Therapy Detail
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| Therapy Name | Asciminib + Nilotinib |
| Synonyms | |
| Therapy Description | |
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| Drug Name | Trade Name | Synonyms | Drug Classes | Drug Description |
|---|---|---|---|---|
| Asciminib | Scemblix | ABL001|ABL-001 | BCR-ABL Inhibitor 32 | Scemblix (asciminib) is an allosteric inhibitor of BCR-ABL that binds to a unique location outside the ATP binding site, resulting in decreased BCR-ABL kinase activity and reduced tumor growth (PMID: 31543464, PMID: 31826340). Scemblix (asciminib) is FDA approved for use in patients with newly-diagnosed Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in chronic phase (CP), and in Ph+ CML patients in CP after two or more tyrosine kinase inhibitor treatments, and in adult patients with Ph+ CML in CP harboring ABL1 T315I (FDA.gov). |
| Nilotinib | Tasigna | AMN-107|AMN107 | ABL Inhibitor (pan) 9 BCR-ABL Inhibitor 32 CSF1R Inhibitor 28 DDR1 Inhibitor 10 DDR2 inhibitor 7 KIT Inhibitor 57 PDGFR Inhibitor (Pan) 30 | Tasigna (nilotinib) inhibits several tyrosine kinases including BCR-ABL, PDGFR, KIT, DDR and CSF-1R, potentially resulting in reduced tumor cell proliferation (PMID: 21419934, PMID: 25284748). Tasigna (nilotinib) is FDA approved for use in patients with Ph+ (BCR-ABL1) chronic myeloid leukemia (FDA.gov). |
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| Molecular Profile | Indication/Tumor Type | Response Type | Therapy Name | Approval Status | Evidence Type | Efficacy Evidence | References |
|---|
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| Clinical Trial | Phase | Therapies | Title | Recruitment Status | Covered Countries | Other Countries |
|---|---|---|---|---|---|---|
| NCT03906292 | Phase II | Asciminib + Nilotinib Asciminib + Imatinib Asciminib + Dasatinib | Frontline Asciminib Combination in Chronic Phase CML (CMLXI) | Active, not recruiting | DEU | 0 |
| NCT02081378 | Phase I | Asciminib Asciminib + Imatinib Asciminib + Dasatinib Asciminib + Nilotinib | A Phase I Study of Oral ABL001 in Patients With CML or Ph+ ALL | Completed | USA | NLD | ITA | FRA | ESP | DEU | AUS | 3 |
| NCT03874858 | Phase II | Nilotinib Asciminib + Nilotinib | De-escalation and TFR Study in CML Patients Treated With Nilotinib Followed by a Second Attempt After Nilotinib and Asciminib Combination (DANTE) | Active, not recruiting | ITA | 0 |
| NCT04838041 | Phase II | Asciminib + Imatinib Asciminib + Dasatinib Asciminib + Nilotinib | Protocol Number: HJKC3-0003. Treatment Free Remission After Combination Therapy With Asciminib (ABL001) Plus Tyrosine Kinase Inhibitors (TKI) in Chronic Phase Chronic Myeloid Leukemia (CP-CML) Patients Who Relapsed After a Prior Attempt at TKI Discontinuation | Recruiting | USA | 0 |
| NCT05143840 | Phase II | Asciminib Asciminib + Nilotinib | Asciminib as Initial Therapy for Patients With Chronic Myeloid Leukemia in Chronic Phase (ALERTCML) | Recruiting | USA | 0 |
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