StudyFinder
MT2013-06C : Treatment of graft Failure after HSCT
Recruiting
The objectives of this study are to assess the following: - Incidence of sustained donor engraftment at day 42 post transplant - Incidence of transplant related mortality (TRM) at day 100 - Overall survival at day 100 and 1 year - Acute GVHD after this second transplant at day 100 and 6 months - Chronic GVHD after this second transplant at day 12 and 24 months
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.Clinics and Surgery Center (CSC)
Timothy Krepski - tkrepsk1@fairview.org
Troy Lund
1404M49341
15449
See this study on ClinicalTrials.gov