A Trial for Older Patients with Acute Myeloid Leukaemia and High Risk Myelodysplastic Syndrome - AML18

Cardiff University0 sites2,000 target enrollmentMay 6, 2014

ConditionsAcute Myeloid LeukaemiaHigh Risk Myelodysplastic Syndrome MedDRA version: 20.0Level: SOCClassification code 10005329Term: Blood and lymphatic system disordersSystem Organ Class: 10005329 - Blood and lymphatic system disorders Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]

DrugsMylotarg LITAK Dacogen Vyxeos (daunorubicin/cytarabine)

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Acute Myeloid LeukaemiaHigh Risk Myelodysplastic Syndrome
Sponsor: Cardiff University
Enrollment: 2000
Status: Active, not recruiting
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

May 6, 2014

End Date

TBD

Last Updated

4 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

Cardiff University

Eligibility Criteria

Inclusion Criteria

•Patients are eligible for the AML18 trial if:
•They 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\). (NB patients with prior MDS (\>10% blasts, RAEB2\) who have received prior azacitidine are not eligible for the trial, but patients with \<10% who have failed a hypomethylating agent and developed AML may enter the trial)
•Patients should normally be over the age of 60, but patients under this age are eligible if they are not considered eligible for the MRC AML19 trial. Please contact the trial team for further information
•Patients entering the Vosaroxin/Decitabine arm must be over the age of 60 and have known adverse risk cytogenetics at entry
•They have given written informed consent
•Serum creatinine \= 1\.5 × ULN (upper limit of normal)
•Sexually mature males must agree to use an adequate and medically accepted method of contraception throughout the study if their sexual partners are women of child bearing potential (WOCBP). Men should be advised to not father a child while receiving trial treatment. Similarly women must agree to adequate contraceptive measures and avoid becoming pregnant while on protocol treatment. In both males and females these measures must be in place for at least 3 months following completion of Decitabine and at least 6 months after the last administration of Cladribine. The time period following treatment with Decitabine where it is safe to become pregnant is unknown. In the event of pregnancy at any point during the trial, the IMPs should be immediately stopped and the Trial Team should be contacted and pregnancy reporting procedures followed
•ECOG Performance Status of 0\-2
•Please note for the AC220 intervention: specific electrolyte and cardiac criteria (see page 29\) must be met. Only patients with a confirmed FLT3 mutation in the diagnostic sample are eligible for the AC220 randomisation.
•Are the trial subjects under 18? no

Exclusion Criteria

•Patients are not eligible for the AML18 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)
•They have a concurrent active malignancy excluding basal cell carcinoma
•They are pregnant or lactating
•They have Acute Promyelocytic Leukaemia
•Known infection with human immunodeficiency virus (HIV)
•Patients with prior cumulative anthracycline exposure (from prior treatment of a non AML cancer) of greater than 300 mg/m2 daunorubicin (or equivalent).
•History of myocardial infarction (MI), unstable angina, cerebrovascular accident, or transient ischemic attack (CVA/TIA) within 3 months before entry