Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Omitted Doxorubicin · 1 trial · 1 indication
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 ...
Omitted Doxorubicin is an investigational small molecule being studied for the treatment of acute lymphoblastic leukemia. It is currently in Phase 3 clinical development. The drug is being evaluated in a large, randomized, biomarker-selected trial enrolling patients aged 0 to 45 years with this condition.
Omitted Doxorubicin is being developed by Amgen Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol AMGN. The drug is currently in Phase 3 clinical development for acute lymphoblastic leukemia.
Omitted Doxorubicin is in Phase 3 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The ongoing Phase 3 trial is actively recruiting participants with acute lymphoblastic leukemia.
Omitted Doxorubicin is being studied in one active Phase 3 clinical trial, NCT04307576. This trial is a randomized, biomarker-selected study enrolling approximately 6,430 participants aged 0 to 45 years with acute lymphoblastic leukemia. The trial is recruiting in multiple European countries.
The specific molecular target of Omitted Doxorubicin has not been disclosed in available information. The drug is being studied in a biomarker-selected patient population, indicating that patient selection is based on specific biological markers, though the exact target is not specified.