AML 17

Trial overview

The AML 17 trial has two distinct parts:

i.For patients with acute myeloid leukaemia (AML), (other than acute promyelocytic leukaemia) and High Risk Myelodysplasia, as defined by the WHO Classification (2001) (Appendix A, protocol).

ii.For adults with acute promyelocytic leukaemia (APL).

 

Inclusion criteria

FOR NON-APL AML HIGH RISK MDS PATIENTS:

—They have one of the forms of acute myeloid leukaemia as defined by the WHO Classification (Appendix A, protocol) — this can be any type of de novo or secondary AML or high risk Myelodysplastic Syndrome (defined as >10% bone marrow blasts).

—Adult patients with acute promyelocytic leukaemia (APL) are eligible and should be entered into the randomisations specifically for APL (see Section 19, protocol).  

—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 be eligible for the Mylotarg randomisation.
 
-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.

FOR APL AML 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.

 

Exclusion criteria

NON APL AML HIGH RISK MDS PATIENTS:

—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).

—They have a concurrent active malignancy.

—They are pregnant or lactating or taking adequate contraception measures.

—The physician and patient consider that intensive therapy is not an appropriate treatment option. (Such patients should be considered for the NCRI AML16 trial for older or less fit patients).

 

APL AML 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.

Contact details

Prinicipal Investigator

Prof Bowen

Tel 01132068481

Email david.bowen@leedsth.nhs.uk

Research Nurse

Catherine Levy

Tel 01132068577

Email catherine.levy@leedsth.nhs.uk



Other trials currently active for Myelodysplastic Syndromes

MDS-Bio1

Molecular and functional characterisation of bone marrow function in normal subjects, myelodysplastic syndromes (MDS) and secondary disorders of haematopoiesis

REDDS

Red blood cell transfusion thresholds and QoL in myelodysplastic syndromes: a pilot, feasibility study


Tags

acute myeloid leukaemia aml high risk mds non apl