Cytoxan, Fludara, and Antithymocyte Globulin Conditioning Followed By Stem Cell Transplant in Treating Fanconi Anemia | Aplastic Anemia & MDS International Foundation
Cytoxan, Fludara, and Antithymocyte Globulin Conditioning Followed By Stem Cell Transplant in Treating Fanconi Anemia

Clinical Trial: NCT00630253

For more details on this clinical trial, including contact information, please see this trial’s listing on clinicaltrials.gov:
Purpose: 

OBJECTIVES:

Primary

Secondary

  • To evaluate the incidence of acute graft-versus-host disease (GVHD) and chronic GVHD in patients treated with this regimen.
  • To evaluate the incidence of regimen-related toxicity in these patients.
  • To evaluate the 1-year survival of patients treated with this regimen.
  • To evaluate the incidence of late secondary malignancies (e.g., squamous cell carcinoma of the head and neck or cervix) in patients treated with this regimen.

OUTLINE:

  • Preparative cytoreductive therapy: Patients receive cyclophosphamide IV over 2 hours on days -6 to -3 and fludarabine phosphate IV over 30 minutes and anti-thymocyte globulin IV over 4-6 hours on days -6 to -2.
  • T-cell depleted donor hematopoietic stem cell transplantation: Patients undergo T-cell depleted donor bone marrow or umbilical cord blood stem cell transplantation on day 0. Patients also receive filgrastim (G-CSF) IV beginning on day 1 and continuing until blood counts recover.
  • Graft-versus-host disease prophylaxis: Patients receive cyclosporine IV over 2 hours or orally every 8-12 hours beginning on day -3 and continuing until day 100, followed by a taper. Patients will receive Mycophenolate Mofetil (MMF) therapy beginning on 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.

After completion of study therapy, patients are followed periodically.

Status: 
Recruiting
Study Date: 
Fri, 03/05/2010 to Wed, 06/01/2016
Intervention: 
Biological: anti-thymocyte globulin 30 mg/kg/day will be administered after MP on days -6, - 5, -4, -3 and -2. Other Name: ATGAM Drug: cyclophosphamide 5 mg/kg is to be given as a 2 hour infusion, Days -6 through -3. Other Name: Cytoxan Drug: fludarabine phosphate 35 mg/m^2 intravenously (IV) on days -6 through -2. Other Name: Fludara Procedure: hematopoietic stem cell transplantation Bone marrow or umbilical cord blood infusion on day 0. Other Name: stem cell transplant Drug: methylprednisolone MP 2 mg/kg/day intravenously every 24 hours will be given from day -6 until day +15 at which time it will be tapered 50% every 4 days to be discontinued by day +24 (i.e. MP 1 mg/kg/day on days +16-19, then 0.5 mg/kg/day on days +20-23, then discontinue). MP will be used as a premedication for ATG on day -6 to -2. Other Name: MP Drug: filgrastim Initiate G-CSF 5 mcg/kg per day intravenously (IV) continue until Absolute neutrophil count > or = 2.5 x 10^9/L Other Name: G-CSF 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 Other Name: CSA Drug: Mycophenolate Mofetil Patients will receive Mycophenolate Mofetil (MMF) therapy beginning on 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). Other Name: MMF