Chart review assessing venetoclax treatment outcomes for AML - AML Real World Evidence Initiative (ARC)

Not Applicable

Completed

• Conditions: Acute myeloid leukaemia; Cancer

• Registration Number: ISRCTN16805365
• Lead Sponsor: AbbVie (United Kingdom)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-11-10
• Study Completion: 2024-05-06
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 168

Inclusion Criteria

1. 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
2. The patient was at least 18 years old at AML diagnosis date
3. The patient was initiated on the studied line of therapy (see Table 1 for the list of eligible treatments included based on NCCN guidelines and clinical input) for previously untreated AML:
3.1. 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)
4. The patient was treated with the studied line of therapy at least 28 days prior to the date of data collection
5. 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

Exclusion Criteria

1. The patient received the studied line of therapy as part of a clinical trial
2. The patient received prior lines of therapy for AML
3. 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:
3.1. Myelodysplastic syndromes (MDS), myeloproliferative neoplasm (MPN) or chronic myelomonocytic leukemia (CMML)
3.2. Adequately treated in situ carcinoma of the cervix uteri or carcinoma in situ of the breast
3.3. Basal cell carcinoma of the skin or localized squamous cell carcinoma of the skin
3.4. Previous malignancy confined and surgically resected (or treated with other
modalities) with curative intent

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Overall survival (OS) will be measured as the number of days between the initiation of the studied line of therapy (i.e., venetoclax-based regimen) until death (event) or end of follow-up (censoring). <br>2. Event-free survival (EFS) will be measured as the number of days between initiating the studied line of therapy and disease progression, refractory disease, or death; both outcomes will be censored at the end of follow-up.

Secondary Outcome Measures

Name	Time	Method
1. AML healthcare resource utilisation (HRU) measured using data entered into the electronic data capture (EDC) system at one timepoint<br>2. AML treatment patterns for the venetoclax cohort measured using data entered into the electronic data capture (EDC) system at one timepoint