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A centre-based chart review study to assess treatment outcomes of venetoclax for the treatment of acute myeloid leukemia (AML)

Study ID: 55421
Short Title: Chart review assessing venetoclax treatment outcomes for AML (ARC) v1
Trust Name: PHU
Recruitment Site: Queen Alexandra Hospital
Disease Area: Haematology
Phase: N/A
Expected End Date: 08/04/2024
Postcode: PO6 3LY
Contact Name: Amanda Pattie
Contact Email: studysupport1and3.crnwessex@nihr.ac.uk
Active: Yes

▪The patient received a diagnosis for AML, if available, suggested diagnosis codes: ICD-9 205.0x or ICD-10 C92.0x, C92.4x, C92.5x ▪ The patient was at least 18 years old at AML diagnosis date ▪ The patient was initiated on the studied line of therapy (first line venetoclax regimen per the indicated label in GB) for previously untreated AML: ▪ Venetoclax in combination with an HMA (on or after 28th May 2021) or LDAC (on or after 25th February 2022), the date of MHRA approvals of venetoclax (for the treatment of adult patients with newly diagnosed AML who are ineligible for intensive chemotherapy) ▪ The patient was treated with the studied line of therapy at least 28 days prior to date of data collection ▪ Information on the patient's treatments, selected (or important) clinical characteristics, and outcomes is available from the start of the studied line of therapy onwards

▪ The patient received the studied line of therapy as part of a clinical trial ▪ Patient received prior lines of therapy for AML ▪ The patient has a history of malignancies within 2 years prior to the studied line of therapy, other than AML, and with the exception of: o Myelodysplastic syndromes (MDS), myeloproliferative neoplasm (MPN) or chronic myelomonocytic leukemia (CMML) o Adequately treated in situ carcinoma of the cervix uteri or carcinoma in situ of breast o Basal cell carcinoma of the skin or localized squamous cell carcinoma of the skin o Previous malignancy confined and surgically resected (or treated with other modalities) with curative intent

This study investigates venetoclax use in the treatment of acute myeloid leukaemia (AML) in Great Britain (GB). Venetoclax is a treatment for AML that was recently approved in GB. Venetoclax is given as a combination with other medications, with different combinations available, for AML patients who have never received a previous treatment and who cannot receive intensive chemotherapy. Clinical trials have shown venetoclax works well compared to other medications, but currently there is limited information on how it works in everyday clinics. This study will help provide information on how this treatment is used in the real world. The study aims to describe how well this treatment works, including survival, time the treatment continues to work for the patient, how often patients have to visit their doctor or hospital when taking the treatment, and how different treatment combinations are used in GB overall. This multi-centre study will be run across eight to nine sites. Doctors will review medical records for AML patients treated with different venetoclax combinations and enter patient information into an online form. Patients themselves are not directly involved, and there will be no changes to their care. The study aims to include data for 150-200 adult patients with AML (aged 18 years or older at AML diagnosis) who are taking a venetoclax combination treatment (for at least 28 days) because they cannot receive chemotherapy. Patient demographics (e.g. age, sex), clinical characteristics (e.g. other diseases or medical conditions a patient has at the time), treatment patterns (e.g. when the treatment was taken and how much was taken), effectiveness (how well the medicine works including survival), and how often patients visit their doctor or hospital whilst taking the treatment will be collected. Information that cannot reveal the patient’s identity will be collected, and this will be anonymised in the final database.

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