Asciminib Roll-over Study

Sponsor
Novartis Pharmaceuticals (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT04877522
Collaborator
(none)
230
Enrollment
7
Arms
55.9
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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

Condition or DiseaseIntervention/TreatmentPhase
Phase 3

Detailed Description

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 the parent study, or from switching to asciminib (if they were on bosutinib in the parent study), but are unable to access this treatment outside of the clinical study.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
230 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
An Open Label, Multi-center Asciminib Roll-over Study to Assess Long-term Safety in Patients Who Have Completed a Novartis Sponsored Asciminib Study and Are Judged by the Investigator to Benefit From Continued Treatment
Anticipated Study Start Date :
May 16, 2022
Anticipated Primary Completion Date :
Jan 12, 2027
Anticipated Study Completion Date :
Jan 12, 2027

Arms and Interventions

ArmIntervention/Treatment
Experimental: Asciminib 40 mg BID single agent group

participants with CML-CP, from Novartis sponsored asciminib studies, including but not limited to ABL001A2301 and ABL001A2202 studies, that were receiving asciminib

Drug: Asciminib single agent
Taken orally, twice daily, in fasting state
Other Names:
  • ABL001
  • Procedure: Pregnancy test
    All pre-menopausal women who are not surgically sterile will have a serum pregnancy testing performed at each study visit and monthly urine tests to be performed at home.
    Other Names:
  • HCG
  • Other: Bosutinib single agent group

    participants with CML-CP, from Novartis sponsored asciminib study ABL001A2301, that were receiving bosutinib

    Drug: Bosutinib
    Taken orally, once daily, with food

    Procedure: Pregnancy test
    All pre-menopausal women who are not surgically sterile will have a serum pregnancy testing performed at each study visit and monthly urine tests to be performed at home.
    Other Names:
  • HCG
  • Experimental: Bosutinib-asciminib switch group

    participants with CML-CP, from Novartis sponsored asciminib study ABL001A2301 that were receiving bosutinib treatment and switched to asciminib when entering this study or during the course of this study

    Drug: Asciminib single agent
    Taken orally, twice daily, in fasting state
    Other Names:
  • ABL001
  • Procedure: ECG
    Participants on bosutinib that intend to switch to asciminib need to perform ECGs to evaluate the QTcF
    Other Names:
  • electrocardiogram
  • Procedure: Pregnancy test
    All pre-menopausal women who are not surgically sterile will have a serum pregnancy testing performed at each study visit and monthly urine tests to be performed at home.
    Other Names:
  • HCG
  • Experimental: Asciminib 40 mg QD combined with imatinib group

    participants with CML-CP, from Novartis sponsored asciminib study ABL001E2201 that were receiving asciminib combined with imatinib

    Drug: Asciminib
    Taken orally, once daily, in the morning with low-fat meal
    Other Names:
  • ABL001
  • Drug: Imatinib
    Taken orally, once daily, in the morning with low-fat meal
    Other Names:
  • STI-571
  • Procedure: Pregnancy test
    All pre-menopausal women who are not surgically sterile will have a serum pregnancy testing performed at each study visit and monthly urine tests to be performed at home.
    Other Names:
  • HCG
  • Experimental: Asciminib 60 mg QD combined with imatinib group

    participants with CML-CP, from Novartis sponsored asciminib study ABL001E2201 that were receiving asciminib combined with imatinib

    Drug: Asciminib
    Taken orally, once daily, in the morning with low-fat meal
    Other Names:
  • ABL001
  • Drug: Imatinib
    Taken orally, once daily, in the morning with low-fat meal
    Other Names:
  • STI-571
  • Procedure: Pregnancy test
    All pre-menopausal women who are not surgically sterile will have a serum pregnancy testing performed at each study visit and monthly urine tests to be performed at home.
    Other Names:
  • HCG
  • Other: Imatinib single agent group

    participants with CML-CP, from Novartis sponsored asciminib study ABL001E2201 that were receiving imatinib

    Drug: Imatinib
    Taken orally, once daily, in the morning with low-fat meal
    Other Names:
  • STI-571
  • Procedure: Pregnancy test
    All pre-menopausal women who are not surgically sterile will have a serum pregnancy testing performed at each study visit and monthly urine tests to be performed at home.
    Other Names:
  • HCG
  • Other: Nilotinib single agent group

    participants with CML-CP, from Novartis sponsored asciminib study ABL001E2201 that were receiving nilotinib

    Drug: Nilotinib
    Taken orally, twice daily, on an empty stomach
    Other Names:
  • AMN107
  • Procedure: Pregnancy test
    All pre-menopausal women who are not surgically sterile will have a serum pregnancy testing performed at each study visit and monthly urine tests to be performed at home.
    Other Names:
  • HCG
  • Outcome Measures

    Primary Outcome Measures

    1. Number of participabts with adverse events (AEs) and serious adverse events (SAEs) [5 years]

      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.

    Secondary Outcome Measures

    1. Percentage of participants with clinical benefit as assessed by Investigator [5 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Key Inclusion Criteria:
    1. Participant with CML-CP that is currently receiving treatment with asciminib, asciminib in combination with imatinib, imatinib alone, nilotinib alone or bosutinib within a Novartis-sponsored study and, in the opinion of the Investigator, would benefit from continued treatment.

    2. 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:
    1. Participant has been discontinued from parent study treatment.

    2. Participant currently has unresolved toxicities reported as possibly related to study treatment in the parent study.

    3. Participant's ongoing treatment is currently approved and reimbursed at country level.

    4. Pregnant or nursing (lactating) women.

    5. Women of child-bearing potential, unless they are using highly effective methods of contraception and willing to continue while taking study treatment.

    6. For participants in the USA and on asciminib treatment only: Sexually active males unwilling to use a condom during intercourse while taking study treatment.

    7. Applicable only for participants on bosutinib treatment that switch to asciminib treatment at enrollment:

    • Asymptomatic pancreatitis

    • abnormal ECG

    Other protocol-defined Inclusion/Exclusion criteria may apply.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Novartis Pharmaceuticals

    Investigators

    • Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Novartis Pharmaceuticals
    ClinicalTrials.gov Identifier:
    NCT04877522
    Other Study ID Numbers:
    • CABL001A2001B
    • 2021-000602-17
    First Posted:
    May 7, 2021
    Last Update Posted:
    Nov 29, 2021
    Last Verified:
    Nov 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Novartis Pharmaceuticals
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Nov 29, 2021