Cytoxan, Fludara, and Antithymocyte Globulin Conditioning Followed By Stem Cell Transplant in Treating Fanconi Anemia

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

31

Participants

Timeline

Start Date

February 17, 2000

Primary Completion Date

October 10, 2020

Study Completion Date

October 10, 2020

Conditions
Fanconi Anemia
Interventions
BIOLOGICAL

Anti-Thymocyte Globulin

30 mg/kg/day will be administered after MP on days -6, -5, -4, -3 and -2.

DRUG

Cyclophosphamide

5 mg/kg is to be given as a 2 hour infusion, Days -6 through -3.

DRUG

Fludarabine

35 mg/m\^2 intravenously (IV) on days -6 through -2.

PROCEDURE

Hematopoietic Stem Cell Transplantation

Bone marrow or umbilical cord blood infusion on day 0.

DRUG

Methylprednisolone

Methylprednisolone (MP) 2 mg/kg/day intravenously every 24 hours will be given from day -6 until day -2 as a premedication for ATG.

DRUG

Filgrastim

5 mcg/kg per day intravenously (IV) continue until Absolute neutrophil count \> or = 2.5 x 10\^9/L

DRUG

Cyclosporine

Cyclosporine IV over 2 hours or orally every 8-12 hours beginning on day -3 and continuing until day 100, followed by a taper.

DRUG

Mycophenolate Mofetil

Day -3 through day +30 or for 7 days after engraftment, whichever day is later, if no acute GVHD. Engraftment is defined as 1st day of 3 consecutive days of absolute neutrophil count \[ANC\] \> 0.5 x 10\^9/L. MMF will be given at a dose of 15 mg/kg/dose every 8 hours PO (to a maximum dose of 1 gram).

Trial Locations (1)

55455

Masonic Cancer Center, University of Minnesota, Minneapolis

All Listed Sponsors
lead

Masonic Cancer Center, University of Minnesota

OTHER

NCT00630253 - Cytoxan, Fludara, and Antithymocyte Globulin Conditioning Followed By Stem Cell Transplant in Treating Fanconi Anemia | Biotech Hunter | Biotech Hunter