LCH-IV, International Collaborative Treatment Protocol for Children and Adolescents With Langerhans Cell Histiocytosis

PHASE2/PHASE3RecruitingINTERVENTIONAL
Enrollment

1,400

Participants

Timeline

Start Date

November 2, 2016

Primary Completion Date

July 31, 2026

Study Completion Date

July 31, 2026

Conditions
Langerhans Cell Histiocytosis
Interventions
DRUG

Prednisone

Stratum I

DRUG

Vinblastine

Stratum I

DRUG

mercaptopurine

Stratum I

DRUG

INDOMETHACIN

Indomethacin fixed dose given daily orally in two divided doses with gastric protection for total treatment duration of 24 months.

DRUG

Methotrexate

fixed dose weekly orally for total treatment duration of 24 months.

DRUG

Cytosine Arabinoside

DRUG

2-chlorodeoxyadenosine

PROCEDURE

hematopoietic stem cell transplantation (RIC-HSCT)

BIOLOGICAL

Intravenous immunoglobulin

Trial Locations (42)

10029

RECRUITING

Mount Sinai Hospital, New York

10032

RECRUITING

Columbia University / Herbert Irving Cancer Center, New York

10170

RECRUITING

Memorial Sloan Kettering Cancer Center, New York

10467

RECRUITING

Children's Hospital at Montefiore, The Bronx

11040

RECRUITING

Cohen Children's Medical Center, New Hyde Park

13210

RECRUITING

SUNY Upstate Medical University, Syracuse

15224

RECRUITING

UPMC Children's Hospital of Pittsburgh, Pittsburgh

20010

RECRUITING

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

21287

RECRUITING

Johns Hopkins University, Baltimore

28203

RECRUITING

Carolinas Medical Center, Levine Children's Hospital, Charlotte

29425

RECRUITING

Medical University of South Carolina (MUSC), Charleston

29605

RECRUITING

Greenville Health System BI-LO Charities Children's Cancer Center, Greenville

30342

RECRUITING

Children's Healthcare of Atlanta, Emory, Atlanta

33701

RECRUITING

Johns Hopkins All Children's Hospital, St. Petersburg

35233

RECRUITING

Children's of Alabama, Birmingham

37232

NOT_YET_RECRUITING

Vanderbilt-Ingram Cancer Center, Nashville

38105

RECRUITING

St. Jude Children's Research Hospital, Memphis

40202

RECRUITING

University of Louisville, Norton Children's Hospital, Louisville

40536

COMPLETED

University of Kentucky A.B.Chandler Medical Center, Lexington

43606

RECRUITING

Russell J Ebeid Children's Hospital (Promedica), Toledo

44106

RECRUITING

Rainbow Babies & Children's Hospital, University Hospitals, Cleveland

44308

RECRUITING

Akron Children's Hospital, Akron

45229

COMPLETED

Cincinnati Children's Hospital Medical Center, Cincinnati

46202

NOT_YET_RECRUITING

Riley Hospital for Children - Indiana University, Indianapolis

53792

RECRUITING

American Family Children's Hospital University of Wisconsin, Madison

55404

NOT_YET_RECRUITING

Children's Minnesota, Minneapolis

64108

RECRUITING

Children's Mercy Hospitals, Kansas City

72202

RECRUITING

Arkansas Children's Hospital, Little Rock

75235

RECRUITING

Children's Medical Center Dallas, UT Southwestern, Dallas

85006

RECRUITING

Phoenix Children's Hospital, Phoenix

90027

NOT_YET_RECRUITING

Children's Hospital of Los Angeles, Los Angeles

92868

RECRUITING

Children's Hospital of Orange County, Orange

93636

RECRUITING

Valley Children's Healthcare, Madera

94609

COMPLETED

UCSF Benioff Children's Hospital of Oakland, Oakland

98431

RECRUITING

Madigan Army Medical Center, Tacoma

99204

RECRUITING

Providence Sacred Heart Children's Hospital, Spokane

94158-0106

RECRUITING

UCSF Helen Diller Family Cancer Center, San Francisco

06106

RECRUITING

Connecticut Children's Medical Center, Hartford

60611-2991

RECRUITING

Ann & Robert H. Lurie Children's Hospital of Chicago, Chicago

02114

RECRUITING

Massachusetts General Hospital, Boston

02115

RECRUITING

Dana Farber Cancer Institute, Boston

07601

RECRUITING

Hackensack University Medical Center, Hackensack

All Listed Sponsors
collaborator

Histiocyte Society

OTHER

lead

North American Consortium for Histiocytosis

OTHER