Asciminib Roll-over Study

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion 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.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT04877522
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 4
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Novartis Pharmaceuticals
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Novartis Pharmaceuticals
Principal Investigator Affiliation	Novartis Pharmaceuticals
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Recruiting
Countries	Argentina, Austria, Brazil, Bulgaria, Canada, Czechia, Denmark, France, Germany, Italy, Japan, Korea, Republic of, Lebanon, Mexico, Poland, Portugal, Romania, Russian Federation, Saudi Arabia, Singapore, Spain, Taiwan, Turkey, United Kingdom, United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Chronic Myelogenous Leukemia, Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Additional Details

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.

Arms & Interventions

Arms

Experimental: Asciminib single agent group

Participants with CML or ALL, from Novartis sponsored asciminib studies, including but not limited to ABL001A2301, ABL001A2302, ABL001X2101, ABL001A2202, ABL001AUS04 and ABL001AUS08 studies, that were receiving asciminib

Other: Bosutinib single agent group

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

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

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

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

Other: Imatinib single agent group

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

Other: Nilotinib single agent group

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

Experimental: Asciminib in combination with dasatinib group

Participants with CML from Novartis sponsored study ABL001X2101 that were receiving asciminib with dasatinib

Interventions

Drug: - Asciminib single agent

Taken orally, twice daily (BID) or once daily (QD), in fasting state

Drug: - Asciminib

Taken orally, once daily, in the morning with low-fat meal or twice daily in fasting state

Drug: - Imatinib

Taken orally, once daily, in the morning with low-fat meal

Drug: - Nilotinib

Taken orally, twice daily, on an empty stomach

Drug: - Bosutinib

Taken orally, once daily, with food

Drug: - Dasatinib

Taken orally, once daily in a fasted state, 1 or 2 hours before a meal

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Michigan Med University of Michigan ., Ann Arbor, Michigan

Status

Recruiting

Address

Michigan Med University of Michigan .

Ann Arbor, Michigan, 48109 5271

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