Asciminib Roll-over undersøgelse
Et åbent etiket, multicenter Asciminib Roll-over-undersøgelse til vurdering af langsigtet sikkerhed hos patienter, der har gennemført en Novartis-sponsoreret asciminib-undersøgelse og er vurderet af investigator til at drage fordel af fortsat behandling
This is a long term safety study for patients who have completed a Novartis sponsored asciminib study and are judged by the investigator to benefit from continued treatment
Studieoversigt
Status
Detaljeret beskrivelse
This is an open-label, multi-center, global roll-over study designed to assess long term safety and provide continued treatment to participants who have previously participated in an asciminib Novartis sponsored study and who, in the opinion of the investigator, would benefit from continued treatment as in their parent study but are unable to access this treatment outside of the clinical study.
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Fase 4
Udvidet adgang
Kontakter og lokationer
Studiekontakt
- Navn: Novartis Pharmaceuticals
- Telefonnummer: 1-888-669-6682
- E-mail: novartis.email@novartis.com
Undersøgelse Kontakt Backup
- Navn: Novartis Pharmaceuticals
- Telefonnummer: +41613241111
Studiesteder
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Capital Federal, Argentina, C1114AAN
- Rekruttering
- Novartis Investigative Site
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Buenos Aires
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CABA, Buenos Aires, Argentina, C1221ADC
- Rekruttering
- Novartis Investigative Site
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Rio de Janeiro
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Rio de Janeiro, Rio de Janeiro, Brasilien, 20211-030
- Afsluttet
- Novartis Investigative Site
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São Paulo
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São Paulo, São Paulo, Brasilien, 08270-070
- Afsluttet
- Novartis Investigative Site
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São Paulo, São Paulo, Brasilien, 05403-000
- Afsluttet
- Novartis Investigative Site
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Varna, Bulgarien, 9000
- Rekruttering
- Novartis Investigative Site
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Quebec
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Montreal, Quebec, Canada, H1T 2M4
- Rekruttering
- Novartis Investigative Site
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Copenhagen, Danmark, 2100
- Afsluttet
- Novartis Investigative Site
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London, Det Forenede Kongerige, W12 0HS
- Rekruttering
- Novartis Investigative Site
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Oxford, Det Forenede Kongerige, OX3 7LE
- Rekruttering
- Novartis Investigative Site
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Michigan
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Ann Arbor, Michigan, Forenede Stater, 48109-5271
- Rekruttering
- Michigan Med University of Michigan
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Ledende efterforsker:
- Moshe Talpaz
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Kontakt:
- Kelly Whitley
- E-mail: kwhitley@med.umich.edu
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Missouri
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St Louis, Missouri, Forenede Stater, 63110
- Rekruttering
- Washington University School Of Medicine-Siteman Cancer Ctr
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Ledende efterforsker:
- Iskra Pusic
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Kontakt:
- Morgan Swanner
- Telefonnummer: 314-236-8866
- E-mail: swanner@wustl.edu
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New York
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New York, New York, Forenede Stater, 10017
- Rekruttering
- Memorial Sloan Kettering
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Ledende efterforsker:
- Michael Mauro
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Kontakt:
- Shakira Pascual
- Telefonnummer: 646-497-9068
- E-mail: pascuals@mskcc.org
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Ohio
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Cincinnati, Ohio, Forenede Stater, 45242
- Rekruttering
- Oncology Hematology Care Inc
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Ledende efterforsker:
- David Waterhouse
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Oregon
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Portland, Oregon, Forenede Stater, 97239
- Aktiv, ikke rekrutterende
- Oregon Health Sciences University
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Texas
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Dallas, Texas, Forenede Stater, 75251
- Rekruttering
- Texas Oncology
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Ledende efterforsker:
- Moshe Yair Levy
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Kontakt:
- Jessica Maner
- Telefonnummer: +1 214 370 1000
- E-mail: Jessica.Maner@usoncology.com
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Houston, Texas, Forenede Stater, 77030
- Rekruttering
- Uni Of TX MD Anderson Cancer Cntr
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Kontakt:
- Susan Aline Wahl
- Telefonnummer: +1 713 792 2921
- E-mail: sawahl2@mdanderson.org
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Ledende efterforsker:
- Fadi Haddad
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Utah
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Salt Lake City, Utah, Forenede Stater, 84112
- Rekruttering
- Huntsman Cancer Institute
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Ledende efterforsker:
- Srinivas Tantravahi
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Kontakt:
- Aneesh Pappireddy
- Telefonnummer: 801-585-3453
- E-mail: Aneesh.Pappireddy@hci.utah.edu
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Wisconsin
