Real World Outcomes Using Novel Agents for AML in the UK

NCT05312112 | Unknown

• 1 other identifier: 305432
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

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

Conditions

Acute Myeloid Leukemia

Outcome Measures

Primary Outcomes (2)

• 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 (7)

• Response rate

  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

  1 year

• Relapse-free survival

  1 year

• Treatment toxicity 1

  During the first cycle of therapy (each cycle is 28 days although may be extended if recovery is delayed)

• Treatment toxicity 2

  During the first cycle of therapy (each cycle is 28 days although may be extended if recovery is delayed)

Study Arms (2)

Venetoclax

Venetoclax in newly diagnosed AML

Drug: Venetoclax

FLT3 inhibitors

FLT3 inhibitors including gilteritinib in relapsed AML

Drug: Gilteritinib

Interventions

Venetoclax DRUG

Observational study of venetoclax in AML

Also known as: Venclyxto

Venetoclax

Gilteritinib DRUG

Observational study of gilteritinib in AML

Also known as: Xospata

FLT3 inhibitors

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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

You may qualify if:

• 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

You may not qualify if:

• Relapsed acute myeloid leukaemia, including molecular relapse

Sponsors & Collaborators

• Guy's and St Thomas' NHS Foundation Trust: lead
• King's College London: collaborator

Study Sites (1)

Guy's and St Thomas' NHS Foundation Trust

London, SE1 9RT, United Kingdom

RECRUITING

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Interventions

venetoclax; gilteritinib

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Richard Dillon

  King's College London

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Richard Dillon

CONTACT

020 7188 257; richard.dillon@kcl.ac.uk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 9, 2022
• First Posted: April 5, 2022
• Study Start: May 1, 2022
• Primary Completion: October 1, 2023
• Study Completion: October 1, 2023
• Last Updated: March 2, 2023

Record last verified: 2023-02

Locations

GB (1)