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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04307576 | A Treatment Study Protocol for Participants 0-45 Years With Acute Lymphoblastic Leukaemia | PHASE3 | RECRUITING | 6,430 | — | — | Jul 13, 2020 | Jun 1, 2033 | May 5, 2026 | 138 | Belgium, Denmark +13 |
The primary endpoint for the whole protocol (compared with the legacy protocols of the participating study-groups forming the consortium) is event-free survival (EFS) - as defined in the protocol.
The primary endpoint for the TKI intervention is event-free survival (EFS) - as defined in the protocol, from the start of TKI until event or end of follow-up
The primary endpoint for Randomisation 1 and 2 is disease-free survival (DFS) - as defined in the protocol counting from the time of randomisation
The primary endpoint for Randomisation 3 and the ABL-class fusion intervention is disease-free survival (DFS) - as defined in the protocol counting from the time of randomisation (R3) and the start of TKI-therapy (ABL-class fusion intervention).
Fraction of patients with undetectable MRD ("Complete MRD response") at the end of one cycle of Blinatumomab (+/- 1 week)
| Arm | Type | Description |
|---|---|---|
| R1 - SR standard arm | NO_INTERVENTION | Standard risk arm receiving standard treatment (Delayed Intensification including Doxorubicin). |
| R1 - SR experimental arm | EXPERIMENTAL | Standard risk arm, receiving Delayed Intensification without Doxorubicin IV 3 x 30 mg/m2/dose. |
| R2 - IR-low standard arm | NO_INTERVENTION | Standard treatment with Delayed Intensification including Doxorubicin and Maintenance including Vincristine+Dexamethasone pulses. |
| R2 - IR-low experimental arm A | EXPERIMENTAL | Standard treatment with omission of Doxorubicin IV 3 x 30 mg/m2/dose in the Delayed Intensification phase. |
| R3 - IR-high standard arm | NO_INTERVENTION | Intermediate risk high arm receiving Standard Maintenance Therapy. |
| R3-InO - IR-high experimental arm | EXPERIMENTAL | Inotuzumab IV 0,5 mg/m2, given on days 253, 260, 267 and on days 274, 281, 288 before start of Standard Maintenance Therapy. |
| ABL-class fusions intervention | EXPERIMENTAL | Imatinib p.o. 340 mg/m2 given daily from day 15 or 30 (depending on age) to the end of therapy (week 106) in addition to Standard IR-high chemotherapy. |
| R3-TEAM - IR-high experimental arm | EXPERIMENTAL | 6-tioguanine p.o, 2,5-12,5 mg/m2, given daily in addition to Standard Maintenance Therapy. |
| ALLTogether1 DS Blinatumomab intervention | EXPERIMENTAL | Blinatumomab IV, 5 mcg/m2/day up to 28 mcg/day (detailed dosing in protocol) continous infusion. Two 28 day courses with a two week treatment free interval in between. Blinatumomab courses replace Consolidation 1 and Consolidation 2 in the standard protocol adapted for Down syndrome patients. |
| R2 - IR-low experimental arm B | EXPERIMENTAL | Standard treatment with omission of monthly pulses of Vincristine IV 1,5 mg/m2/dose and 5 days of Dexamethasone p.o. 6 mg/m2/day in the Maintenance Phase. |
| Name | Type | Description |
|---|---|---|
| Omitted Doxorubicin | DRUG | Omission of IV Doxorubicin |
| Omitted Vincristine+Dexamethasone pulses | DRUG | Omission of Vincristine+Dexamethasone pulses |
| Inotuzumab Ozogamicin+Standard Maintenance Therapy | DRUG | Addition of IV Inotuzumab ozogamicin before Maintenance Therapy |
| Imatinib | DRUG | p.o. Imatinib |
| 6-tioguanine+Standard Maintenance Therapy | DRUG | Addition of p.o. 6-tioguanine to Standard Maintenance Therapy |
| Blinatumomab | DRUG | IV Blinatumomab |
Inclusion Criteria: * Patients newly diagnosed with T-lymphoblastic (T-cell) or B-lymphoblastic precursor (BCP) leukaemia (ALL) according to the WHO-classification of Tumours of Haematopoetic and Lymphoid Tissues (Revised 4th edition 2017) and with a diagnosis confirmed by an accredited laboratory ...