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Milwaukee, Wisconsin, Forenede Stater, 53226
- Rekruttering
- Medical College of Wisconsin
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Ledende efterforsker:
- Ehab Atallah
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Kontakt:
- Esta Konkol
- Telefonnummer: 414-805-6803
- E-mail: ekonkol@mcw.edu
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Bordeaux, Frankrig, 33076
- Rekruttering
- Novartis Investigative Site
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Lyon, Frankrig, 69373
- Rekruttering
- Novartis Investigative Site
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Marseille, Frankrig, 13273
- Rekruttering
- Novartis Investigative Site
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Nantes, Frankrig, 44093
- Rekruttering
- Novartis Investigative Site
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Paris, Frankrig, 75475
- Rekruttering
- Novartis Investigative Site
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Vandœuvre-lès-Nancy, Frankrig, 54511
- Rekruttering
- Novartis Investigative Site
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Naples, Italien, 80131
- Afsluttet
- Novartis Investigative Site
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MI
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Milan, MI, Italien, 20162
- Rekruttering
- Novartis Investigative Site
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RM
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Roma, RM, Italien, 00161
- Rekruttering
- Novartis Investigative Site
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Hyōgo
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Kobe, Hyōgo, Japan, 6500017
- Aktiv, ikke rekrutterende
- Novartis Investigative Site
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Beijing, Kina, 100730
- Rekruttering
- Novartis Investigative Site
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Beijing, Kina, 100044
- Aktiv, ikke rekrutterende
- Novartis Investigative Site
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Shanghai, Kina, 200025
- Aktiv, ikke rekrutterende
- Novartis Investigative Site
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Shenyang, Kina, 110004
- Rekruttering
- Novartis Investigative Site
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Tianjin, Kina, 300020
- Rekruttering
- Novartis Investigative Site
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Chongqing Municipality
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Chongqing, Chongqing Municipality, Kina, 400010
- Rekruttering
- Novartis Investigative Site
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Guangdong
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Guangzhou, Guangdong, Kina, 510515
- Rekruttering
- Novartis Investigative Site
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Henan
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Zhengzhou, Henan, Kina, 450008
- Rekruttering
- Novartis Investigative Site
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Hubei
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Wuhan, Hubei, Kina, 430022
- Rekruttering
- Novartis Investigative Site
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Jilin
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Changchun, Jilin, Kina, 130021
- Rekruttering
- Novartis Investigative Site
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Shanxi
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Xian, Shanxi, Kina, 710004
- Rekruttering
- Novartis Investigative Site
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Sichuan
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Chengdu, Sichuan, Kina, 610041
- Afsluttet
- Novartis Investigative Site
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Beirut, Libanon, 113-0236
- Afsluttet
- Novartis Investigative Site
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Johor Bahru, Malaysia, 80100
- Rekruttering
- Novartis Investigative Site
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Kuala Selangor, Malaysia, 68000
- Rekruttering
- Novartis Investigative Site
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Pulau Pinang
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George Town, Pulau Pinang, Malaysia, 10450
- Rekruttering
- Novartis Investigative Site
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Nuevo León
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Monterrey, Nuevo León, Mexico, 64460
- Rekruttering
- Novartis Investigative Site
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Khoudh, Oman, 123
- Rekruttering
- Novartis Investigative Site
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Katowice, Polen, 40-519
- Rekruttering
- Novartis Investigative Site
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Krakow, Polen, 30-688
- Afsluttet
- Novartis Investigative Site
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Warsaw, Polen, 00-791
- Rekruttering
- Novartis Investigative Site
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Wroclaw, Polen, 50-367
- Afsluttet
- Novartis Investigative Site
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Lisbon, Portugal, 1099-023
- Aktiv, ikke rekrutterende
- Novartis Investigative Site
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Porto, Portugal, 4200-072
- Rekruttering
- Novartis Investigative Site
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Timișoara, Rumænien, 300079
- Afsluttet
- Novartis Investigative Site
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Moscow, Rusland, 125284
- Aktiv, ikke rekrutterende
- Novartis Investigative Site
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Moscow, Rusland, 125167
- Aktiv, ikke rekrutterende
- Novartis Investigative Site
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Saint Petersburg, Rusland, 191024
- Rekruttering
- Novartis Investigative Site
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Saint Petersburg, Rusland, 197341
- Rekruttering
