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Observational study for deep molecular response and cytotoxic T lymphocyte clonality in chronic myeloid leukemia patients treated with asciminib

Observational study for deep molecular response and cytotoxic T lymphocyte clonality in chronic phase chronic myeloid leukemia patients treated with asciminib - Cyclon-Asc study

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
JPRN
Registry ID
JPRN-jRCT1070250023
Enrollment
14
Registered
2025-05-19
Start date
2025-05-17
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic myeloid leukemia

Interventions

None listed

Sponsors

Jo Tatsuro
Lead Sponsor
Novartis Pharma
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Chronic phase Chronic myeloid leukemia (CP-CML) patients during or after treatment with aciminib 2) Patients must be at least 18 years of age. 3) Patients whose written consent was obtained prior to enrollment 4) Patients who can provide sufficient quantities of stored samples for the study

Exclusion criteria

Exclusion criteria: (1) Patients with psychosis or psychiatric symptoms that would prevent the principal investigator or subinvestigator from participating in the study. (2) Patients who have a disease causing immunodeficiency or immunosuppression, or who are receiving immunosuppressive therapy. (3) Patients participating in other clinical trials at the time of enrollment. (4) Patients deemed inappropriate by the principal investigator or subinvestigator to participate in the study.

Design outcomes

Primary

MeasureTime frame
1) Changes in molecular response during asiminib treatment 2) Acquisition of memory cytotoxic T lymphocytes and their transition

Secondary

MeasureTime frame
1) Transition in MR after discontinuation of asiminib. 2) Differences in immunological markers, such as memory CTL, between patients treated with asiminib and those with other tyrosine kinase inhibitors (historical controls). 3) Changes in CTL against CML-specific tumor antigens in patients with HLA-A*02:01 (02:06) or HLA-A*24:02.

Contacts

Public ContactTatsuro Jo

Japanese Red Cross Nagasaki Genbaku Hospital

tjmahamayurijnt@gmail.com+81-95-847-1511

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026