Lactobacillus Plantarum in Preventing Acute Graft Versus Host Disease in Children Undergoing Donor Stem Cell Transplant

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

173

Participants

Timeline

Start Date

April 30, 2018

Primary Completion Date

June 30, 2022

Study Completion Date

June 30, 2026

Conditions
Acute Graft Versus Host DiseaseHematopoietic and Lymphatic System NeoplasmLeukemiaLymphoma
Interventions
PROCEDURE

Allogeneic Hematopoietic Stem Cell Transplantation

Undergo alloHCT

BIOLOGICAL

Lactobacillus plantarum strain 299

Given PO or via NJ, NG or G tube

BIOLOGICAL

Lactobacillus plantarum strain 299v

Given PO or via NJ, NG or G tube

OTHER

Placebo Administration

Given PO or via NJ, NG or G tube

Trial Locations (43)

10032

NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center, New York

10595

New York Medical College, Valhalla

14263

Roswell Park Cancer Institute, Buffalo

14642

University of Rochester, Rochester

19104

Children's Hospital of Philadelphia, Philadelphia

19803

Alfred I duPont Hospital for Children, Wilmington

20010

Children's National Medical Center, Washington D.C.

21287

Johns Hopkins University/Sidney Kimmel Cancer Center, Baltimore

27599

UNC Lineberger Comprehensive Cancer Center, Chapel Hill

32207

Nemours Children's Clinic-Jacksonville, Jacksonville

32610

University of Florida Health Science Center - Gainesville, Gainesville

32827

Nemours Children's Hospital, Orlando

33701

Johns Hopkins All Children's Hospital, St. Petersburg

35233

Children's Hospital of Alabama, Birmingham

37203

The Children's Hospital at TriStar Centennial, Nashville

37232

Vanderbilt University/Ingram Cancer Center, Nashville

39216

University of Mississippi Medical Center, Jackson

43205

Nationwide Children's Hospital, Columbus

44195

Cleveland Clinic Foundation, Cleveland

46202

Riley Hospital for Children, Indianapolis

48109

C S Mott Children's Hospital, Ann Arbor

49503

Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital, Grand Rapids

53792

University of Wisconsin Carbone Cancer Center - University Hospital, Madison

64108

Children's Mercy Hospitals and Clinics, Kansas City

70118

Children's Hospital New Orleans, New Orleans

73104

University of Oklahoma Health Sciences Center, Oklahoma City

75230

Medical City Dallas Hospital, Dallas

78207

Children's Hospital of San Antonio, San Antonio

78229

Methodist Children's Hospital of South Texas, San Antonio

80045

Children's Hospital Colorado, Aurora

90027

Children's Hospital Los Angeles, Los Angeles

91010

City of Hope Comprehensive Cancer Center, Duarte

92123

Rady Children's Hospital - San Diego, San Diego

94158

UCSF Medical Center-Mission Bay, San Francisco

94609

UCSF Benioff Children's Hospital Oakland, Oakland

96826

Kapiolani Medical Center for Women and Children, Honolulu

97239

Oregon Health and Science University, Portland

06520

Yale University, New Haven

02215

Dana-Farber Cancer Institute, Boston

07601

Hackensack University Medical Center, Hackensack

T3B 6A8

Alberta Children's Hospital, Calgary

M5G 1X8

Hospital for Sick Children, Toronto

H3T 1C5

Centre Hospitalier Universitaire Sainte-Justine, Montreal

All Listed Sponsors
collaborator

National Cancer Institute (NCI)

NIH

lead

Children's Oncology Group

NETWORK