Vinblastine/Prednisone Versus Single Therapy With Cytarabine for Langerhans Cell Histiocytosis (LCH)

PHASE3RecruitingINTERVENTIONAL
Enrollment

124

Participants

Timeline

Start Date

March 7, 2016

Primary Completion Date

January 31, 2027

Study Completion Date

January 31, 2029

Conditions
Langerhans Cell Histiocytosis
Interventions
DRUG

Cytarabine

Cytarabine 100 mg/m\^2/day IV for five consecutive days. This five-day cycle will be repeated every 21 days for a total of four cycles for all patients regardless of response. Each new cycle may not begin until absolute neutrophil count (ANC) is ≥ 750/mcL and platelet count is ≥ 75,000/mcL.

DRUG

Vinblastine/prednisone

"Vinblastine/Prednisone +/- 6-mercaptopurine based on risk category. Patients with high-risk organ involvement (liver, spleen, hematopoeitic system) will receive 6-mercaptopurine during Continuation Therapy as this is the current standard of care treatment.~Vinblastine 6 mg/m\^2/dose IV push weekly for patients ≥ 12 months of age. Vinblastine will be dosed at 3 mg/m\^2/dose for patients under 6 months of age, and dosed at 4.5 mg/m\^2/dose for patients 6 months of age to 11.99 months of age.~Prednisone (or prednisolone) 20 mg/m2/dose by mouth twice a day"

Trial Locations (11)

18103

RECRUITING

Lehigh Valley Health Network- Cedar Crest, Allentown

23507

RECRUITING

Children's Hospital of The King's Daughters, Norfolk

43205

RECRUITING

Nationwide Children's Hospital, Columbus

55455

WITHDRAWN

University of Minnesota/Masonic Cancer Center, Minneapolis

76104

RECRUITING

Cook Children's Health Care System, Fort Worth

77030

RECRUITING

Texas Children's Hospital, Houston

78207

RECRUITING

Children's Hospital of San Antonio, San Antonio

78503

RECRUITING

Vannie Cook Children's Clinic, McAllen

78723

RECRUITING

Dell Children's Medical Center, Austin

92123

RECRUITING

Rady Children's Hospital - San Diego, San Diego

94304

RECRUITING

Stanford Children's Hospital, Lucile Packard Children's Hospital, Palo Alto

All Listed Sponsors
lead

Baylor College of Medicine

OTHER