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COV-CML - UK retrospective data collection Covid infection in CML patients - volunteers needed.

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COV-CML; A UK NATIONAL RETROSPECTIVE DATA COLLECTION FOR COVID-19 DISEASE /SARS-CoV-2 INFECTION IN CML PATIENTS

Imperial College collected data back in March/April 2020 to identify covid infection cases in UK CML patients.

Currently there are up to 50 patients enrolled. Imperial will report the data to the international CML foundation when, like France, 80 patients are enrolled and their data collected.  France is also reporting cases to iCMLf - they have the highest reporting incidence of Covid at n=80.

Prof.Mhairi Copeland (Glasgow) is a co-investigator in this study.

  • If you have had a Covid infection and would like to help with this study please contact Prof. Dragana Milojkovic by email at dragana.milojkovic@nhs.net

Please note: CML patients who have had a stem cell transplant are not eligible for this study as their immune system has been altered by factors other than TKI therapy.

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SEROPROTECTION AGAINST SARS-CoV-2 IN CML PATIENTS RECEIVING TKI THERAPY

IRAS Project ID: 289527; REC reference: 21/SC/0016, Hammersmith Hospital, Imperial College NHS Trust, London UK

Study Summary:

This study will evaluate the efficacy of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccine in chronic myelogenous leukaemia (CML) patients on tyrosine kinase inhibitor (TKI) therapy.

It is a prospective study to determine the safety and immunogenicity of the SARS-Cov-2 vaccine in CML patients and healthy controls to characterize the different components of the immune response post vaccination.

Vaccination itself is not part of the study as a protocol mandated intervention. Instead, the study will recruit eligible CML patients who are planned to have SARS-CoV-2 vaccination through the routine NHS care and given according to DoH recommendations to CML patients (Group A) and healthy NHS staff or other healthy individuals (Group B).

Previous studies in patients with haematological malignancy have shown that the level of humoral immunity induced by the H1N1 vaccine in patients appears to be influenced by both the underlying malignancy, and its treatment (de Lavallade, et al, 2011). Some of the tyrosine kinase targets of BCR-ABL inhibitors play a role in immune responses and there are theoretical reasons to suggest an altered immune reactivity. Contradictory reports of the immunomodulatory effects of TKIs range from impaired T-cell responses to enhanced responses to vaccination.

Evaluation of COVID vaccine responses in CML patients, the level of seroprotection and infection rates post vaccination are an important assessment to advise on-going clinical care and shielding practices in the future throughout the COVID pandemic.

Inclusion criteria: CML in chronic phase in complete cytogenetic response (CCyR) or better, on treatment with any of the TKIs, age ≥18 years.

Assessment needs to be done BEFORE vaccination and then at the following time points:  day 21, day 49, at 12 weeks ( pre-booster), 6 months and 1 year.
If you are interested in participating before you receive the COVID vaccine please email Prof Dragana Milojkovic at dragana.milojkovic@nhs.net