Real World Outcomes Using Novel Agents for AML in the UK | NCT05312112

Studies
Real World Outcomes Using Novel Agents for AML in the UK

NCT05312112

Sponsor

Guy's and St Thomas' NHS Foundation Trust

Status

Unknown status

Last Update Posted

Mar 2, 2023Actual

Enrollment

1,000Estimated

Phase

Not provided

Conditions

Acute Myeloid Leukemia

Interventions

Venetoclax
Gilteritinib

Countries

United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
305432	Other Identifier	IRAS

Status Module

Record Verification Date

Feb 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 1, 2022Actual

Primary Completion Date

Oct 1, 2023Estimated

Completion Date

Oct 1, 2023Estimated

First Submitted Date

Mar 9, 2022

First Submission Date that Met QC Criteria

Mar 28, 2022

First Posted Date

Apr 5, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 28, 2023

Last Update Posted Date

Mar 2, 2023Actual

Name	Class
King's College London	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1,000Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Venetoclax		Venetoclax in newly diagnosed AML	Drug: Venetoclax
FLT3 inhibitors		FLT3 inhibitors including gilteritinib in relapsed AML	Drug: Gilteritinib

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Venetoclax	Drug	Observational study of venetoclax in AML	Venetoclax

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Overall survival	Overall survival measured from time of treatment initiation	1 year
Early death rate	Early death rate measured at day 60 after treatment initiation	Day 60 after starting treatment

Secondary Outcomes

Measure	Description	Time Frame
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)
Incidence of relapse in patients achieving remission

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Venetoclax cohort Inclusion criteria

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

Gilteritinib/FLT3 cohort Inclusion criteria

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

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

16 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

The NHS criteria for access to venetoclax was that a patient was fit for IC and was:

Aged >16y with NPM1 mutation without FLT3 internal tandem duplication (ITD)
Aged >50y with NPM1, IDH1 or IDH2 mutations (regardless of FLT3 status)
Patients aged >60y without favourable-risk cytogenetics

Gilteritinib was made available to all patients aged >16y with relapse or refractory FLT3 mutated AML. Other FLT3 inhibitors are available to patients through various access schemes

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Richard Dillon	Contact	020 7188 257		richard.dillon@kcl.ac.uk

Overall Officials

Name	Affiliation	Role
Richard Dillon	King's College London	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Guy's and St Thomas' NHS Foundation Trust	Recruiting	London		SE1 9RT	United Kingdom

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D015470	Leukemia, Myeloid, Acute

Ancestor Terms

ID	Term
D007951	Leukemia, Myeloid
D007938	Leukemia
D009370	Neoplasms by Histologic Type
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

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