SARS-CoV-2 vaccination response in patients with haematologicaldisease

Phase 1

• Conditions: multiple myeloma (including MGUS)chronic lymphocytic leukemia, chronic myeloid leukemia, acute myeloidleukemia, acute lymphocytic leukemia, non-Hodgkin lymphoma, Hodgkinlymphoma, myelodysplastic syndrome, myeloproliferative disease); MedDRA version: 21.1Level: LLTClassification code 10066481Term: Hematological malignancySystem Organ Class: 100000004864; Therapeutic area: Body processes [G] - Immune system processes [G12]

• Registration Number: EUCTR2021-001107-33-NL
• Lead Sponsor: MUMC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-03-10
• Last Update Posted: 17 March 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 743

Inclusion Criteria

all of the following
criteria:
• Currently treated, previously treated and non-treated patients
diagnosed with a hematological malignancy (defined as: multiple myeloma (including MGUS) chronic lymphocytic leukemia, chronic myeloid leukemia, acute myeloid leukemia, acute lymphocytic leukemia, non-Hodgkin lymphoma, Hodgkin lymphoma, myelodysplastic syndrome, myeloproliferative disease).
Previously treated patient is defined as: treatment < 6 months before vaccination in patients that obtained a complete remission. Exceptions (no time restriction for last treatment) are patients with palliative treatment for ongoing haematological malignancies and patients after autologous and allogeneic stem cell transplantation.
• Patients who are scheduled for and will undergo SARS-CoV-2
vaccination.
• Aged = 18 years.
• Written informed consent.
• Inclusion is irrespective of previously proven or possible (based on
symptoms) COVID-19
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 446
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 288

Exclusion Criteria

excluded from participation in this study:
• Patients previously vaccinated for SARS-CoV-2.
• Patients who have senile dementia, mental impairment or any other psychiatric disorder that prohibits the patient from understanding and giving informed consent.
• Any psychological, familial, sociological or geographical condition
potentially hampering compliance with the study protocol.

Study & Design

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