| Scemblix (asciminib) / Novartis |
ASC4INDIA, NCT06427811: Clinical Study of Asciminib in Previously Treated Indian Patients With Ph+ CML-CP Without T315I Mutation and in Patients With Ph+ CML-CP With T315I Mutation |
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| Not yet recruiting | 4 | 85 | NA | Asciminib, ABL001 | Novartis Pharmaceuticals | Philadelphia Chromosome-Positive Chronic Myeloid Leukemia in Chronic Phase | 04/25 | 04/25 | | |
| Active, not recruiting | 3 | 233 | Europe, Canada, Japan, US, RoW | Asciminib, ABL001, Bosutinib | Novartis Pharmaceuticals | Chronic Myelogenous Leukemia | 05/20 | 12/24 | | |
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2021-000678-27: A study to compare oral asciminib versus existing TKI medicines in patients with newly diagnosed CML Vizsgálat az orálisan alkalmazott asciminib és tirozin-kináz inhibitor (TKI) között újonnan diagnosztizált krónikus mieloid leukémiában (CML) szenvedő betegeknél |
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| Ongoing | 3 | 402 | Europe | Asciminib, Bosulif, Glivec, Tasigna, Sprycel, ABL001, STI571, AMN107, Film-coated tablet, Capsule, hard, Bosulif, Glivec, Tasigna, Sprycel | Novartis Pharma AG, Novartis Farmacéutica S.A., Novartis Pharma AG | Chronic Myelogenous Leukemia in chronic phase (CML-CP) in newly diagnosed patients, CML is a bone marrow cancer caused by a gene mutation which causes over growth of white blood cells., Diseases [C] - Cancer [C04] | | | | |
2020-006057-21: Asciminib treatment optimization in ≥ 3rd line CML-CP Optimización del tratamiento con asciminib en LMC-FC en >=3.ª línea |
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| Ongoing | 3 | 186 | Europe | Asciminib, ABL001, Film-coated tablet | Novartis Farmacéutica S.A., Novartis Pharma AG, Novartis Pharma AG | Chronic Myelogenous Leukemia in chronic phase (CML-CP) Leucemia mieloide crónica en fasecrónica (LMC-FC), CML is a bone marrow cancer caused by a gene mutation which causes over growth of white blood cells. LMC es un cáncer de médula ósea causado por mutación genética que causa un crecimiento excesivo de los glóbulos blancos., Diseases [C] - Cancer [C04] | | | | |
2022-000995-21: A study to compare asciminib versus nilotinib in patients with newly diagnosed CML |
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| Ongoing | 3 | 553 | Europe, RoW | Asciminib, Tasigna, ABL001, AMN107, Film-coated tablet, Capsule, hard, Tasigna | Novartis Pharma AG, NOVARTIS PHARMA AG, Novartis Pharma AG | Philadelphia Chromosome-Positive Chronic Myelogenous Leukemia in chronic phase (CML-CP) in newly diagnosed patients, CML is a bone marrow cancer caused by a gene mutation which causes over growth of white blood cells., Diseases [C] - Cancer [C04] | | | | |
AIM4CML, NCT04666259: Asciminib in Monotherapy for Chronic Myeloid Leukemia in Chronic Phase (CML-CP) With and Without T315I Mutation |
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| Completed | 3 | 56 | US | ABL001 | Novartis Pharmaceuticals | Chronic Myelogenous Leukemia - Chronic Phase | 06/23 | 06/24 | | |
| Active, not recruiting | 3 | 404 | Europe, Canada, Japan, US, RoW | Imatinib, STI571, Nilotinib, AMN107, Bosutinib, Dasatinib, Asciminib, ABL001 | Novartis Pharmaceuticals, Novartis Pharma AG | Chronic Myeloid Leukemia (CML) Philadelphia Chromosome Positive | 11/23 | 01/28 | | |
| Active, not recruiting | 3 | 199 | Europe, Canada, RoW | ABL001 40mg BID, asciminib, ABL001 80mg QD, ABL001 200mg QD | Novartis Pharmaceuticals, Novartis Pharma AG | Chronic Myelogenous Leukemia | 04/26 | 07/26 | | |
NCT05413915: Asciminib Used in Consolidation With Imatinib vs. Imatinib to Achieve TFR in CP-CML |
