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MT2013-06C : Treatment of graft Failure after HSCT

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This study is NOT accepting healthy volunteers
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: Fludarabine, Drug: Cyclophosphamide, Radiation: Total Body Irradiation, Biological: Hematopoietic stem cell infusion

Primary Graft Failure, Secondary Graft Failure

Hematopoietic stem cell transplant, Clinics and Surgery Center (CSC)

Timothy Krepski - tkrepsk1@fairview.org
Troy Lund
N/A
1404M49341
NCT02161783
See this study on ClinicalTrials.gov

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