Hematopoietic Stem Cell Transplantation in High Risk Patients With Fanconi Anemia

PHASE2CompletedINTERVENTIONAL
Enrollment

14

Participants

Timeline

Start Date

March 26, 2002

Primary Completion Date

October 10, 2020

Study Completion Date

October 10, 2020

Conditions
Fanconi Anemia
Interventions
BIOLOGICAL

anti-thymocyte globulin

Given 15 mg/kg/day intravenously every 12 hours on Days -5 through -1.

BIOLOGICAL

filgrastim

given 5 mcg/kg/day intravenously on Day 1 (continue until absolute neutrophil count (ANC) ≥2.5 x 10\^9/L)

DRUG

busulfan

Busulfan 0.8 mg/kg intravenously (IV) every 12 hours on Days -7 and -6 (1.0 mg/kg IV if \<4 years old)

DRUG

cyclophosphamide

10 mg/kg intravenously (IV) on Days -5 through -2.

DRUG

fludarabine phosphate

35 mg/m\^2 intravenously (IV) on Days -5 through -2.

DRUG

methylprednisolone

1 mg/kg intravenously (IV) every 12 hours on Days -5 through -1.

BIOLOGICAL

Hematopoietic stem cell transplantation

Infused on Day 0 - Donor bone marrow or umbilical cord blood will be collected in the usual sterile manner using established parameters determined by the National Marrow Donor Program.

Trial Locations (1)

55455

Masonic Cancer Center, University of Minnesota, Minneapolis

All Listed Sponsors
lead

Masonic Cancer Center, University of Minnesota

OTHER

NCT00258427 - Hematopoietic Stem Cell Transplantation in High Risk Patients With Fanconi Anemia | Biotech Hunter | Biotech Hunter