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| Recruiting | 3 | 164 | Canada | Asciminib, ABL-001, Imatinib, Imatinib mesylate | Sarit Assouline, Novartis | Chronic Myeloid Leukemia, Chronic Myeloid Leukemia, BCR/ABL-Positive, Chronic Myeloid Leukemia in Remission | 12/25 | 12/25 | | |
ASC4START, NCT05456191: A Study to Investigate Tolerability and Efficacy of Asciminib (Oral) Versus Nilotinib (Oral) in Adult Participants (≥18 Years of Age) With Newly Diagnosed Philadelphia Chromosome Positive Chronic Myelogenous Leukemia in Chronic Phase (Ph+ CML-CP) |
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| Active, not recruiting | 3 | 571 | Europe, Canada, US, RoW | Asciminib, ABL001, Nilotinib | Novartis Pharmaceuticals | Philadelphia Chromosome-Positive Chronic Myeloid Leukemia | 03/25 | 07/31 | | |
| Recruiting | 3 | 347 | Europe, Canada, Japan, US, RoW | Asciminib single agent, ABL001, Imatinib, STI571, Nilotinib, AMN107, Bosutinib, Dasatinib, Sprycel | Novartis Pharmaceuticals, Novartis Pharma AG | Chronic Myelogenous Leukemia, Leukemia, Myelogenous, Chronic, BCR-ABL Positive | 08/30 | 08/30 | | |
ACTRN12620000851965p: A study for patients with newly diagnosed Chronic Phase Myeloid Leukaemia evaluating the drug Asciminib. |
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| Not yet recruiting | 2 | 100 | | | Australiasian Leukaemia and Lymphoma Group, Novartis Pharmaceuticals Australia Pty Limited | Chronic Myeloid Leukaemia | | | | |
ACTRN12623001338651: CML14 (ASCENDANCE) - A study to assess efficacy of combination therapy with asciminib plus low dose dasatinib in newly diagnosed chronic phase Chronic Myeloid Leukaemia (CML) with high risk genetics |
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| Recruiting | 2 | 100 | | | Australasian Leukaemia and Lymphoma Group (ALLG), Australasian Leukaemia and Lymphoma Group (ALLG) | Chronic Myeloid Leukaemia (CML)
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| Not yet recruiting | 2 | 155 | Europe | Asciminib-Hydrochlorid, Nilotinib (Hydrochlorid-Monohydrat), Dasatinib (Monohydrat), Imatinib (Mesilat), ABL001, AMN107, Film-coated tablet, Capsule, hard, Tasigna, Sprycel, all Imatinib (Mesilat) proprietary medicinal products with a marketing authorisation in Germany can be used in this clinical trial, Scemblix | Friedrich-Schiller-Universität Jena, Novartis Pharma GmbH | Chronic Myeloid Leukemia, Chronic Myeloid Leukemia, Diseases [C] - Blood and lymphatic diseases [C15] | | | | |
| Active, not recruiting | 2 | 104 | Europe, Canada, US, RoW | Asciminib add-on, ABL001 (asciminib), Imatinib, STI571, Nilotinib, AMN107, Asciminib single agent | Novartis Pharmaceuticals | CML, Chronic Myelogenous Leukemia, Leukemia, Myeloid Chronic, Hematologic Diseases | 11/21 | 02/25 | | |
ACTRN12620000851965: A study for patients with newly diagnosed Chronic Phase Myeloid Leukaemia evaluating the drug Asciminib. |
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| Active, not recruiting | 2 | 100 | | | Australiasian Leukaemia and Lymphoma Group, Novartis Pharmaceuticals Australia Pty Limited | Chronic Myeloid Leukaemia | | | | |
NCT04795427: Study of Efficacy and Safety of CML-CP Patients Treated With Asciminib Versus Best Available Therapy, Previously Treated With 2 or More Tyrosine Kinase Inhibitors |
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| Active, not recruiting | 2 | 84 | RoW | asciminib, ABL001, best available treatment | Novartis Pharmaceuticals | Leukemia, Chronic Myelogenous | 05/23 | 12/24 | | |
NCT06236724: Phase II Study Assessing Efficacy and Safety of Asciminib in Patients With Newly Diagnosed Chronic Myeloid Leukemia in Chronic Phase. |
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| Recruiting | 2 | 50 | US | Asciminib, ABL001 | M.D. Anderson Cancer Center, Novartis Pharmaceuticals | Chronic Myeloid Leukemia | 07/33 | 07/35 | | |
