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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04217278 | A Trial of Treatments to Assess the Effects on Outcome of Adults With AML and MDS Undergoing Allogeneic SCT | PHASE2 | ACTIVE NOT_RECRUITING | 333 | — | — | Jan 27, 2020 | May 1, 2026 | May 5, 2026 | 14 | United Kingdom |
Defined as time from entering the relevant randomisation to the relevant question until death from any cause. Patients who are alive at the end of the trial or have been lost to follow up will be censored at their date last seen. For randomisations 2 and 3 this outcome will also be calculated as time from transplantation in order to run a sensitivity analysis.
| Arm | Type | Description |
|---|---|---|
| R1: Intermediate dose Cytarabine | ACTIVE_COMPARATOR | First Randomisation (closed to recruitment) - control arm: Intermediate dose Cytarabine (1g/m\^2 administered by intravenous infusion over 2 hours on days 1-5 inclusive) |
| R1: Vyxeos | EXPERIMENTAL | First Randomisation (closed to recruitment) - experimental arm: Vyxeos (29mg/65mg/m\^2 administered by intravenous infusion over 90 minutes on days 1 and 3) |
| R2: FB4 | ACTIVE_COMPARATOR | Second Randomisation - under 55 years - control arm: Fludarabine (40mg/m\^2 days -7, -6, -5, and -4), Busulphan (3.2mg/kg days -7, -6, -5 and -4) |
| R2: TBF | EXPERIMENTAL | Second Randomisation - under 55 years - experimental arm: Thiotepa (5mg/kg day -7 and -6), Busulphan (3.2mg/kg days -5, -4 and -3), Fludarabine (50mg/m\^2 days -5, -4 and -3) |
| R3: FB2 | ACTIVE_COMPARATOR | Third Randomisation - 55 years and over (or under 55 with comorbidities) - control arm: Fludarabine (30mg/m\^2 days -6, -5, -4, -3 and -2), Busulphan (3.2mg/kg days -6 and -5) |
| Mini-TBF | EXPERIMENTAL | Third Randomisation - 55 years and over (or under 55 with comorbidities) - experimental arm: Thiotepa (5mg/kg day -6), Busulphan (3.2mg/kg days -5 and -4), Fludarabine (50mg/m\^2 days -5, -4, and -3) |
| Name | Type | Description |
|---|---|---|
| Vyxeos | DRUG | Vyxeos administered by intravenous infusion |
| Fludarabine | DRUG | Fludarabine administered by intravenous infusion |
| Busulphan | DRUG | Busulphan administered by intravenous infusion |
| Thiotepa | DRUG | Thiotepa administered by intravenous infusion |
| Cytarabine | DRUG | Cytarabine administered by intravenous infusion |
Eligibility Criteria for Randomisation 1 (closed to recruitment) Inclusion Criteria for Randomisation 1 1. Patients (≥ 18 years old) with a morphological documented diagnosis of AML or MDS who are deemed fit for allo-SCT with one of the following disease characteristics: AML * Patients in 1s...