AML 17: Working Parties on Leukaemia in Adults and Children Trial in Acute Myeloid Leukaemia or High Risk Myelodysplastic Syndrome 17

Active, not recruiting

• Conditions: Acute Myeloid Leukaemia and High Risk Myelodysplastic Syndrome; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2007-003798-16-IE
• Lead Sponsor: Cardiff University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-10-13
• Last Update Posted: 7 October 2014

Recruitment & Eligibility

• Status: Not Recruiting
• Sex: All
• Target Recruitment: 2800

Inclusion Criteria

Inclusion Criteria for Non APL Leukaemia
Patients:
- They have one of the forms of acute myeloid leukaemia as defined by the WHO Classification (Appendix A) — this can be any type of de novo or secondary AML or high risk Myelodysplastic Syndrome (defined as >10% bone marrow blasts).
- Patients with acute promyelocytic leukaemia (APL) are eligible and should be entered into the randomisations specifically for APL (see Section 19).
- They are considered suitable for intensive chemotherapy.
- They should normally be under the age of 60, but patients over this age are eligible if intensive therapy is considered a suitable option.
- Patients must have liver function tests within twice the upper limit of the normal local range to receive Mylotarg in course 2 for the Core Binding Factor Leukaemia subset.
- Women of child-bearing potential (ie women who are pre-menopausal or not surgically sterile) must use acceptable contraceptive methods (abstinence. Intrauterine device (IUD) and must have a negative pregnancy test within 2 weeks of trial entry. Pregnant or nursing patients are excluded. Sexually active men must also use acceptable contraceptive methods
- They have given written informed consent.

Inclusion Criteria for APL Patients:
- Signed written informed consent
- Clinical diagnosis of APL and subsequently confirmed to have PML-RARA fusion
- Age > 15 years
- WHO performance status 0-2
- Serum total bilirubin < 2.0 mg/dL (=51 umol/L)
- Serum creatinine < 3.0 mg/dL (< 260 µmol/L)
- Women of child-bearing potential (ie women who are pre-menopausal or not surgically sterile) must use acceptable contraceptive methods (abstinence. Intrauterine device (IUD) and must have a negative pregnancy test within 2 weeks of trial entry. Pregnant or nursing patients are excluded. Sexually active men must also use acceptable contraceptive methods.
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 2800
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Patients are not eligible for the AML17 trial if:
- They have previously received cytotoxic chemotherapy for AML. [Hydroxycarbamide, or similar low-dose therapy, to control the white count prior to initiation of intensive therapy is not an exclusion.]
- They are in blast transformation of chronic myeloid leukaemia (CML).
- Have a LV ejection fraction of <45% (such patients can be placed on to the D(60)A arm
- They have a concurrent active malignancy.
- They are pregnant or lactating.
-The physician and patient consider that intensive therapy is not an appropriate treatment option.

Exclusion criteria for APL patients:
- Age < 16
- Active malignancy at time of study entry
- Lack of subsequent diagnostic confirmation of PML-RARA fusion at molecular level
- Significant arrhythmias, ECG abnormalities or neuropathy
- Cardiac contraindications for intensive chemotherapy (L-VEF <50%)
- Uncontrolled, life-threatening infections.
- Severe uncontrolled pulmonary or cardiac disease.
- Pregnant or lactating.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified