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

Phase 1

• Conditions: Chronic myeloid leukemia; MedDRA version: 21.0Level: LLTClassification code 10009016Term: Chronic myeloid leukemia in remissionSystem Organ Class: 100000004864; MedDRA version: 21.1Level: LLTClassification code 10009015Term: Chronic myeloid leukemiaSystem Organ Class: 100000004864; MedDRA version: 21.0Level: LLTClassification code 10054352Term: Chronic phase chronic myeloid leukemiaSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]

• Registration Number: EUCTR2020-002850-26-NL
• Lead Sponsor: Albert Schweitzer Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-06-30
• Last Update Posted: 29 November 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• 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 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified