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Tyrosine Kinase Inhibitor
Asciminib Continuation for Chronic Myelogenous Leukemia
Phase 4
Recruiting
Research Sponsored by Novartis Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights
Study Summary
This trialis for those who have completed a Novartis trial and may benefit from continued treatment.
Who is the study for?
This trial is for patients with certain types of leukemia (CML or ALL) who are already participating in a Novartis-sponsored study and taking asciminib alone or with other drugs like imatinib, nilotinib, dasatinib, or bosutinib. They should have followed the previous study's rules well and must be seen by their doctor as likely to benefit from continuing treatment.Check my eligibility
What is being tested?
The trial is focused on long-term safety for those continuing treatment with asciminib, either as a single agent or combined with other leukemia medications such as imatinib, nilotinib, dasatinib, or bosutinib after completing an earlier Novartis-sponsored study.See study design
What are the potential side effects?
While specific side effects aren't listed here, long-term use of leukemia treatments like asciminib and others can include risks such as liver problems, digestive issues, blood cell count changes leading to increased infection risk or bleeding problems.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of participabts with adverse events (AEs) and serious adverse events (SAEs)
Secondary outcome measures
Percentage of participants with clinical benefit as assessed by Investigator
Trial Design
8Treatment groups
Experimental Treatment
Group I: Nilotinib single agent groupExperimental Treatment1 Intervention
Participants with CML-CP, from Novartis sponsored asciminib study ABL001E2201 that were receiving nilotinib
Group II: Imatinib single agent groupExperimental Treatment1 Intervention
Participants with CML-CP, from Novartis sponsored asciminib study ABL001E2201 that were receiving imatinib
Group III: Bosutinib-asciminib switch groupExperimental Treatment1 Intervention
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
Group IV: Bosutinib single agent groupExperimental Treatment1 Intervention
Participants with CML-CP, from Novartis sponsored asciminib study ABL001A2301, that were receiving bosutinib
Group V: Asciminib single agent groupExperimental Treatment1 Intervention
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
Group VI: Asciminib in combination with nilotinib groupExperimental Treatment2 Interventions
Participants with CML or ALL from Novartis sponsored asciminib studies ABL001E2201or CABL001X2101 that were receiving asciminib combined with nilotinib
Group VII: Asciminib in combination with imatinib groupExperimental Treatment2 Interventions
Participants with CML from Novartis sponsored asciminib studies ABL001E2201 or CABL001X2101 that were receiving asciminib combined with imatinib
Group VIII: Asciminib in combination with dasatinib groupExperimental Treatment1 Intervention
Participants with CML from Novartis sponsored study ABL001X2101 that were receiving asciminib with dasatinib
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nilotinib
2005
Completed Phase 4
~2670
Asciminib
2018
Completed Phase 1
~570
Bosutinib
2015
Completed Phase 3
~2390
Imatinib
2011
Completed Phase 3
~3940
Dasatinib
2012
Completed Phase 3
~2320
Find a Location
Who is running the clinical trial?
Novartis PharmaceuticalsLead Sponsor
2,858 Previous Clinical Trials
4,197,496 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have followed all requirements in a previous study and can do so for this one too.I am currently being treated with specific drugs for my leukemia and my doctor thinks I should continue.
Research Study Groups:
This trial has the following groups:- Group 1: Bosutinib-asciminib switch group
- Group 2: Asciminib in combination with dasatinib group
- Group 3: Asciminib in combination with imatinib group
- Group 4: Asciminib in combination with nilotinib group
- Group 5: Asciminib single agent group
- Group 6: Bosutinib single agent group
- Group 7: Imatinib single agent group
- Group 8: Nilotinib single agent group
Awards:
This trial has 3 awards, including:- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What dangers have been associated with the concurrent administration of Asciminib and imatinib?
"Our assessment of Asciminib in conjunction with Imatinib is a 3, as the combination has already been approved and granted Phase 4 status."
Answered by AI
Are there any additional reports regarding the efficacy of Asciminib when used in tandem with imatinib?
"Presently, 86 trials are running to assess the efficacy of Asciminib when paired with imatinib. Of these investigations into this drug combination, 21 have reached Phase 3. Ulm and Fukuoka host most of the experiments but there are 2999 other sites conducting research on this therapeutic approach."
Answered by AI
What therapeutic purpose does the Asciminib and imatinib blend usually serve?
"Asciminib and imatinib jointly form a common treatment for newly diagnosed acute lymphoblastic leukaemia, as well as refractory blast phase chronic myelogenous leukemia, muscular dystrophy, and various other forms of relapsing acute lymphoblastic leukaemia."
Answered by AI
Are there any opportunities for participants to join this research project presently?
"Affirmative, according to the resources available on clinicaltrials.gov this trial is currently in search of suitable applicants. This study was initially posted on August 30th 2022 and edited most recently on November 14th 2022. There are 347 patients needed from 1 medical center for proper completion."
Answered by AI
How many participants have thus far volunteered for this experiment?
"Affirmative, according to clinicaltrials.gov the trial is recruiting and has been since its posting on August 30th 2022. The most recent update was on November 14th 2022 and 347 patients are needed from 1 medical centre."
Answered by AI
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