Real World Outcomes Using Novel Agents for AML in the UK
- Registration Number
- NCT05312112
- Lead Sponsor
- Guy's and St Thomas' NHS Foundation Trust
- Brief 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
- Detailed 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 & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 1000
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Venetoclax Venetoclax Venetoclax in newly diagnosed AML FLT3 inhibitors Gilteritinib FLT3 inhibitors including gilteritinib in relapsed AML
- Primary Outcome Measures
Name Time Method Overall survival 1 year Overall survival measured from time of treatment initiation
Early death rate Day 60 after starting treatment Early death rate measured at day 60 after treatment initiation
- Secondary Outcome Measures
Name Time Method Relapse-free survival 1 year RFS as defined by ELN
Response rate After 2 cycles of therapy (each cycle is 28 days although may be extended if recovery is delayed) Response rate as defined by ELN 2017
Incidence of relapse in patients achieving remission 1 year Relapse incidence measured from the time of achieving remission
Treatment toxicity 1 During the first cycle of therapy (each cycle is 28 days although may be extended if recovery is delayed) Number of days in hospital and number of days of intensive care
Treatment toxicity 2 During the first cycle of therapy (each cycle is 28 days although may be extended if recovery is delayed) Duration of neutropenia and thrombocytopenia
Treatment toxicity 3 During the first cycle of therapy (each cycle is 28 days although may be extended if recovery is delayed) Number of blood and platelet transfusions
Comparison of survival between patient sub-groups 1 year Overall survival compared between disease groups
Trial Locations
- Locations (1)
Guy's and St Thomas' NHS Foundation Trust
🇬🇧London, United Kingdom