Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
A+ Epratuzumab · 1 trial · 1 indication
SR induction/consolidation ALL-REZ BFM 2002 versus UK-ALL-R3 (randomisation 1): 10% pEFS superiority of arm B above a 65% pEFS at 4 years of arm A
SR consolidation +/- epratuzumab (randomisation 2): 10% pEFS superiority of the arm with epratuzumab above an expected 74% pEFS at 4 years of the standard arm
| Arm | Type | Description |
|---|---|---|
| SR-A | NO_INTERVENTION | Patients randomized to the SR-A Arm receive induction, consolidation and maintenance therapy according to a modified protocol ALL-REZ BFM 2002 with Protocol II-IDA as 1st consolidation element. In this arm patients are randomized not to receive epratuzumab.This randomization has been stopped pre-term on 1.2.2019 since the investigational product is not provided anymore by the manufacturer. |
| SR-A + Epratuzumab | ACTIVE_COMPARATOR | Patients randomized to the SR-A Arm receive induction, consolidation and maintenance therapy according to a modified protocol ALL-REZ BFM 2002 with Protocol II-IDA as 1st consolidation element. In this arm patients are randomized to receive epratuzumab. This randomization has been stopped pre-term on 1.2.2019 since the investigational product is not provided anymore by the manufacturer. |
| SR-B | NO_INTERVENTION | Patients randomized to the SR-B Arm receive induction, post-induction and maintenance therapy according to the protocol ALL-R3. In this arm patients are randomized not to receive epratuzumab. This randomization has been stopped pre-term on 1.2.2019 since the investigational product is not provided anymore by the manufacturer. |
| SR-B + Epratuzumab | ACTIVE_COMPARATOR | Patients randomized to the SR-B Arm receive induction, post-induction and maintenance therapy according to the protocol ALL-R3. In this arm patients are randomized to receive epratuzumab. This randomization has been stopped pre-term on 1.2.2019 since the investigational product is not provided anymore by the manufacturer. |
| Name | Type | Description |
|---|---|---|
| SR-A + Epratuzumab | DRUG | - |
| SR-B + Epratuzumab | DRUG | - |
Inclusion Criteria: * Morphologically confirmed diagnosis of 1st relapsed precursor B-cell or T-cell ALL * Children less than 18 years of age at inclusion * Meeting SR criteria: late isolated or late/early combined B-cell precursor (BCP) bone marrow (BM) relapse, any late/early isolated extramedull...
A+ Epratuzumab is an investigational small molecule being studied for the treatment of Acute Lymphoblastic Leukemia (ALL). It is currently in Phase 3 clinical development, though the single Phase 3 trial evaluating it has been completed.
A+ Epratuzumab is being developed by Pulmonx Corporation, a company traded on the NASDAQ under the ticker symbol LUNG. The drug is in Phase 3 clinical development for Acute Lymphoblastic Leukemia (ALL).
A+ Epratuzumab is in Phase 3 clinical development. The Phase 3 trial, NCT01802814, has been completed. The drug remains investigational and has not been approved by regulatory authorities.
A+ Epratuzumab has one completed Phase 3 clinical trial, NCT01802814, titled "International Study for Treatment of Standard Risk Childhood Relapsed ALL 2010." The trial enrolled 700 participants with Acute Lymphoblastic Leukemia (ALL) across multiple countries including Australia, Austria, Belgium, Czechia, Denmark, Finland, France, Germany, Israel, Italy, Japan, Netherlands, Norway, Poland, Portugal, Switzerland, and the United Kingdom.
A+ Epratuzumab is a combination regimen that includes epratuzumab, an investigational drug being studied for Acute Lymphoblastic Leukemia (ALL). The Phase 3 trial NCT01802814 evaluates this combination in pediatric patients with relapsed ALL.