Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02688140 | Study for Patients With Newly Diagnosed, High-risk Acute Promyelocytic Leukemia | PHASE3 | COMPLETED | 135 | — | — | Jun 1, 2016 | Jan 20, 2025 | Feb 26, 2025 | 8 | France, Germany +3 |
events are: no achievement of haematological complete remission after induction therapy; no achievement of molecular remission after the last consolidation course; relapse; death including early death or development of secondary AML or MDS
| Arm | Type | Description |
|---|---|---|
| Arm A | EXPERIMENTAL | Induction therapy: Patients receive idarubicin i.v. over 20 minutes on day 1 and 3, oral tretinoin twice daily on day 1-28 (max. up to day 60) and arsenic trioxide i.v. over 2 hours on day 5-28 (max. up to day 60). In case of morphological CR and regenerated blood counts, consolidation therapy should be started within 2-4 weeks after documented CR. Consolidation therapy: Patients receive oral tretinoin twice daily on day 1-14. Treatment with tretinoin repeats every 4 weeks for up to 7 courses. Patients also receive arsenic trioxide i.v. over 2 hours on days 1-5 in week 1-4. Treatment with arsenic trioxide repeats every 8 weeks for up to 4 courses. |
| Arm B (standard chemotherapy) | ACTIVE_COMPARATOR | Induction therapy: Patients receive idarubicin i.v. over 20 minutes on day 1,3,5 and 7, oral tretinoin twice daily on day 1-28 (max. up to day 60). In case of morphological CR and regenerated blood counts, consolidation therapy should be started within 2-4 weeks after documented CR. Consolidation I: IDA 5 mg/m2 i.v. day 1-4 Ara-C 1000 mg/m2/3h i.v. day 1-4 ATRA 45 mg/m2 p.o. day 1-15 Consolidation II: MTZ 10 mg/m2 i.v. day 1-5 ATRA 45 mg/m2 p.o. day 1-15 Consolidation III: IDA 12 mg/m2 i.v. day 1 Ara-C 150 mg/m2 every 8h i.v. day 1-5 ATRA 45 mg/m2 p.o. day 1-15 Maintenance (duration 7 cycles = 2 years; one cycle lasts 106 days): 6-MP 50 mg/m2 p.o. Cycle 1-7: day 1-91 (followed by 15 days of ATRA on days 92-106) MTX 15mg/m2 i.m./p.o. Cycle 1-7: once weekly for 91 days (followed by 15 days of ATRA on days 92-106) ATRA 45 mg/m2 p.o. Cycle 1-6: day 92-106 Cycle 7: without ATRA Administration (treatment break of 6-MP and MTX during ATRA administration) |
| Name | Type | Description |
|---|---|---|
| Arsenic trioxide | DRUG | - |
| Idarubicin | DRUG | - |
| Cytarabine | DRUG | - |
| Tretinoin | DRUG | - |
| Mitoxantrone | DRUG | - |
| Mercaptopurine | DRUG | - |
| Methotrexate | DRUG | - |
Inclusion Criteria: * Informed consent * Women or men with a newly diagnosed APL by cytomorphology, confirmed by molecular analysis\* * Age ≥ 18 and ≤ 65 years * ECOG performance status 0-3 * WBC at diagnosis \> 10 GPt/l * Serum total bilirubin ≤ 3.0 mg/dl (≤ 51 µmol/l) * Serum creatinine ≤ 3.0 mg/...