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Tyrosine Kinase Inhibitor

Asciminib in CML patients for Leukemia

Phase 1
Waitlist Available
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 first cycle is 28 days
Awards & highlights

Summary

This trial is testing a new cancer drug to see what dose is safe and tolerated in patients with relapsed or refractory leukemia.

Eligible Conditions
  • Leukemia
  • Acute Lymphoblastic Leukemia

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~first cycle is 28 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and first cycle is 28 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of dose limiting toxicities (DLTs) during the first cycle of study treatment

Trial Design

5Treatment groups
Experimental Treatment
Group I: Asciminib+dasatinib in CML patientsExperimental Treatment2 Interventions
Dose escalation study estimated the MTD and/or RDE of asciminib in combination with dasatinib in adult CML patients
Group II: Asciminib+Nilotinib in CML patientsExperimental Treatment2 Interventions
Dose escalation study estimated the MTD and/or RDE of asciminib in combination with Nilotinib in adult CML patients
Group III: Asciminib+Imatinib in CML patientsExperimental Treatment2 Interventions
Dose escalation study to estimate the MTD and/or RDE of asciminib in combination with imatinib in adult CML patients
Group IV: Asciminib in Ph+ ALL patientsExperimental Treatment1 Intervention
Dose escalation study estimated the MTD and/or RDE of asciminib in adult patients with Ph positive ALL patients
Group V: Asciminib in CML patientsExperimental Treatment1 Intervention
Dose escalation study estimated the maximum tolerated dose (MTD) and/or recommended dose for expansion (RDE) of asciminib in adult patients with chronic myeloid leukemia (CML).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Imatinib
2011
Completed Phase 3
~3940
Dasatinib
2012
Completed Phase 3
~2320
Asciminib (ABL001)
2014
Completed Phase 1
~330
Nilotinib
2005
Completed Phase 4
~2670

Find a Location

Who is running the clinical trial?

Novartis PharmaceuticalsLead Sponsor
2,889 Previous Clinical Trials
4,203,075 Total Patients Enrolled
153 Trials studying Leukemia
23,510 Patients Enrolled for Leukemia
~29 spots leftby Sep 2025
Unbiased ResultsWe believe in providing patients with all the options.
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