AML 16
Trial overview
The AML16 Trial will evaluate several relevant therapeutic questions in Acute Myeloid Leukaemia (AML), as defined by the WHO, and High Risk Myelodysplastic Syndrome. The trial is primarily designed for patients over 60 years, but younger patients who may not be considered suitable for the concurrent MRC AML Trial for
younger patients may also enter.
Inclusion criteria
Patients who have one of the forms of acute myeloid leukaemia, except Acute Promyelocytic 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 greater than 10% marrow blasts (RAEB-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 AML15 trial.
— They have given written informed consent.
Exclusion criteria
- 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 excluding basal cell carcinoma.
— They are pregnant or lactating.
— They have Acute Promyelocytic Leukaemia.
— Patients with abnormal liver function tests exceeding twice the local upper
limit of normal are not eligible for the Mylotarg randomisations.
— Patients with a serum creatinine above the local upper limit of normal are not
eligible for the Clofarabine randomisations in either the intensive or the non-
intensive parts of the trial.
Contact details
AML Flow Chart
Other trials currently active for Acute Myeloid Leukaemia
Phase II study of the tolerability of adjunctive azacitidine in patients undergoing reduced intensity allogeneic stem cell transplantation for acute myeloid leukaemia and myelodysplasia.
Phase II study of the tolerability of adjunctive azacitidine in patients undergoing reduced intensity allogeneic stem cell transplantation for acute myeloid leukaemia and myelodysplasia.
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).
A pilot safety / tolerability study of Lenalidomide administered as monotherapy and in combination with standard chemotherapy for
Acute Myeloid Leukaemia / high-risk Myelodysplastic Syndrome with structural abnormalities of chromosome 5
Novartis Panobinostat Refractory AML
A Phase II Study of Oral Single Agent Panobinostat in Patients with Refractory de novo or secondary Acute Myelogenous Leukemia (AML)
Tags
disorders disease myeloid myelodysplastic syndrome acute myeloid leukaemia aml azacitidine myelodysplasia chemotherapy high risk myelodysplastic syndrome aml 17 high risk mds acute myelogenous leukemia (aml)