97239
503 494-8311
Principal Investigator: Bill H. Chang
Phone: 503-494-1080
Oregon Health and Science University In 1887, the inaugural class of the University of Oregon...
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60 Crittenden Blvd # 70
Rochester, New York 14642
Rochester, New York 14642
(585) 275-2121
Principal Investigator: Angela R. Girvin
Phone: 585-275-5830
University of Rochester The University of Rochester is one of the country's top-tier research universities....
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7700 Floyd Curl Dr
San Antonio, Texas 78229
San Antonio, Texas 78229
(210) 575-7000
Principal Investigator: Vinod K. Gidvani-Diaz
Methodist Children's Hospital of South Texas Methodist Children
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3020 Childrens way
San Diego, California 92123
San Diego, California 92123
(858) 576-1700
Principal Investigator: William D. Roberts
Rady Children's Hospital - San Diego Rady Children's Hospital-San Diego is the region’s pediatric medical...
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40 Sunshine Cottage Road
Valhalla, New York 10595
Valhalla, New York 10595
(914) 594-4000
Principal Investigator: Jessica C. Hochberg
Phone: 914-594-3794
New York Medical College The College was founded in 1860 by a group of New...
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1600 Rockland Road
Wilmington, Delaware 19803
Wilmington, Delaware 19803
(302) 651-4200
Principal Investigator: Scott M. Bradfield
Phone: 302-651-6884
Alfred I. duPont Hospital for Children Nemours began more than 70 years ago with the...
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1540 East Hospital Drive
Ann Arbor, Michigan 48109
Ann Arbor, Michigan 48109
(877) 475-6688
Principal Investigator: Rajen Mody
C S Mott Children's Hospital Behind the doors of C.S. Mott Children's Hospital there exist...
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13123 E 16th Ave
Aurora, Colorado 80045
Aurora, Colorado 80045
(720) 777-1234
Principal Investigator: Michael R. Verneris
Children's Hospital Colorado At Children's Hospital Colorado, we see more, treat more and heal more...
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401 North Broadway
Baltimore, Maryland 21287
Baltimore, Maryland 21287
410-955-5000
Principal Investigator: Orly R. Klein
Phone: 410-955-8804
Johns Hopkins University-Sidney Kimmel Cancer Center The name Johns Hopkins has become synonymous with excellence...
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Chapel Hill, North Carolina 27599
Principal Investigator: Stuart H. Gold
Phone: 877-668-0683
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1600 Southwest Archer Road
Gainesville, Florida 32610
Gainesville, Florida 32610
Principal Investigator: William B. Slayton
Phone: 352-273-8010
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30 Prospect Ave
Hackensack, New Jersey 07601
Hackensack, New Jersey 07601
(201) 996-2000
Principal Investigator: Jennifer A. Krajewski
Phone: 201-996-2879
Hackensack University Medical Center Hackensack University Medical Center, part of the Hackensack University Health Network,...
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705 Riley Hospital Dr
Indianapolis, Indiana 46202
Indianapolis, Indiana 46202
(317) 944-5000
Principal Investigator: Kamnesh R. Pradhan
Phone: 800-248-1199
Riley Hospital for Children Riley Hospital for Children at IU Health is a place of...
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Jacksonville, Florida 32207
Principal Investigator: Scott M. Bradfield
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Kansas City, Missouri 64108
Principal Investigator: Ibrahim A. Ahmed
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600 Highland Ave
Madison, Wisconsin 53792
Madison, Wisconsin 53792
(608) 263-6400
Principal Investigator: Kenneth B. De Santes
Phone: 800-622-8922
University of Wisconsin Hospital and Clinics UW Health strives to meet the health needs of...
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Nashville, Tennessee 37203
Principal Investigator: Haydar A. Frangoul
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New York, New York 10032
Principal Investigator: Alice Lee
Phone: 212-305-6361
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940 NE 13th St
Oklahoma City, Oklahoma 73190
Oklahoma City, Oklahoma 73190
(405) 271-6458
Principal Investigator: Rene Y. McNall-Knapp
Phone: 405-271-8777
University of Oklahoma Health Sciences Center The OU Health Sciences Center is composed of seven...
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Philadelphia, Pennsylvania 19104
Principal Investigator: Michael L. Nieder
Phone: 800-456-7121
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San Francisco, California 94158
Principal Investigator: Christopher C. Dvorak
Phone: 877-827-3222
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111 Michigan Ave NW
Washington, District of Columbia
Washington, District of Columbia
(202) 476-5000
Principal Investigator: Jeffrey S. Dome
Childrens National Medical Center As the nation’s children’s hospital, the mission of Children’s National Medical...
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