Stem Cell Transplant (SCT) for Dyskeratosis Congenita or SAA

PHASE2/PHASE3CompletedINTERVENTIONAL
Enrollment

36

Participants

Timeline

Start Date

August 31, 2007

Primary Completion Date

March 31, 2015

Study Completion Date

June 30, 2016

Conditions
Dyskeratosis CongenitaAplastic Anemia
Interventions
DRUG

Campath 1H

10, 9, 8, 7, and 6 days before transplant subjects will be given 1 dose of campath 1H given via catheter (0.2 mg/kg over 2 hours).

DRUG

Cyclophosphamide

7 days before the transplant, 1 dose of cyclophosphamide is given via catheter (50mg/kg IV over 2 hours).

DRUG

Fludarabine

6, 5, 4, 3, and 2 days before the transplant, 1 dose fludarabine is given via catheter (40 mg/kg IV over 1 hour)

PROCEDURE

Total Body Irradiation

1 day before the transplant one dose (200 cGy) of total body irradiation is given

PROCEDURE

Stem Cell Transplantation

Infusion of stem cells on Day 0.

DRUG

antithymocyte globulin

ATG (rabbit) 3 mg/kg for 3 days.

DRUG

Methylprednisolone

2mg/kg IV is given before each dose of antithymocyte globulin (ATG).

Trial Locations (1)

55455

Masonic Cancer Center, University of Minnesota, Minneapolis

All Listed Sponsors
lead

Masonic Cancer Center, University of Minnesota

OTHER

NCT00455312 - Stem Cell Transplant (SCT) for Dyskeratosis Congenita or SAA | Biotech Hunter | Biotech Hunter