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Broad Health Condition Cancer
Cancer
Cancer
Cancer
Cancer
Cancer
Specific Health ConditionLymphoma (non Hodgkin's lymphoma) - High grade lymphoma
Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma
Myeloma
Hodgkin's
Leukaemia - Acute leukaemia
Leukaemia - Chronic leukaemia
Recruitment statusRecruiting
Recruitment Details
Recruitment State
QLD
Hospital
Royal Brisbane & Womens Hospital - Herston
Postcode
4029 - Herston
Has the study received ethics approval?Approved
Trial summary
This study will investigate immune responses to vaccination in patients with blood cancer who have received treatments targeting specific immune cells, B cells, those who have undergone bone marrow transplantation and a group of healthy volunteers who have not been treated for blood cancer or received any immune cell treatments. Who is it for? You may be eligible for this study if you are aged 18 or older, have been diagnosed with a blood cancer (including non Hodgkin's lymphoma, myeloma, Hodgkin's and leukemia) and have received either treatment with a B-cell targeted therapy or received a bone marrow transplant, and you are planning to have a COVID-19 vaccine of any variety. A second group of adults aged 18 and older who do not have a diagnosis of blood cancer or any other active cancer, who have not received treatment with B cell depleting antibodies, and who are also planning to have a COVID-19 vaccine of any variety will also be recruited. Study details Participants who choose to enrol in this study will be asked to provide up to five blood samples, starting up to 1 week beforethe first COVID-19 vaccine dose and continuing until 6 months after the second COVID-19 vaccine dose has been administered. We will also ask to review your medical records over the 12 months after you have received the second dose and may contact you to confirm any positive COVID-19 test results. It is hoped this research will enable researchers to understand how these cancer treatments affect the immune response to COVID-19 vaccination and whether vaccination will provide effective protection in patients with blood cancers.
Key inclusion criteria
1. Greater than or equal to 18 years of age 2. Able to provide voluntary informed consent 3. Planned receipt of a COVID19 vaccine of any variety; e.g. Pfizer-BioNTech BNT162b2, AstraZeneca Oxford ChAdOx1 nCoV-19 (AZD1222), Novavax NVX-CoV2373 or ModernaTX mRNA-1273 vaccine. - Patients who have any haematological malignancy and received treatment with a B-cell targeted therapy or who have received a bone marrow transplant may be recruited to Cohort A. - Patients who do not have a diagnosis of a haematological malignancy or any other active cancer, and who have not received treatment with B cell depleting antibodies will be recruited to Cohort B. 50 patients will be recruited in total, 30 to Cohort A and 20 to Cohort B.
Minimum age18 Years
GenderBoth males and females
Can Healthy volunteers participate?Yes
Key exclusion criteria
1. Current diagnosis of and/or treatment for a non-haematological malignancy. 2. Receipt of B cell targeted therapies for Rheumatological or other non-haematological malignancy indication 3. Unable to provide voluntary informed consent
Sponsor Primary Sponsor Type: Hospital
Primary Sponsor Name: Royal Brisbane and Women's Hospital
Primary Sponsor Address: Butterfield Street
HERSTON QLD 4029
Primary Sponsor Country: Australia
Trial websiteN/A
Trial IDACTRN12621000538842
Contact person for information and recruitmentDr
Andrea Henden
QIMR Berghofer Medical Research Institute
300 Herston Road
HERSTON QLD 4006
and
Royal Brisbane and Women's Hospital
Butterfield Street
HERSTON QLD 4029
+61 7 3845 3968
N/Aandrea.henden@qimrberghofer.edu.au
Australia