Real World Outcomes Using Novel Agents for AML in the UK

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-05-01

Study Completion Date

2023-10-01

Brief Summary

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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

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Detailed Description

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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.

Conditions

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Acute Myeloid Leukemia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Venetoclax

Venetoclax in newly diagnosed AML

Venetoclax

Intervention Type DRUG

Observational study of venetoclax in AML

FLT3 inhibitors

FLT3 inhibitors including gilteritinib in relapsed AML

Gilteritinib

Intervention Type DRUG

Observational study of gilteritinib in AML

Interventions

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Venetoclax

Observational study of venetoclax in AML

Intervention Type DRUG

Gilteritinib

Observational study of gilteritinib in AML

Intervention Type DRUG

Other Intervention Names

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Venclyxto Xospata

Eligibility Criteria

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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

1. Relapsed acute myeloid leukaemia, including molecular relapse

Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No