Reduced Intensity Conditioning for Hemophagocytic Syndromes or Selected Primary Immune Deficiencies (BMT CTN 1204)

PHASE2CompletedINTERVENTIONAL
Enrollment

47

Participants

Timeline

Start Date

December 31, 2013

Primary Completion Date

September 23, 2016

Study Completion Date

December 31, 2016

Conditions
Hemophagocytic LymphohistiocytosisChronic Active Epstein-Barr Virus InfectionChronic Granulomatous DiseaseHIGM-1Leukocyte Adhesion DeficiencyIPEX
Interventions
BIOLOGICAL

Hematopoietic Stem Cell Transplant

"NOTE: The - sign is the number of days before the transplant and the + sign is the number of days after the transplant.~* Alemtuzumab 0.2mg/kg Day-14,-13,-12,-11,-10~* Fludarabine 30 mg/m2 on Day -8,-7,-6,-5,-4~* Melphalan 140mg/m2 on Day -3~The GVHD prophylaxis will consist of the following:~* Cyclosporine on Day -3 to Day +100, maintaining a level of 250-500 ng/mL, then taper to Day +180.~* Methylprednisolone 2 mg/kg/day on Day -2 and -1, 1 mg/kg/day on Day 0 to Day +28, then taper over 1 month. Oral prednisone may be substituted starting on Day 0 (1.2 mg/kg/day)"

Trial Locations (22)

10065

Memorial Sloan-Kettering Cancer Center, New York

14642

University of Rochester Medical Center, Rochester

20010

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

21231

Johns Hopkins, Baltimore

27705

Duke University Medical Center, Durham

30322

Children's Healthcare of Atlanta, Atlanta

35294

University of Alabama at Birmingham, Birmingham

53211

Midwest Children's Cancer, Milwaukee

63110

Washington University/St. Louis Children's Hospital, St Louis

75235

Children's Medical Center of Dallas, Dallas

76104

Cook Children's Medical Center, Fort Worth

77030

Baylor College of Medicine, Houston

60614-3363

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

02215

Dana Farber Cancer Institute/Children's Hospital of Boston, Boston

48105-2967

University of Michigan Medical Center, Ann Arbor

27599-7305

University of North Carolina at Chapel Hill, Chapel Hill

45229-3039

Cincinnati Children's Hospital Medical Center, Cincinnati

97239-3098

Oregon Health and Science University, Portland

98109-1024

Fred Hutchinson Cancer Research Center, Seattle

V5Z 4E3

British Columbia Children's Hosp-Vancouver, Vancouver

H3T1C5

Hopital Sainte-Justine, Montreal

H4A 3J1

McGill University - Montreal, Montreal

All Listed Sponsors
collaborator

National Heart, Lung, and Blood Institute (NHLBI)

NIH

collaborator

Blood and Marrow Transplant Clinical Trials Network

NETWORK

collaborator

National Cancer Institute (NCI)

NIH

collaborator

National Marrow Donor Program

OTHER

lead

Medical College of Wisconsin

OTHER

NCT01998633 - Reduced Intensity Conditioning for Hemophagocytic Syndromes or Selected Primary Immune Deficiencies (BMT CTN 1204) | Biotech Hunter | Biotech Hunter