Table 1.
Trials | Azacitadine alone NCT00422890 |
Cellular adoptive immunotherapy NCT00107354 |
Decitabine plus second SCT NCT00002832 |
DLI plus Dendritic Cells NCT00476177 |
Azacitadine plus DLI NCT00795548 |
---|---|---|---|---|---|
Inclusion Criteria | Age>18 Chimerism <80% without hematologic relapse (<5% BM blasts) |
Age>14 KPS 60–100% MRD |
Age<60 ECOG PS 0–2 Relapsed within 12 months |
Age≥18 ECOG PS 0–2 >2months since HSCT |
Age>18 ECOG PS 0–2 Eligible for DLI |
Exclusion Criteria | Uncontrolled infection Active HBV or HIV AST or ALT >3× normal CrCl<50ml/min WBC <3,000 Platelets <75,000 |
aGVHD grade III or IV cGVHD |
Uncontrolled infection aGVHD grade >2 Any cGVHD Cr >2mg/dl Bilirubin >3mg/dl EF <40% CNS disease |
Uncontrolled infection aGVHD grade II–IV Extensive cGVHD Prior DLI within 8 weeks On IS for <2 weeks prior to enrollment |
Uncontrolled infection Active HBV or HCV Bilirubin > 1.5 xULN GFR <50ml/min Childs Pugh B or C Severe CV disease CNS disease Treatment with other investigational agents after relapse |
KPS – Karnofsky performance status. ECOG PS – Eastern Cooperative Group Performance Status. HSCT – Hematopoietic Stem Cell Transplant. DLI – Donor Lymphocyte Infusion. GVHD – graft versus host disease. Cr – Creatinine. CrCl – Creatinine Clearance. EF – Ejection Fraction. CNS – central nervous system. IS – Immuno suppressions.