- Novartis Investigative Site
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Riyadh, Saudi Arabien, 11211
- Afsluttet
- Novartis Investigative Site
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Singapore, Singapore, 169608
- Aktiv, ikke rekrutterende
- Novartis Investigative Site
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Barcelona, Spanien, 08035
- Rekruttering
- Novartis Investigative Site
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Barcelona, Spanien, 08036
- Afsluttet
- Novartis Investigative Site
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Madrid, Spanien, 28041
- Afsluttet
- Novartis Investigative Site
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Madrid, Spanien, 28006
- Rekruttering
- Novartis Investigative Site
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Madrid, Spanien, 28034
- Afsluttet
- Novartis Investigative Site
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Seville, Spanien, 41009
- Rekruttering
- Novartis Investigative Site
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Valencia, Spanien, 46026
- Rekruttering
- Novartis Investigative Site
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A Coruna
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Santiago Compostela, A Coruna, Spanien, 15706
- Rekruttering
- Novartis Investigative Site
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Barcelona
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Badalona, Barcelona, Spanien, 08916
- Rekruttering
- Novartis Investigative Site
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L'Hospitalet de Llobregat, Barcelona, Spanien, 08907
- Afsluttet
- Novartis Investigative Site
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Bizkaia
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Bilbao, Bizkaia, Spanien, 48013
- Rekruttering
- Novartis Investigative Site
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Santa Cruz De Tenerife
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Santa Cruz, Santa Cruz De Tenerife, Spanien, 38009
- Rekruttering
- Novartis Investigative Site
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Busan, Sydkorea, 49201
- Afsluttet
- Novartis Investigative Site
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Jeollanam, Sydkorea, 519763
- Afsluttet
- Novartis Investigative Site
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Seoul, Sydkorea, 03080
- Rekruttering
- Novartis Investigative Site
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Gyeonggi-do
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Uijeongbu-si, Gyeonggi-do, Sydkorea, 11759
- Aktiv, ikke rekrutterende
- Novartis Investigative Site
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Taoyuan, Taiwan, 33305
- Aktiv, ikke rekrutterende
- Novartis Investigative Site
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Brno, Tjekkiet, 625 00
- Rekruttering
- Novartis Investigative Site
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Poruba
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Ostrava, Poruba, Tjekkiet, 708 52
- Rekruttering
- Novartis Investigative Site
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Atakum
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Samsun, Atakum, Tyrkiet (Türkiye), 55200
- Rekruttering
- Novartis Investigative Site
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Berlin, Tyskland, 13353
- Rekruttering
- Novartis Investigative Site
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Kiel, Tyskland, 24116
- Rekruttering
- Novartis Investigative Site
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Hesse
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Frankfurt am Main, Hesse, Tyskland, 60590
- Rekruttering
- Novartis Investigative Site
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Thuringia
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Jena, Thuringia, Tyskland, 07740
- Rekruttering
- Novartis Investigative Site
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Hanoi, Vietnam, 100000
- Rekruttering
- Novartis Investigative Site
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Ho Chi Minh City, Vietnam, 70000
- Rekruttering
- Novartis Investigative Site
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Graz, Østrig, 8036
- Rekruttering
- Novartis Investigative Site
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Vienna, Østrig, 1140
- Rekruttering
- Novartis Investigative Site
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Key Inclusion Criteria:
- Participant with PH+ CML or PH+ ALL currently receiving treatment with asciminib (single agent or in combination with imatinib, nilotinib or dasatinib), imatinib, nilotinib or bosutinib alone within a Novartis-sponsored study and, in the opinion of the Investigator, would benefit from continued treatment.
- Participant has demonstrated compliance on the parent study protocol and is willing and able to comply with scheduled visits, treatment plans and any other study procedures.
Key Exclusion Criteria:
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Participant has been discontinued from parent study treatment.
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Participant currently has unresolved toxicities reported as possibly related to study treatment in the parent study.
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Participant's ongoing treatment is currently approved and reimbursed at country level.
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Pregnant or nursing (lactating) women.
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Women of child-bearing potential, unless they are using highly effective methods of contraception and willing to continue while taking study treatment.
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Sexually active males receiving imatinib, nilotinib, bosutinib or dasatinib unwilling to follow the relevant contraception requirements in the local prescribing information.
