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Also known as Asciminib Adult formulation group
Asciminib Adult formulation · 1 trial · 3 indications
A dose-limiting toxicity (DLT) is defined as an adverse event which starts between Day 1 and Day 28, is suspected by the investigator to be related to asciminib, and meets one of the several criteria.
An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
Participants with Complete Response/Remission (CR) will achieve the following: No circulating blasts or extramedullary disease; No lymphadenopathy, splenomegaly, skin/gum infiltration, testicular mass/CNS involvement; Marrow \<5% blasts (M1) OR \< 1% blasts by flow cytometry. If a discrepancy occurs between disease detection methods, the result of the flow cytometry assay will be used to determine CR status; Peripheral blood count recovery; ANC \> 1000μL and platelets \> 100,000μL. CR evaluable: Participants will be considered CR evaluable for Part 2 if they have relapsed/refractory Ph+ ALL defined as either \>1% bone marrow (BM) blasts by MFC or immunoglobulin/T-cell receptor (IG/TCR) PCR, OR \> 5% BM blasts by morphologic evaluation at enrollment and are treated at RP2D.
| Arm | Type | Description |
|---|---|---|
| Single Arm | EXPERIMENTAL | Asciminib Adult formulation group: escalating doses evaluated Asciminib Pediatric formulation group: dose is based on body weight; dose level being evaluated will be converted into a mg/kg daily dose. For known T315I mutation: Fixed asciminib dose twice daily or the pediatric formulation dose equivalent twice daily. |
| Name | Type | Description |
|---|---|---|
| Asciminib Adult formulation | DRUG | oral, administered daily (twice daily for participants with known T315I mutation); Cycles 1, 2, 3 |
| Asciminib Pediatric formulation | DRUG | oral, administered daily (twice daily for participants with known T315I mutation); Cycles 1, 2, 3 |
| Dexamethasone | DRUG | Fixed doses, oral (preferred) or intravenous (IV) twice daily; Cycle 1, Days 1 - 14; (Cycle 1 = 28 days) |
| Vincristine | DRUG | Fixed doses, IV, weekly; Cycle 1 |
| Blinatumomab | DRUG | Dosing based on bone marrow disease burden and weight. Continuous IV infusion; Cycles 2, 3 |
| Methotrexate (intrathecal) | DRUG | Intrathecal |
| Cytarabine (intrathecal) | DRUG | Intrathecal |
| Hydrocortisone (intrathecal) | DRUG | Intrathecal |
| Prednisolone (intrathecal) | DRUG | Intrathecal |
Inclusion Criteria: * Evidence of Ph+ ALL or ABL1 or ABL2 fusion Ph-like ALL, inclusive of participants with ABL1 T315I mutation * Participants with CNS1, CNS2, CNS3a, or CNS3b at screening * Active B-Cell ALL at screening defined by MFC or IG/TCR PCR of ALL blasts \>0.01% in participants with eith...
Asciminib Adult formulation is an investigational small molecule being studied for the treatment of Acute Lymphoblastic Leukemia (ALL), specifically in pediatric and young adult patients with relapse/refractory Philadelphia positive (Ph+) or ABL-class Ph-like ALL. It is currently in Phase 1 clinical development.
Asciminib Adult formulation is a kinase inhibitor, belonging to the -nib class of drugs. It is being evaluated for its safety and efficacy in patients with Philadelphia positive or ABL-class Ph-like acute lymphoblastic leukemia, targeting the kinase pathways involved in these diseases.
Asciminib Adult formulation is being developed by Novartis AG, a multinational pharmaceutical company listed on the stock exchange under the ticker symbol NVS. The company is conducting clinical trials to evaluate the drug's safety and efficacy in acute lymphoblastic leukemia.
Asciminib Adult formulation is currently in Phase 1 clinical development. It is an investigational drug, meaning it has not yet been approved by regulatory authorities and is still undergoing clinical trials to assess its safety and efficacy in patients.
Asciminib Adult formulation is being studied in a Phase 1 clinical trial with the identifier NCT07387926. This trial is recruiting 50 participants and is evaluating the safety and efficacy of the drug in pediatric and young adult patients with relapse/refractory Philadelphia positive or ABL-class Ph-like acute lymphoblastic leukemia. The trial is being conducted in Israel.
Yes, Asciminib Adult formulation is also known as Asciminib Adult formulation group. These names refer to the same investigational drug being developed by Novartis AG for the treatment of acute lymphoblastic leukemia.