Real World Outcomes Using Novel Agents for AML in the UK

Acute Myeloid Leukemia Clinical Trial

Official title:

Real World Outcomes Using Novel Agents for Acute Myeloid Leukaemia in the United Kingdom

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05312112
• Other study ID #: 305432
• Secondary ID: 305432
• Status: Recruiting
• Start date: May 1, 2022
• Est. completion date: October 1, 2023

Study information

• Verified date: February 2023
• Source: Guy's and St Thomas' NHS Foundation Trust
• Contact: Richard Dillon
• Phone: 020 7188 257
• Email: richard.dillon[@]kcl.ac.uk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: October 1, 2023
• Est. primary completion date: October 1, 2023
• Gender: All
• Age group: 16 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Myeloid Leukemia
• Leukemia
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute

Intervention

Drug:
• Venetoclax
Observational study of venetoclax in AML
• Gilteritinib
Observational study of gilteritinib in AML

Locations

Country	Name	City	State
United Kingdom	Guy's and St Thomas' NHS Foundation Trust	London

Sponsors (2)

Lead Sponsor	Collaborator
Guy's and St Thomas' NHS Foundation Trust	King's College London

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival	Overall survival measured from time of treatment initiation	1 year
Primary	Early death rate	Early death rate measured at day 60 after treatment initiation	Day 60 after starting treatment
Secondary	Response rate	Response rate as defined by ELN 2017	After 2 cycles of therapy (each cycle is 28 days although may be extended if recovery is delayed)
Secondary	Incidence of relapse in patients achieving remission	Relapse incidence measured from the time of achieving remission	1 year
Secondary	Relapse-free survival	RFS as defined by ELN	1 year
Secondary	Treatment toxicity 1	Number of days in hospital and number of days of intensive care	During the first cycle of therapy (each cycle is 28 days although may be extended if recovery is delayed)
Secondary	Treatment toxicity 2	Duration of neutropenia and thrombocytopenia	During the first cycle of therapy (each cycle is 28 days although may be extended if recovery is delayed)
Secondary	Treatment toxicity 3	Number of blood and platelet transfusions	During the first cycle of therapy (each cycle is 28 days although may be extended if recovery is delayed)
Secondary	Comparison of survival between patient sub-groups	Overall survival compared between disease groups	1 year