Stem Cell Transplant for Immunologic or Histiocytic Disorders

PHASE2CompletedINTERVENTIONAL
Enrollment

19

Participants

Timeline

Start Date

August 31, 2002

Primary Completion Date

August 31, 2012

Study Completion Date

August 31, 2014

Conditions
Hemophagocytic LymphohistiocytosisX-Linked Lymphoproliferative DisordersChediak-Higashi SyndromeGriscelli SyndromeImmunologic Deficiency SyndromesLangerhans-Cell Histiocytosis
Interventions
PROCEDURE

Stem Cell Transplant

IV on Day 0

DRUG

Fludarabine

30mg/m\^2 IV Day -7 through Day -3

DRUG

Melphalan

140 mg/m\^2 IV Day -1

DRUG

Anti-thymocyte globulin (ATG)

30 mg/kg IV Day -5 through Day -1

DRUG

Campath 1H

0.2 mg/kg IV X 5 days (used as an alternative to Anti-thymocyte globulin (ATG) if unable to tolerate ATG) Day -10 through Day -6

DRUG

Cyclosporin A

2.5 mg/kg IV every 12 hours (adults) or every 8 hours (children \<40 kg) maintaining a level of \>200mg/L Day -3 until Day +180 when, if no GVHD, the dose will be tapered 10% per week beginning on day 181

DRUG

Mycophenolate mofetil

15 mg/kg IV or orally bid and discontinued on Day +45 unless GVHD is present

DRUG

Intravenous immunoglobulin (IVIG)

500 mg/kg IV weekly beginning on Day +7 until Day +100

Trial Locations (1)

55455

Masonic Cancer Center University of Minnesota, Minneapolis

All Listed Sponsors
lead

Masonic Cancer Center, University of Minnesota

OTHER

NCT00176865 - Stem Cell Transplant for Immunologic or Histiocytic Disorders | Biotech Hunter | Biotech Hunter