Eligibility criteria of phase 2 and 3 trials of oral decitabine/cedazuridine
| Characteristic . | Phase 2 (NCT02103478) . | Phase 3 (NCT03306264) . |
|---|---|---|
| Study population | MDS (IPSS low, intermediate-1, intermediate-2, or high risk) and CMML | US: MDS (IPSS intermediate-1, intermediate-2, or high-risk) and CMML; Europe: de novo or secondary AML not candidates for intensive therapy |
| Performance status | ECOG 0-2 | ECOG 0-1 |
| Previous HMA | <2 cycles | <2 cycles |
| Previous allogeneic SCT | Yes; no GVHD and off immunosuppression | Yes; no GVHD and off immunosuppression |
| Hematologic function | None specified | WBC <15 × 109 /L |
| Renal function | Serum creatinine ≤1.5× ULN or >50 mL/min per 1.73 m2 | Serum creatinine ≤1.5× ULN or >50 mL/min per 1.73 m2 |
| Hepatic function | AST/ALT ≤2.5× ULN | AST/ALT ≤2.5× ULN |
| Bilirubin ≤2× ULN | Bilirubin ≤2× ULN |
| Characteristic . | Phase 2 (NCT02103478) . | Phase 3 (NCT03306264) . |
|---|---|---|
| Study population | MDS (IPSS low, intermediate-1, intermediate-2, or high risk) and CMML | US: MDS (IPSS intermediate-1, intermediate-2, or high-risk) and CMML; Europe: de novo or secondary AML not candidates for intensive therapy |
| Performance status | ECOG 0-2 | ECOG 0-1 |
| Previous HMA | <2 cycles | <2 cycles |
| Previous allogeneic SCT | Yes; no GVHD and off immunosuppression | Yes; no GVHD and off immunosuppression |
| Hematologic function | None specified | WBC <15 × 109 /L |
| Renal function | Serum creatinine ≤1.5× ULN or >50 mL/min per 1.73 m2 | Serum creatinine ≤1.5× ULN or >50 mL/min per 1.73 m2 |
| Hepatic function | AST/ALT ≤2.5× ULN | AST/ALT ≤2.5× ULN |
| Bilirubin ≤2× ULN | Bilirubin ≤2× ULN |
ALT, alanine aminotransferase; AST, aspartate aminotransferase; GVHD, graft-versus-host disease; SCT, stem cell transplant; ULN, upper limit of normal.