Acute myeloid leukaemia, COVID-19 (SARS-CoV-2 infection) Cancer
Conditions
Interventions
Patients with AML may participate in this study if they have a newly diagnosed disease, if they are currently receiving treatment for AML or if their AML has returned (relapsed) and they are due to ha
Sponsors
University of Birmingham
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Acute myeloid leukaemia (AML) including known AML presenting with relapse or Myelodysplastic Syndrome With Excess Blasts (MDS-EB2) 2. Currently receiving (at any treatment stage), or planned for, intensive (i.e. curative intent) or non-intensive chemotherapy. Intensive treatment includes regimens including Daunorubicin/Cytarabine, Fludarabine/Cytarabine/Idarubicin, intermediate/high dose Cytarabine, CPX-351, Gemtuzumab Ozogamacin, Midostaurin. Non-intensive treatments include Azacitidine, low dose Cytarabine, and Venetoclax based regimens. 3. Written informed consent to participate
Exclusion criteria
Exclusion criteria: 1. Aged <16 years 2. Undergoing allogeneic stem cell transplant at trial entry 3. Supportive care only (including hydroxycarbamide alone) 4. Acute promyelocytic leukaemia (APML)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of COVID-19 infection developing during AML treatment measured using SAR-CoV-2 PCR test and from hospital records from baseline until 4 weeks subsequent to the last cycle of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Prospective study outcomes: 1. Symptoms and severity of COVID-19 infection in patients with AML measured using patient notes (of patient hospitalisation, requiring oxygen, and ITU admission), completing weekly follow-up forms (was oxygen saturation <92% and does the patient have sustained increased respiratory rate?) between baseline and 24 months 2. Survival at Day 30 and 60, with or without a diagnosis of COVID-19 at presentation, or at any stage, measured using CRFs, monthly follow up forms, treatment form, and baseline form at 30 and 60 days 3. Overall survival measured using patient notes at first diagnosis until death 4. The number of episodes of bacteraemia/presumed fungal infection in AML patients measured using patient notes, all documented in the admission/infection form (reviewing if blood culture was performed, serum fungal test performed, and CT chest performed) between baseline and 24 months 5. The severity of episodes of bacteraemia/presumed fungal infection in AML patients measured using the length of the episode, days in ICU, duration of hypotension, and CTCAE V4 grading between baseline and 24 months 6. Use of anti-viral agents as prophylaxis and therapy in this high-risk population (including convalescent plasma) measured using the number of occasions anti-viral agents were used (including convalescent plasma), and the number and proportion of patients who have received them, recorded in hospital records between baseline and 24 months 7. Prevalence of prior COVID-19 infection at the time of AML presentation measured using the presence of positive IgG (although recognising that some patients with AML may have significant hypogammaglobulinaemia) at baseline 8. Development of COVID-19 antibodies (IgG and/or IgM) during AML treatment measured using the presence of positive IgG (although recognising that some patients with AML may have significant hypogammaglobulinaemia) at 24 months Retrospective cohort outcomes: 1. Symptoms and severity of COVID-19 | — |
Countries
England, Northern Ireland, Scotland, United Kingdom, Wales
Contacts
Public ContactTina Tang
Outcome results
None listed