Immune response test as new predictor for successful TKI stop in patients with chronic myeloid leukemia

Vaccination response to pneumococcal antigen as novel predictor for successful tyrosine kinase inhibitor discontinuation in chronic myeloid leukemia: the vaccinSTOP study. - VaccinSTOP study

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2020-002850-26-NL

Enrollment

Registered

2020-06-30

Start date

2020-07-20

Completion date

Unknown

Last updated

2021-11-29

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

Conditions

Chronic myeloid leukemia MedDRA version: 21.0 Level: LLT Classification code 10009016 Term: Chronic myeloid leukemia in remission System Organ Class: 100000004864 MedDRA version: 21.1 Level: LLT Classification code 10009015 Term: Chronic myeloid leukemia System Organ Class: 100000004864 MedDRA version: 21.0 Level: LLT Classification code 10054352 Term: Chronic phase chronic myeloid leukemia System Organ Class: 100000004864

Interventions

Trade Name: PNEUMOVAX 23 Pharmaceutical Form: Solution for injection

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Aged 18 years or older - Written informed consent - Known baseline data on diagnosis and treatment prior to study entry - Eligible for TKI discontinuation according to current HOVON guidelines on the treatment of CML Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 30 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 27

Exclusion criteria

Exclusion criteria: - Previously vaccinated against S. pneumoniae - Known allergy to any constituent of the pneumococcal vaccine - Patients using any immunosuppressive medication, excluding inhalation corticosteroids and ointments containing corticosteroids

Design outcomes

Primary

Measure	Time frame
Main Objective: To assess whether an adequate response to pneumococcal antigen, as a marker of overall humoral immune system reactivity, predicts a sustained treatment-free remission at 12 and 24 months. ;Secondary Objective: To assess frequency of switched memory B-lymphocytes, T-lymphocytes subsets, NK-cells and plasmacytoid dendritic cells prior to treatment discontinuation and to assess whether these lymphocytes subclass frequencies have any predictive value for sustained treatment-free remission or risk for relapse. ;Primary end point(s): Sustained treatment-free remission after tyrosine kinase inhibitor treatment discontinuation.;Timepoint(s) of evaluation of this end point: 12 and 24 months	—

Measure

Time frame

Main Objective: To assess whether an adequate response to pneumococcal antigen, as a marker of overall humoral immune system reactivity, predicts a sustained treatment-free remission at 12 and 24 months. ;Secondary Objective: To assess frequency of switched memory B-lymphocytes, T-lymphocytes subsets, NK-cells and plasmacytoid dendritic cells prior to treatment discontinuation and to assess whether these lymphocytes subclass frequencies have any predictive value for sustained treatment-free remission or risk for relapse. ;Primary end point(s): Sustained treatment-free remission after tyrosine kinase inhibitor treatment discontinuation.;Timepoint(s) of evaluation of this end point: 12 and 24 months

—

Secondary

Measure	Time frame
Secondary end point(s): NA;Timepoint(s) of evaluation of this end point: NA	—

Countries

Netherlands

Contacts

Public ContactPrincipal investigator

Albert Schweitzer Hospital

p.e.westerweel@asz.nl00310786546432

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026