A Randomized Phase III Trial to Determine Whether Conjugated Pneumococcal Vaccine Can Improve the Immune Responsiveness Compared to Polyclonal Pneumococcal Vaccine in Patients With Untreated Chronic Lymphocytic Leukemia.Study AmendmentStudy Extension - Long term follow up on effect on immune response in patients with chronic lymphocytic leukemia vaccinated with pneumococcal vaccine, PCV13 or PPSV23, and evaluation of the effect of revaccination.

Swedish CLL-group0 个研究点目标入组 126 人开始时间: 2009年10月19日最近更新: 2018年6月11日

适应症

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•Untreated CLL patients all Rai stages (0 to IV), as early as possible after diagnosis, always before any therapy with monoclonal antibodies and /or chemotherapy.
•Extension study:
•CLL patients earlier included in the Pneumococcal vaccination study, who have received either PPSV23 or PCV13 and who have not received any additional pneumococcal vaccine outside the study protocol after 2013-2016 are eligible for analysis of the long-term immune response. The same patients are eligible for revaccination if they do not meet any exclusion criteria. Ongoing or recent CLL specific treatment is not an exclusion criteria.
•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 31
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range 95

•Patients for whom immunosuppressive therapy is planned to start within one month.
•Patients with other malignancies
•Patients receiving corticosteroids or other immunosuppressive drugs
•Patients who have had an allergic reaction to any vaccination in the past
•Patients with neutropenia (PMNs < 500 cells/mm3)
•Patients with a positive DAT (Direct Antiglobulin Test) or known previous hemolysis
•Patients failing to give informed consent.
•Patients with ongoing immunoglobulin therapy
•Patients with known HIV infection
•Patients who have previously received pneumococcal vaccine within 5 years
•Active infection
•Extension study:
•Patients receiving high dose corticosteroids or other immunosuppressive drugs that is not part of active CLL treatment
•Patients who have had an allergic reaction to any vaccination in the past
•Patients with a positive DAT (Direct Antiglobulin Test) or known present or previous hemolysis, ITP and Guillain-Barre
•Patients failing to give informed consent
•Patients with ongoing immunoglobulin therapy
•Patients with known HIV infection
•Patients who have received a pneumococcal vaccine after the study vaccine was given.
•Active infection

发起方

Swedish CLL-group