Asciminib Roll-over Study

Part of paid clinical trials in Ann Arbor, Michigan.

Sponsor
Novartis Pharmaceuticals
Study ID
NCT04877522
Phase
PHASE4
Status
Recruiting
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Conditions

  • Chronic Myelogenous Leukemia
  • Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Eligibility Criteria

Sex
ALL
Age
7 Years - 100 Years
Healthy Volunteers
Not accepted

Interventions

  • Asciminib single agent — DRUG
    Taken orally, twice daily (BID) or once daily (QD), in fasting state
  • Imatinib — DRUG
    Taken orally, once daily, in the morning with low-fat meal
  • Nilotinib — DRUG
    Taken orally, twice daily, on an empty stomach
  • Bosutinib — DRUG
    Taken orally, once daily, with food
  • Dasatinib — DRUG
    Taken orally, once daily in a fasted state, 1 or 2 hours before a meal
  • Asciminib single agent pediatric formulation — DRUG
    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.

Study Details

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

Key Dates

Start date
Aug 30, 2022
Status verified
Jun 2026
Primary completion
Aug 30, 2030
Completion
Aug 30, 2030

Study Design

Enrollment
347 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: 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
  • Other: Bosutinib single agent group
    Participants with CML-CP, from Novartis sponsored asciminib study CABL001A2301, that were receiving bosutinib
  • Experimental: 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
  • Experimental: Asciminib in combination with imatinib group
    Participants with CML from Novartis sponsored asciminib studies CABL001E2201 or CABL001X2101 that were receiving asciminib combined with imatinib
  • Experimental: 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
  • Other: Imatinib single agent group
    Participants with CML-CP, from Novartis sponsored asciminib study CABL001E2201 that were receiving imatinib
  • Other: Nilotinib single agent group
    Participants with CML-CP, from Novartis sponsored asciminib study CABL001E2201 and CABL001J12302 that were receiving nilotinib
  • Experimental: Asciminib in combination with dasatinib group
    Participants with CML from Novartis sponsored study CABL001X2101 that were receiving asciminib with dasatinib
  • Other: Dasatinib single agent group
    Participant with CML-CP , from Novartis sponsored asciminib study CABL001A2202, CABL001J12301, that were receiving Dasatinib.
  • Experimental: 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
  • Experimental: 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

Primary Outcome Measure

Number of participants with adverse events (AEs) and serious adverse events (SAEs) [ Time Frame: 8 years ]

Central Contacts

  • Novartis Pharmaceuticals
    1-888-669-6682
    [email protected]
  • Novartis Pharmaceuticals
    +41613241111

Locations (6)

FacilityCityStateZIPSite coordinators
Michigan Med University of MichiganAnn ArborMichigan48109 5271
Kelly Whitley
[email protected]
Moshe Talpaz (PRINCIPAL_INVESTIGATOR)
Memorial Sloan KetteringNew YorkNew York10017
Shakira Pascual
[email protected]
646-497-9068
Michael Mauro (PRINCIPAL_INVESTIGATOR)
Oregon Health Sciences UniversityPortlandOregon97239-
Texas OncologyDallasTexas75251
Jessica Maner
[email protected]
+1 214 370 1000
Moshe Yair Levy (PRINCIPAL_INVESTIGATOR)
Uni Of TX MD Anderson Cancer CntrHoustonTexas77030
Susan Aline Wahl
[email protected]
+1 713 792 2921
Fadi Haddad (PRINCIPAL_INVESTIGATOR)
Medical College of WisconsinMilwaukeeWisconsin53226
Esta Konkol
[email protected]
414-805-6803
Ehab Atallah (PRINCIPAL_INVESTIGATOR)

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Michigan Med University of Michigan· Ann Arbor, MIMemorial Sloan Kettering· New York, NYOregon Health Sciences University· Portland, ORTexas Oncology· Dallas, TXUni Of TX MD Anderson Cancer Cntr· Houston, TXMedical College of Wisconsin· Milwaukee, WI

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