Vaccination response to pneumococcal antigen as novel predictor for successful tyrosine kinase inhibitor discontinuation in chronic myeloid leukemia.

Recruiting

Conditions: Chronic myeloid leukemia. Chronic blood cancer.
10024324

Registration Number: NL-OMON55091

Lead Sponsor: Albert Schweitzer Ziekenhuis

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 57

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 (anno
2018) on the treatment of CML

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

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The positive predictive value of an adequate pneumococcal vaccination response<br /><br>for sustained TFR at 12 and 24 months.<br /><br><br /><br>An adequate vaccination resposne will be defined as achieving anti-pneumococcal<br /><br>IgG levels of > 1,0 ug/ml for >10 included serotypes.<br /><br>Sustained TFR will be defined as major molecular response (MMR; BCR-ABL1 <<br /><br>0.1%IS) at 12 and 24 months.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- To assess frequency prior to and after vaccination of immunologic<br /><br>(lymphocyte) subsets (subsets divided based on certain flowcytometric<br /><br>parameters)<br /><br>- To assess whether these lymphocytes subset frequencies have any predictive<br /><br>value for sustained treatment-free remission or risk for relapse. </p><br>