NCT06308588: Phase II Study of the Combination of Blinatumomab and Asciminib in Patients With Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia |
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| Recruiting | 2 | 40 | US | Blinatumomab, Asciminib, ABL001 | M.D. Anderson Cancer Center, Novartis Pharmaceuticals | Philadelphia Chromosome-Positive, Acute Lymphoblastic Leukemia | 05/27 | 05/29 | | |
| Not yet recruiting | 2 | 69 | NA | Asciminib | Korean Society of Hematology | Chronic Myeloid Leukemia, Chronic Phase | 08/28 | 08/28 | | |
| Not yet recruiting | 2 | 160 | NA | Asciminib, Nilotinib | Gruppo Italiano Malattie EMatologiche dell'Adulto, Fundacion Espanola para la Curacion de la Leucemia Mieloide Cronica | CML, Chronic Phase, Chronic Myeloid Leukemia, Chronic Phase, Chronic Myeloid Leukemia, BCR/ABL-Positive, Chronic Myeloid Leukemia | 09/28 | 09/31 | | |
ASC4TARGET, NCT06514534: Open-label Study of Asciminib for CML-CP or CML-AP Patients With T315I Mutation Who Are Resistant, Intolerant or Ineligible to Ponatinib. |
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| Not yet recruiting | 2 | 20 | NA | ABL001/Asciminib | Novartis Pharmaceuticals | Chronic Myeloid Leukemia (CML) | 12/28 | 12/28 | | |
ALERTCML, NCT05143840: Asciminib as Initial Therapy for Patients With Chronic Myeloid Leukemia in Chronic Phase |
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| Recruiting | 2 | 8 | US | Asciminib, ABL001, Ascimininb + Nilotinib, ABL001 + TASIGNA, Asciminib + Imatinib, ABL001 + Gleevec, Asciminib + Dasatinib, ABL001 + Sprycel | Augusta University, H. Jean Khoury Cure CML Consortium | Chronic Myeloid Leukemia, Chronic Phase, Adult CML, Leukemia, Myeloid, Leukemia,Myeloid, Chronic | 02/25 | 02/27 | | |
| Active, not recruiting | 2 | 196 | US | asciminib, ABL001 | Novartis Pharmaceuticals | Chronic Myelogenous Leukemia - Chronic Phase | 09/25 | 10/27 | | |
NCT06773936: Adding Asciminib to Usual Treatment for Adults with Newly Diagnosed Philadelphia Chromosome Positive (Ph+) Acute Lymphoblastic Leukemia |
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| Not yet recruiting | 2 | 55 | NA | Induction Phase, Re-Induction Phase, Post-Remission, Maintenance | SWOG Cancer Research Network, Novartis Pharmaceuticals | Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia, CD19+ Acute Leukemia | 03/29 | 05/33 | | |
NCT06629584: Phase II Study of Asciminib for Second-line Treatment of Chronic Phase Chronic Myeloid Leukemia |
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| Not yet recruiting | 2 | 40 | US | Asciminib | M.D. Anderson Cancer Center, Novartis | Malignant Solid Tumors | 12/26 | 12/28 | | |
NCT04216563: ABL001 for the Treatment of Chronic Myeloid Leukemia in Patients Who Are on Therapy With Tyrosine Kinase Inhibitor |
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| Active, not recruiting | 2 | 40 | US | Asciminib, ABL001 | M.D. Anderson Cancer Center, National Cancer Institute (NCI) | Philadelphia Chromosome Negative, BCR-ABL1 Positive Chronic Myelogenous Leukemia | 12/25 | 12/25 | | |
| Active, not recruiting | 2 | 124 | Europe | Nilotinib, AMN107, Asciminib, ABL001 | Novartis Pharmaceuticals | Chronic Myeloid Leukemia | 11/26 | 12/26 | | |
| Active, not recruiting | 2 | 125 | Europe | Imatinib, Imatinib 400 mg QD and asciminib 60 mg QD, Nilotinib 300 mg, Nilotinib 300 mg BID and asciminib 20 mg BID or 40 mg QD, Dasatinib, Dasatinib 100 mg QD and asciminib 80 mg QD, Asciminib | University of Jena, Ludwig-Maximilians - University of Munich, Novartis Pharmaceuticals | Chronic Myeloid Leukemia | 12/27 | 12/27 | | |
NCT04838041: 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 |
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| Recruiting | 2 | 51 | US | Asciminib 40 MG, ABL001, Asciminib 40 MG Twice Daily, Asciminib 80 MG daily, Imatinib, Gleevec, Nilotinib, TASIGNA, Dasatinib, Sprycel | Medical College of Wisconsin, H. Jean Khoury Cure CML Consortium | Chronic Phase Chronic Myelogenous Leukemia | 06/28 | 07/29 | | |
