ational Cancer Research Institute acute myeloid leukaemia and high risk MDS trial 16. A trial for older patients with acute myeloid leukaemia and high risk myelodysplastic syndrome (MDS).

Phase 3

Completed

• Conditions: Acute Myloid Leukaemia (AML) and High Risk Myelodysplastic Syndrome (MDS).; Cancer; Leukaemia

• Registration Number: ISRCTN11036523
• Lead Sponsor: Cardiff University (UK)

Brief Summary

2013 Results article in http://www.ncbi.nlm.nih.gov/pubmed/23838349 results 2013 Results article in http://www.ncbi.nlm.nih.gov/pubmed/24062403 results

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2005-10-11
• Study Completion: 2017-04-03
• Last Update Posted: 7 February 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 2247

Inclusion Criteria

1. They have one of the forms of acute myeloid leukaemia, except acute promyelocytic leukaemia, as defined by the World Health Organisation (WHO) Classification - this can be any type of de novo or secondary AML - or high risk Myelodysplastic Syndrome, defined as greater than 10% marrow blasts (RAEB-2)
2. They should normally be over the age of 60, but patients under this age are eligible if they are not considered fit for the MRC AML 15 trial
3. They have given written informed consent

Exclusion Criteria

1. Patients have previously received cytotoxic chemotherapy for AML. (Hydroxyurea, or similar low-dose therapy, to control the white count prior to initiation of intensive therapy is not an exclusion.)
2. They are in blast transformation of chronic myeloid leukaemia (CML)
3. They have a concurrent active malignancy
4. They are pregnant or lactating
5. Patients with abnormal liver function tests exceeding twice the local upper limit of normal are not eligible for the Mylotarg randomisations
6. Patients with Acute Promyelocytic Leukaemia

Study & Design

• Study Type: Interventional
• Study Design: Not specified