Tacrolimus and Methotrexate With or Without Sirolimus in Preventing Graft-Versus-Host Disease in Young Patients Undergoing Donor Stem Cell Transplant for Acute Lymphoblastic Leukemia in Complete Remission

PHASE3CompletedINTERVENTIONAL
Enrollment

146

Participants

Timeline

Start Date

March 31, 2007

Primary Completion Date

May 31, 2011

Study Completion Date

June 30, 2017

Conditions
B-cell Childhood Acute Lymphoblastic LeukemiaChildhood Acute Lymphoblastic Leukemia in RemissionGraft Versus Host DiseaseL1 Childhood Acute Lymphoblastic LeukemiaL2 Childhood Acute Lymphoblastic LeukemiaT-cell Childhood Acute Lymphoblastic Leukemia
Interventions
DRUG

thiotepa

Given IV

DRUG

cyclophosphamide

Given IV

DRUG

tacrolimus

Given IV or orally

DRUG

methotrexate

Given IV

DRUG

sirolimus

Given orally

RADIATION

total body irradiation

Part of the transplant preparatory regimen

Trial Locations (50)

4029

Royal Brisbane and Women's Hospital, Herston

6008

Princess Margaret Hospital for Children, Perth

10032

Columbia University Medical Center, New York

10595

New York Medical College, Valhalla

14263

Roswell Park Cancer Institute, Buffalo

14642

University of Rochester, Rochester

15224

Children's Hospital of Pittsburgh of UPMC, Pittsburgh

17033

Penn State Hershey Children's Hospital, Hershey

19104

Children's Hospital of Philadelphia, Philadelphia

20010

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

23298

Virginia Commonwealth University, Richmond

27599

University of North Carolina, Chapel Hill

29425

Medical University of South Carolina, Charleston

30322

Children's Healthcare of Atlanta - Egleston, Atlanta

33701

All Children's Hospital, St. Petersburg

37232

Vanderbilt-Ingram Cancer Center, Nashville

40202

Kosair Children's Hospital, Louisville

43205

Nationwide Children's Hospital, Columbus

44106

Rainbow Babies and Childrens Hospital, Cleveland

44195

Cleveland Clinic Foundation, Cleveland

45229

Cincinnati Children's Hospital Medical Center, Cincinnati

46202

Indiana University Medical Center, Indianapolis

48109

C S Mott Children's Hospital, Ann Arbor

48202

Wayne State University, Detroit

52242

University of Iowa Hospitals and Clinics, Iowa City

53226

Midwest Children's Cancer Center, Milwaukee

53792

University of Wisconsin Hospital and Clinics, Madison

60614

Childrens Memorial Hospital, Chicago

63110

Washington University School of Medicine, St Louis

64108

The Childrens Mercy Hospital, Kansas City

70118

Children's Hospital-Main Campus, New Orleans

75390

University of Texas Southwestern Medical Center, Dallas

76104

Cook Children's Medical Center, Fort Worth

78229

Methodist Children's Hospital of South Texas, San Antonio

80045

Children's Hospital Colorado, Aurora

84113

Primary Children's Medical Center, Salt Lake City

85016

Phoenix Childrens Hospital, Phoenix

91010

City of Hope Medical Center, Duarte

92123

Rady Children's Hospital - San Diego, San Diego

94143

University of California San Francisco Medical Center-Parnassus, San Francisco

97239

Oregon Health and Science University, Portland

98105

Seattle Children's Hospital, Seattle

94609-1809

Children's Hospital and Research Center at Oakland, Oakland

92868-3874

Childrens Hospital of Orange County, Orange

21287-8936

Johns Hopkins University, Baltimore

07601

Hackensack University Medical Center, Hackensack

V6H 3V4

British Columbia Children's Hospital, Vancouver

R3E 0V9

CancerCare Manitoba, Winnipeg

M5G 1X8

Hospital for Sick Children, Toronto

H3H 1P3

The Montreal Children's Hospital of the MUHC, Montreal

All Listed Sponsors
collaborator

National Cancer Institute (NCI)

NIH

lead

Children's Oncology Group

NETWORK

NCT00382109 - Tacrolimus and Methotrexate With or Without Sirolimus in Preventing Graft-Versus-Host Disease in Young Patients Undergoing Donor Stem Cell Transplant for Acute Lymphoblastic Leukemia in Complete Remission | Biotech Hunter | Biotech Hunter