Acute Myeloid Leukemia (AML)
Conditions
Brief summary
Proportion of elderly (≥60 - <75 years) patients with newly diagnosed AML eligible for allo-SCT treated with the “chemo-free” combination Venetoclax plus Decitabine (VEN-DEC) who get allo-SCT in CR/CRi/MLFS.
Detailed description
- Efficacy of VEN-DEC combination - Cumulative incidence of graft failure at +30 days, +100 days from transplant - Outcome of allo-SCT in term of NRM at day +100, 1 year and 2 years from allo-SCT - Cumulative incidence and severity of acute GvHD at 100 days after transplant - Cumulative incidence and severity of chronic GvHD at 1 and 2 years post transplant - RI at 1 and 2 year after transplantation from days of transplant. - OS at 1 and 2 years post transplant - DFS at 1 and 2 years post
Interventions
DRUGVenclyxto 100 mg film-coated tablets
Sponsors
Gruppo Italiano Per Il Trapianto Di Midollo Osseo Cellule Staminali Emopoietiche E Terapia Cellulare
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of elderly (≥60 - <75 years) patients with newly diagnosed AML eligible for allo-SCT treated with the “chemo-free” combination Venetoclax plus Decitabine (VEN-DEC) who get allo-SCT in CR/CRi/MLFS. | — |
Secondary
| Measure | Time frame |
|---|---|
| - Efficacy of VEN-DEC combination - Cumulative incidence of graft failure at +30 days, +100 days from transplant - Outcome of allo-SCT in term of NRM at day +100, 1 year and 2 years from allo-SCT - Cumulative incidence and severity of acute GvHD at 100 days after transplant - Cumulative incidence and severity of chronic GvHD at 1 and 2 years post transplant - RI at 1 and 2 year after transplantation from days of transplant. - OS at 1 and 2 years post transplant - DFS at 1 and 2 years post | — |
Countries
Italy
Outcome results
None listed