Phase 3 trials investigating PSC833 (valspodar) in AML
Study group . | Reference no. . | Diagnosis . | No. of patients . | Chemotherapy . | Outcome, P < .05 . |
|---|---|---|---|---|---|
| ECOG 2995 | Advani et al94 | Relapse or refractory | 127 | MEC (induction and consolidation) | Premature closure (no increase in CR) |
| CALGB 9720 | Baer et al96 | Age > 60 years | 120 | D-E-Ara-C (induction and consolidation) | Premature closure (toxicity) |
| HOVON, MRC (C302) | Sonneveld and List80 | Age > 60 years | 428 | DNR + Ara-C (induction) | Negative (RFS) |
| Novartis C301 | Sonneveld and List80 | Relapse or refractory | 256 | MEC (induction) | Negative (CR) |
| GOELAM | Solary et al88 | de novo AML age < 60 years | 425 | Ara-C + IDA (induction and consolidation); quinine | Increased CR (P-gp+) |
Study group . | Reference no. . | Diagnosis . | No. of patients . | Chemotherapy . | Outcome, P < .05 . |
|---|---|---|---|---|---|
| ECOG 2995 | Advani et al94 | Relapse or refractory | 127 | MEC (induction and consolidation) | Premature closure (no increase in CR) |
| CALGB 9720 | Baer et al96 | Age > 60 years | 120 | D-E-Ara-C (induction and consolidation) | Premature closure (toxicity) |
| HOVON, MRC (C302) | Sonneveld and List80 | Age > 60 years | 428 | DNR + Ara-C (induction) | Negative (RFS) |
| Novartis C301 | Sonneveld and List80 | Relapse or refractory | 256 | MEC (induction) | Negative (CR) |
| GOELAM | Solary et al88 | de novo AML age < 60 years | 425 | Ara-C + IDA (induction and consolidation); quinine | Increased CR (P-gp+) |
MEC indicates mitoxantrone (M), etoposide (E), cytarabine (Ara-C); D, daunorubicin; CR, complete remission rate; RFS, relapse-free survival; and IDA, idarubicin.