The AML19 Trial is an intensive chemotherapy trial for patients between 16 and 60 with AML and High Risk Myelodysplastic disease (please note High Risk MDS arm is now closed).

Phase 1

Conditions: Acute myeloid leukaemiaHigh Risk Myelodysplastic Syndrome
MedDRA version: 21.1Level: PTClassification code 10028533Term: Myelodysplastic syndromeSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version: 21.1Level: PTClassification code 10000880Term: Acute myeloid leukaemiaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]

Registration Number: EUCTR2014-002195-90-DK

Lead Sponsor: Cardiff University

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 3000

Inclusion Criteria

•They have one of the forms of CD33 positive (any level) favourable,
standard risk or unknown cytogenetics, de novo AML as defined by the
WHO Classification
• WHO performance status 0-2.
• They are considered suitable for intensive chemotherapy.
• Age 16 to 60 years of age, with the following caveats: o Patients over
60 are eligible if intensive therapy is considered a suitable option o
Patients must be =18 to be eligible to receive Midostaurin
• A negative pregnancy test within 2 weeks prior to trial entry in WOCBP
to be repeated throughout the trial prior to each course of protocol
treatment.
• Sexually mature males and females must agree to use an adequate and
medically accepted method of contraception throughout the study and
for 6 months following treatment (unless patient is female and received
Mylotarg- in which case it should be 7 months) if they or their sexual
partners are women of childbearing potential (WOCBP).
• Written informed consent. · Patients must have Serum Alanine
Aminotransferase (ALT) and Aspartate Aminotransferase (AST) =2.5
×ULN and bilirubin =2×ULN · For Midostaurin: Patients must have a FLT3
TKD or ITD mutation detected by the central laboratory in Cardiff
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 2900
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0

Exclusion Criteria

•Patients with APL, secondary AML, therapy-related AML, high risk
myelodysplastic syndrome with <20% bone marrow blasts, or de novo
AML with known adverse risk cytogenetics.
• Concurrent active malignancy requiring treatment.
• Patients who are pregnant or lactating.
• Known infection with Human Immunodeficiency Virus (HIV).
• Previous cytotoxic chemotherapy for AML. Note: Hydroxycarbamide, or
similar low-dose therapy, to control the white count prior to initiation of
intensive therapy is not an exclusion
• Blast transformation of chronic myeloid leukaemia (CML).
• The physician and patient consider that intensive therapy is not an
appropriate treatment option.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To compare overall survival in patient groups of differing risk status by assessing time from randomisation into particular arms of the study until death from any cause.;Secondary Objective: • Complete remission (CR or CRi) achievement after two courses of<br>induction, and reasons for failure (for induction questions)<br>• Duration of remission, relapse rates and deaths in first CR<br>• Toxicity, both haematological and non-haematological<br>• Supportive care requirements (and other aspects of health<br>economics)<br>• To assess quality of life in all patient groups.;Primary end point(s): Overall survival (OS);Timepoint(s) of evaluation of this end point: Protocol V9.0 requires 250 patients to be recruited over a 1-year period.<br>A 2-year follow up period will then begin. Patient data from recruitment<br>to protocol V9.0 will be used in addition with recruitment data from<br>previous protocol versions to ensure that all protocol questions are<br>answered.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): · Complete remission (CR or CRi) achievement after two courses of<br>induction and reasons for failure (for induction questions)<br>· Duration of remission, relapse rates and deaths in first CR<br>· Toxicity, both haematological and non-haematological<br>· Supportive care requirements (and other aspects of health economics)<br>· Quality of life for all new patients, and the now closed disease<br>monitoring randomisation and APL trial arm.;Timepoint(s) of evaluation of this end point: Protocol V9.0 requires 250 patients to be recruited over a 1-year period.<br>A 2-year follow up period will then begin. Patient data from recruitment<br>to protocol V9.0 will be used in addition with recruitment data from<br>previous protocol versions to ensure that all protocol questions are

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