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Asciminib Roll-over Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04877522
Recruitment Status : Recruiting
First Posted : May 7, 2021
Last Update Posted : January 30, 2023
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Study Description
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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 disease Intervention/treatment Phase
Chronic Myelogenous Leukemia Leukemia, Myelogenous, Chronic, BCR-ABL Positive Drug: Asciminib single agent Drug: Asciminib Drug: Imatinib Drug: Nilotinib Drug: Bosutinib Drug: Dasatinib 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
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 347 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
Actual Study Start Date : August 30, 2022
Estimated Primary Completion Date : August 30, 2027
Estimated Study Completion Date : August 30, 2027

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Asciminib single agent group
Participants with CML or ALL, from Novartis sponsored asciminib studies, including but not limited to ABL001A2301, ABL001X2101 and ABL001A2202 studies, that were receiving asciminib
 Drug: Asciminib single agent
Taken orally, twice daily (BID) or once daily (QD), in fasting state
Other Name: ABL001
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
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 (BID) or once daily (QD), in fasting state
Other Name: ABL001
Experimental: Asciminib in combination with imatinib group
Participants with CML from Novartis sponsored asciminib studies ABL001E2201 or CABL001X2101 that were receiving asciminib combined with imatinib
 Drug: Asciminib
Taken orally, once daily, in the morning with low-fat meal or twice daily in fasting state
Other Name: ABL001

Drug: Imatinib
Taken orally, once daily, in the morning with low-fat meal
Other Name: STI571
Experimental: Asciminib in combination with nilotinib group
Participants with CML or ALL from Novartis sponsored asciminib studies ABL001E2201or CABL001X2101 that were receiving asciminib combined with nilotinib
 Drug: Asciminib
Taken orally, once daily, in the morning with low-fat meal or twice daily in fasting state
Other Name: ABL001

Drug: Imatinib
Taken orally, once daily, in the morning with low-fat meal
Other Name: STI571
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 Name: STI571
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 Name: AMN107
Experimental: Asciminib in combination with dasatinib group
Participants with CML from Novartis sponsored study ABL001X2101 that were receiving asciminib with dasatinib
 Drug: Dasatinib
Taken orally, once daily in a fasted state, 1 or 2 hours before a meal
Other Name: Sprycel


Outcome Measures
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Primary Outcome Measures :
  1. Number of participabts with adverse events (AEs) and serious adverse events (SAEs) [ Time Frame: 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 [ Time Frame: 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
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

  1. 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.
  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. Sexually active males receiving imatinib, nilotinib, bosutinib or dasatinib unwilling to follow the relevant contraception requirements in the local prescribing information.

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

    • Asymptomatic pancreatitis
    • abnormal ECG
    • 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.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04877522


Contacts
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Contact: Novartis Pharmaceuticals 1-888-669-6682 novartis.email@novartis.com
Contact: Novartis Pharmaceuticals +41613241111

Locations
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Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
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Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
More Information
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Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT04877522    
Other Study ID Numbers: CABL001A2001B
2021-000602-17 ( EudraCT Number )
First Posted: May 7, 2021    Key Record Dates
Last Update Posted: January 30, 2023
Last Verified: January 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

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
Supporting Materials: Clinical Study Report (CSR)

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Chronic Myelogenous Leukemia
CML
ALL
CML-AP
CML-BP
CML-CP
 myeloproliferative neoplasm
chronic phase
accelerated phase
blast phase
ABL001
asciminib
Additional relevant MeSH terms:
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Leukemia
Leukemia, Myeloid
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Neoplasms by Histologic Type
Neoplasms
Myeloproliferative Disorders
Bone Marrow Diseases
Hematologic Diseases
Niacinamide
Imatinib Mesylate
 Dasatinib
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Vitamin B Complex
Vitamins
Micronutrients
Physiological Effects of Drugs