Status:

COMPLETED

Pneumococcal Vaccine in Untreated CLL Patients

Lead Sponsor:

Karolinska University Hospital

Conditions:

Chronic Lymphocytic Leukemia

Eligibility:

All Genders

18-90 years

Phase:

PHASE3

Brief Summary

The purpose of the study is to determine whether patients with chronic lymphocytic leukaemia (CLL) will benefit from vaccination with a 13-valent conjugated pneumococcal vaccine, Prevenar13, compared ...

Eligibility Criteria

Inclusion

  • 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

Exclusion

  • Immunosuppressive therapy planned to start within 1 month
  • Other malignancies
  • Corticosteroids or other immunosuppressive drugs
  • Previous allergic reaction to any vaccination in the past
  • Neutropenia (PMNs \< 500 cells/mm3)

Key Trial Info

Start Date :

August 1 2013

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

December 1 2015

Estimated Enrollment :

134 Patients enrolled

Trial Details

Trial ID

NCT01892618

Start Date

August 1 2013

End Date

December 1 2015

Last Update

January 15 2016

Active Locations (1)

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1

Karolinska University Hospital

Stockholm, Stockholm County, Sweden, 14186