2021-001286-20: Study to determine the dose and safety of asciminib in pediatric patients with chronic myeloid leukemia |
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| Ongoing | 1/2 | 40 | Europe | Asciminib, ABL001, Film-coated tablet | Novartis Pharma AG, NOVARTIS PHARMA AG, Novartis Pharma AG | Pediatric patients with Philadelphia chromosome positive chronic myeloid leukemia in chronic phase (Ph+ CML-CP), previously treated with one or more tyrosine kinase inhibitors, Cancer of the bone marrow, Diseases [C] - Cancer [C04] | | | | |
| Recruiting | 1/2 | 34 | Europe, Japan, US, RoW | Asciminib Pediatric formulation group, ABL001, Asciminib Adult formulation group | Novartis Pharmaceuticals, Novartis Pharma AG | Myeloid Leukemia, Philadelphia Positive | 06/26 | 11/31 | | |
| Completed | 1 | 326 | Europe, Japan, US, RoW | Asciminib (ABL001), ABL001, Nilotinib, Imatinib, Dasatinib | Novartis Pharmaceuticals | Chronic Myelogenous Leukemia, Philadelphia Chromosome-positive Acute Lymphoblastic Leukemia | 06/21 | 03/23 | | |
NCT03595917: ABL001 + Dasatinib + Prednisone + Blinatumomab in BCR-ABL+ B-ALL or CML |
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| Recruiting | 1 | 40 | US | ABL001, Dasatinib, Sprycel, Prednisone, Blinatumomab | Marlise Luskin, MD, Novartis | B-cell Acute Lymphoblastic Leukemia, Chronic Myeloid Leukemia (CML) in Lymphoid Blast Crisis, Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia Ph+ ALL | 11/25 | 11/26 | | |
NCT06211153: Real-world Effectiveness of Asciminib and Treatment Patterns in Patients With Chronic Myeloid Leukemia With T315I Mutation - a Chart Review Study of Patients Treated in the Asciminib Managed Access Program (MAP) |
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| Completed | N/A | 31 | Europe | | Novartis Pharmaceuticals | Chronic Myeloid Leukemia With T315I Mutation | 12/22 | 12/22 | | |
NCT06148493: Real-World Usage of Asciminib Among Patients With Chronic Myeloid Leukemia in Chronic Phase in the United States Using a Large Claims Database |
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| Completed | N/A | 425 | US | | Novartis Pharmaceuticals | Chronic Myeloid Leukemia | 12/22 | 12/22 | | |
NCT06516029: Real-World Evaluation of Patient Characteristics and Treatment Patterns Among Patients With CML-CP Treated With Asciminib |
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| Completed | N/A | 111 | US | | Novartis | Chronic Myeloid Leukemia, Chronic Phase | 10/23 | 10/23 | | |
| Available | N/A | | NA | Asciminib, ABL001 | Novartis Pharmaceuticals | Chronic Myeloid Leukemia in Chronic Phase | | | | |
NCT05421091: Special Drug Use-results Surveillance of Scemblix Tablets |
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| Completed | N/A | 550 | Japan | Asciminib | Novartis Pharmaceuticals | Chronic Myeloid Leukemia | 02/24 | 02/24 | | |
ASC4REAL, NCT06684964: RWE,NIS,Prospective Study for the Effectiveness, Tolerability and Adherence of Asciminib in Saudi Arabia. |
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| Not yet recruiting | N/A | 40 | NA | asciminib | Novartis Pharmaceuticals | Chronic Myelogenous Leukemia in Chronic Phase | 07/26 | 07/26 | | |
| Recruiting | N/A | 100 | RoW | Asciminib, Scemblix | Novartis Pharmaceuticals | Chronic Myeloid Leukemia | 07/25 | 07/25 | | |
ASSURE-3, NCT06092879: Asciminib Prospective Non Interventional Study as 3rd Line Therapy or More to Treat Adult Patients With CML- CP in Real World Setting in France |
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| Recruiting | N/A | 168 | Europe | Asciminib, Scemblix | Novartis Pharmaceuticals | Chronic Myeloid Leukemia | 12/26 | 12/26 | | |
