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Efficacy/Safety of CPI-613 in Combination With HD Cyt. and Mito. vs HD Cyt. and Mito. in Older Patients With R/R AML
A Phase III study to evaluate the safety and efficacy of CPI-613® (devimistat) in combination with High Dose Cytarabine and Mitoxantrone in comparison with high dose Cytarabine and Mitoxantrone and control sub-groups: combination of Mitoxantrone, Etoposide and Cytarabine (MEC) and combination of Fludarabine, Cytarabine, and Filgrastim (FLAG) in older patients with relapsed/refractory Acute Myeloid Leukemia. CPI-613® (devimistat) targets the altered energy metabolism and processes for production of ATP and essential bio-intermediates unique to and characteristic of most cancer cell types. The addition of CPI-613® (devimistat) to high dose cytarabine and mitoxantrone (CHAM) will improve the complete remission (CR) rate in patients 50 years or older with relapsed or refractory AML when compared to HAM alone or other control sub groups.
Details
| Lead sponsor | Cornerstone Pharmaceuticals |
|---|---|
| Phase | PHASE3 |
| Status | TERMINATED |
| Enrolment | 200 |
| Start date | Mon Nov 12 2018 00:00:00 GMT+0000 (Coordinated Universal Time) |
| Completion | Wed Jan 19 2022 00:00:00 GMT+0000 (Coordinated Universal Time) |
Conditions
- Relapsed/Refractory Acute Myeloid Leukemia
Interventions
- CPI-613 + High Dose Cytarabine and Mitoxantrone
- High Dose Cytarabine and Mitoxantrone
- Mitoxantrone, Etoposide and Cytarabine
- Fludarabine, Cytarabine, Filgrastim
Countries
France, Belgium, Austria, Germany, Poland, South Korea, Australia, United States, Spain