Dasatinib in imatinib-resistant Philadelphia chromosome-positive leukemias
Phase 1NCT00064233
- Population
- Patients with various phases of CML or with Ph-positive ALL who could not tolerate or were resistant to imatinib
- Design
- Phase 1 dose-escalation study; dasatinib 15 to 240 mg per day was given orally in four-week treatment cycles, once or twice daily.
- Arms
- Dasatinib (dose escalation) (experimental): Dasatinib orally, 15 to 240 mg per day, once or twice daily
- People
- Talpaz M, senior author Sawyers CL
Show the numbers
| Endpoint | Analysis | Dasatinib (dose escalation) | Control | Effect |
|---|---|---|---|---|
| MCyRChronic-phase CML cohort (a complete hematologic response occurred in 37 of 40 patients) | primaryTalpaz 2006 | 45% | — | The abstract reports the major cytogenetic response rates 'in these two phases' as 45 percent and 25 percent, respectively, after naming chronic phase first; denominators are not given. |
| MCyRAccelerated-phase CML, CML with blast crisis, or Ph-positive ALL (major hematologic responses in 31 of 44 patients) | primaryTalpaz 2006 | 25% | — | Nearly all patients with lymphoid blast crisis or Ph-positive ALL relapsed within six months. Responses occurred across BCR-ABL genotypes except T315I. |
| Endpoint | Analysis | Dasatinib (dose escalation) | Control | Effect |
|---|---|---|---|---|
| MCyRChronic-phase CML cohort (a complete hematologic response occurred in 37 of 40 patients) | primaryTalpaz 2006 | 45% | — | The abstract reports the major cytogenetic response rates 'in these two phases' as 45 percent and 25 percent, respectively, after naming chronic phase first; denominators are not given. |
| MCyRAccelerated-phase CML, CML with blast crisis, or Ph-positive ALL (major hematologic responses in 31 of 44 patients) | primaryTalpaz 2006 | 25% | — | Nearly all patients with lymphoid blast crisis or Ph-positive ALL relapsed within six months. Responses occurred across BCR-ABL genotypes except T315I. |