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Applicable for participants on bosutinib treatment at the end of the CABL001A2301 and on other TKIs for CABL001A2202 study that switch to asciminib treatment:
- Asymptomatic (grade 2) pancreatitis if not resolved within 28 days
- QTcF>480msec or inability to determine QTc interval
- any grade 3 or 4 toxicity not resolved to grade 2 or lower within 28 days before starting asciminib treatment
Other protocol-defined Inclusion/Exclusion criteria may apply.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Ikke-randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Asciminib single agent group
Participants with CML or ALL, from Novartis sponsored asciminib studies, including but not limited to CABL001A2301, CABL001A2302, CABL001X2101, CABL001A2202, CABL001AUS04 and CABL001AUS08 studies, that were receiving asciminib |
Taken orally, twice daily (BID) or once daily (QD), in fasting state
Andre navne:
|
|
Andet: Bosutinib single agent group
Participants with CML-CP, from Novartis sponsored asciminib study CABL001A2301, that were receiving bosutinib |
Taken orally, once daily, with food |
|
Eksperimentel: Bosutinib-Asciminib switch group
Participants with CML-CP, from Novartis sponsored asciminib study CABL001A2301 that were receiving bosutinib treatment and switched to asciminib when entering this study or during the course of this study |
Taken orally, twice daily (BID) or once daily (QD), in fasting state
Andre navne:
|
|
Eksperimentel: Asciminib in combination with imatinib group
Participants with CML from Novartis sponsored asciminib studies CABL001E2201 or CABL001X2101 that were receiving asciminib combined with imatinib |
Taken orally, once daily, in the morning with low-fat meal
Andre navne:
|
|
Eksperimentel: Asciminib in combination with nilotinib group
Participants with CML or ALL from Novartis sponsored asciminib studies CABL001E2201or CABL001X2101 that were receiving asciminib combined with nilotinib |
Taken orally, twice daily, on an empty stomach
Andre navne:
|
|
Andet: Imatinib single agent group
Participants with CML-CP, from Novartis sponsored asciminib study CABL001E2201 that were receiving imatinib |
Taken orally, once daily, in the morning with low-fat meal
Andre navne:
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Andet: Nilotinib single agent group
Participants with CML-CP, from Novartis sponsored asciminib study CABL001E2201 and CABL001J12302 that were receiving nilotinib |
Taken orally, twice daily, on an empty stomach
Andre navne:
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Eksperimentel: Asciminib in combination with dasatinib group
Participants with CML from Novartis sponsored study CABL001X2101 that were receiving asciminib with dasatinib |
Taken orally, once daily in a fasted state, 1 or 2 hours before a meal
Andre navne:
|
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Andet: Dasatinib single agent group
Participant with CML-CP , from Novartis sponsored asciminib study CABL001A2202, CABL001J12301, that were receiving Dasatinib. |
Taken orally, once daily in a fasted state, 1 or 2 hours before a meal
Andre navne:
|
|
Eksperimentel: Dasatinib-Asciminib switch group
Participants with CML-CP, from Novartis sponsored asciminib study CABL001A2202 that were receiving best available therapy (dasatinib) and switched to asciminib when entering this study or during the course of this study |
Taken orally, twice daily (BID) or once daily (QD), in fasting state
Andre navne:
|
|
Eksperimentel: Asciminib single agent formulation for Pediatric
Participants with CML, from Novartis sponsored asciminib studies, including but not limited to CABL001I12201 study, that were receiving asciminib |
Pediatric participants receive a body weight adjusted dose of 1.3 mg/kg of pediatric film coated granules with food twice daily (b.i.d.) or 2.6 mg/kg once daily (q.d.) in the morning.
Andre navne:
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Number of participants with adverse events (AEs) and serious adverse events (SAEs)
Tidsramme: 8 years
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All AEs and SAEs will be tabulated and listed for participants in the Safety Set by treatment group. From day of first administration of study treatment to 30 days after the last study treatment. |
8 years
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Percentage of participants with clinical benefit as assessed by Investigator
Tidsramme: 8 years
|
Investigators' assessment of clinical benefit will collected through the Investigator confirming that the patient is still benefiting from treatment. This will be evaluated and tabulated for participants in the Safety Set by treatment group at each visit. |
8 years
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Studieleder: Novartis Pharmaceuticals, Novartis Pharmaceuticals
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
- Patologiske processer
- Neoplasmer
- Kronisk sygdom
- Sygdomsegenskaber
- Neoplasmer efter histologisk type
- Hæmatologiske sygdomme
- Neoplastiske processer
- Leukæmi, myeloid
- Knoglemarvssygdomme
- Leukæmi
- Celletransformation, neoplastisk
- Karcinogenese
- Patologiske tilstande, tegn og symptomer
- Hemiske og lymfatiske sygdomme
- Myeloproliferative lidelser
- Leukæmi, myelogen, kronisk, BCR-ABL positiv
- Blast krise
- Svovlforbindelser
- Organiske kemikalier
- Heterocykliske forbindelser, 1-ring
- Heterocykliske forbindelser
- Thiazoler
- Azoler
- Kulbrinter
- Kulbrinter, cyklisk
- Carboxylsyrer
- Kulbrinter, aromatisk
- Amider
- Pyrimidiner
- Benzenderivater
- Syrer, carbocykliske
- Benzoates
- Benzamider
- Piperaziner
- Imatinib mesylat
- Dasatinib
- Nilotinib
- Asciminib
- Bosutinib
Andre undersøgelses-id-numre
- CABL001A2001B
- 2021-000602-17 (EudraCT nummer)
- 2023-507557-16-00 (Anden identifikator: EU CTIS)
- 2023 (U.S. NIH-bevilling/kontrakt)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.
This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
IPD-deling Understøttende informationstype
- CSR
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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