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).
- Conditions
- Acute myeloid leukaemiaHigh Risk Myelodysplastic Syndrome (trial arm for this patient group is now closed awaiting final analysis)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-GB
- Lead Sponsor
- Cardiff University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- A
- Sex
- All
- Target Recruitment
- 250
•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? yes
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 240
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0
•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
- Secondary Outcome Measures
Name Time Method