RecruitingNot a traditional drug phaseobservationalRules rewrite

A Study on the Tolerability, Safety and Effectiveness of Asciminib in Patients With Philadelphia Chromosome…

The aim of this study is to assess the real-world effectiveness of asciminib in Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase (Ph+ CML-CP) patients who were either newly diagnosed or previously treated with one ATP-competitive tyrosine kinase inhibitor (TKI).

Official registry: https://clinicaltrials.gov/study/NCT07549516 · Novartis Pharmaceuticals · enrollment listed as 380

What this phase means

This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.

They plan to enroll about 380 people at 63 sites. Taking part typically means study visits and measurements plus check-ins.

Official title (unrewritten)

A Non-Interventional Study on the Tolerability, Safety and Effectiveness of Asciminib in Newly Diagnosed and Pre-treated Patients With Philadelphia Chromosome-positive Chronic Myeloid Leukemia in the Chronic Phase in Germany - the ASC2ADHERE Study

Primary outcome (registry wording): Percentage of Patients With Major Molecular Response (MMR) at 12 Months

Who it is for (from inclusion criteria)

Ages 18 Years to 100 Years

Who the registry excludes

In first- or second-line treatment: presence of BCR::ABL1 fusion transcripts lacking exon a2 (e.g. e13a3, e14a3, e1a3)
In second-line treatment:
known BCR::ABL1 mutations associated with partial or complete resistance to asciminib (e.g. M244V, F359I/V/C)
presence of the BCR::ABL1 T315I mutation, regardless of eligibility for treatment according to SmPC (e.g., specific indication and dosing regimens)
Patients receiving or planned to receive asciminib or other TKIs outside the approved label (off-label use), including use in unapproved dosing regimens or frequency not covered by the respective SmPC
Patients currently participating in an treatment clinical trial
Patients who are unable to reliably complete patient-reported outcome questionnaires due to cognitive or language limitations relevant to the study assessments

Public study contact (from the registry)

Novartis Pharmaceuticals

+41613241111

novartis.email@novartis.com

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

63 listed

Novartis Investigative Site — Baden-Baden, Baden-Wurttemberg, Germany (recruiting)
Novartis Investigative Site — Heidenheim, Baden-Wurttemberg, Germany (recruiting)
Novartis Investigative Site — Schwäbisch Hall, Baden-Wurttemberg, Germany (recruiting)
Novartis Investigative Site — Winnenden, Baden-Wurttemberg, Germany (recruiting)
Novartis Investigative Site — Aschaffenburg, Bavaria, Germany (recruiting)
Novartis Investigative Site — Augsburg, Bavaria, Germany (recruiting)
Novartis Investigative Site — Donauwörth, Bavaria, Germany (recruiting)
Novartis Investigative Site — Herrsching am Ammersee, Bavaria, Germany (recruiting)
Novartis Investigative Site — Kempten (Allgäu), Bavaria, Germany (recruiting)
Novartis Investigative Site — Landsberg am Lech, Bavaria, Germany (recruiting)
Novartis Investigative Site — Munich, Bavaria, Germany (recruiting)
Novartis Investigative Site — Regensburg, Bavaria, Germany (recruiting)

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FAQ about this NCT record

Is NCT07549516 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT07549516?

Not a traditional drug phase. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT07549516?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary