Real World Outcomes Using Novel Agents for AML in the UK

Last updated: February 28, 2023
Sponsor: Guy's and St Thomas' NHS Foundation Trust
Overall Status: Active - Recruiting

Phase

N/A

Condition

Leukemia

Acute Myeloid Leukemia

Platelet Disorders

Treatment

N/A

Clinical Study ID

NCT05312112
305432
305432
  • Ages > 16
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

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

Study Design

Total Participants: 1000
Study Start date:
May 01, 2022
Estimated Completion Date:
October 01, 2023

Study 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.

Connect with a study center

  • Guy's and St Thomas' NHS Foundation Trust

    London, SE1 9RT
    United Kingdom

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.