Real World Outcomes Using Novel Agents for AML in the UK

Guy's and St Thomas' NHS Foundation Trust

Status: Enrolling

Conditions: Acute Myeloid Leukemia

Treatments: Drug: Venetoclax; Drug: Gilteritinib

Study type: Observational

Funder types: Other

Identifiers

NCT05312112

305432 (Other Identifier)

Details and patient eligibility

About

This project will collect data on patients with acute myeloid leukemia in the United Kingdom who were treated with two new targeted therapies during the coronavirus pandemic

Full description

Acute myeloid leukaemia (AML) is a blood cancer which in fit young adults is typically treated with intensive chemotherapy. While this is potentially curative, it is associated with significant side effects and the requirement for long hospital admissions. Infection is a major issue during AML treatment, as both the disease and the chemotherapy impair the immune system.

Early data suggested that COVID-19 is associated with a very high rate of death in AML patients undergoing intensive chemotherapy. Because of this, and the need for significant hospital resources to deliver intensive chemotherapy, the NHS made available two new, less intensive, targeted therapies for the treatment of AML during the COVID-19 pandemic - venetoclax and gilteritinib. The aim was to reduce mortality and healthcare resource use.

Many hundreds of patients across the UK have been treated with these two medications on the temporary access scheme. The research aims to collect de-identified data from treating patients to describe the outcomes of patients treated with these approaches, both in terms of the safety and effectiveness.

Enrollment: 1,000 estimated patients

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Venetoclax cohort Inclusion criteria

1. Newly diagnosed acute myeloid leukaemia
2. No prior therapies for AML, apart from hydroxyurea (or similar) for cytoreduction. Previous treatments for MDS or other conditions are allowed
3. Treated with venetoclax in combination with either azacitidine or LDAC No exclusion criteria

Gilteritinib/FLT3 cohort Inclusion criteria

1. Relapsed acute myeloid leukaemia, including molecular relapse
2. Treated with FLT3 inhibitor No exclusion criteria

Trial design

1,000 participants in 2 patient groups

Venetoclax

Description:

Venetoclax in newly diagnosed AML

Treatment:

Drug: Venetoclax

FLT3 inhibitors

Description:

FLT3 inhibitors including gilteritinib in relapsed AML

Treatment:

Drug: Gilteritinib