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Clinical Trials/EUCTR2020-002850-26-NL
EUCTR2020-002850-26-NL
Active, not recruiting
Phase 1

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

Albert Schweitzer Hospital0 sites57 target enrollmentJune 30, 2020
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ConditionsChronic myeloid leukemiaMedDRA version: 21.0Level: LLTClassification code 10009016Term: Chronic myeloid leukemia in remissionSystem Organ Class: 100000004864MedDRA version: 21.1Level: LLTClassification code 10009015Term: Chronic myeloid leukemiaSystem Organ Class: 100000004864MedDRA version: 21.0Level: LLTClassification code 10054352Term: Chronic phase chronic myeloid leukemiaSystem Organ Class: 100000004864Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
DrugsPNEUMOVAX 23

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Chronic myeloid leukemia
Sponsor
Albert Schweitzer Hospital
Enrollment
57
Status
Active, not recruiting
Last Updated
4 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
June 30, 2020
End Date
TBD
Last Updated
4 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Eligibility 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

  • •\-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

Outcomes

Primary Outcomes

Not specified

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