MT2013-06C : Treatment of graft Failure after HSCT
Inclusion Criteria:Patients with primary or secondary graft failure, as defined below, may receive a second transplant: Primary graft failure is defined as not achieving an ANC ≥0.5x10^9/L for three consecutive days by day 35 - 42 following the first transplant. Secondary graft failure is defined as achieving an ANC ≥0.5x10^9/L for three consecutive days by day 35 - 42, but subsequently drops below 0.5x10^9/L without recovery. Loss of chimerism is defined as achieving an ANC ≥0.5x10^9/L for three consecutive, but with less than 10% CD15+ donor cells in the marrow or peripheral blood. Recipients should have acceptable organ function defined as: Renal: creatinine < 2.0 (adults) and creatinine clearance > 30. For creatinine clearance < 70, consultation with a BMT pharmacist is necessary for chemotherapy dose adjustments. Hepatic: bilirubin, AST/ALT, ALP < 10 x upper limit of normal Cardiac: left ventricular ejection fraction > 40%
Exclusion Criteria:Uncontrolled infection at the time of transplant. Patients with Fanconi Anemia or other DNA breakage syndromes.
Drug: Cyclophosphamide, Drug: Fludarabine, Biological: Hematopoietic stem cell infusion, Radiation: Total Body Irradiation
Primary Graft Failure, Secondary Graft Failure
Clinics and Surgery Center (CSC)
Timothy Krepski - email@example.com
1404M49341See this study on ClinicalTrials.gov