AML18 Pilot

Phase 1

• Conditions: Acute Myeloid Leukaemia and High Risk Myelodysplastic Syndrome; MedDRA version: 14.1 Level: SOC Classification code 10005329 Term: Blood and lymphatic system disorders System Organ Class: 10005329 - Blood and lymphatic system disorders

• Registration Number: EUCTR2010-021444-18-GB
• Lead Sponsor: Cardiff University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-10-08
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 90

Inclusion Criteria

1) They have one of the forms of AML, except Acute Promyelocytic Leukaemia as defined by the WHO Classifcation - this can be any type of de novo or secondary AML - or high risk MDS, defined as greater than 10% marrow blasts.
2) Serum creatinine = 1.5xULN.
3) White cell count of <30x10^9/L at diagnosis (for Plerixafor option only).
4) Serum potassium, magnesium and calcium levels should be at least within institutional normal limits.
5) Total serum bilirubin = 1.5xULN and serum aspartate transaminase and/or alanine transaminase = 2.5xULN
6) 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)
7) Over 60 years of age
8) Provided written informed consent
Are the trial subjects under 18? no
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 0
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 80

Exclusion Criteria

1)They have previously received cytotoxic chemotherapy for AML (hydroxycarbimide, or similar low-dose therapy, to control the white count prior to initiation of intensive therapy is not an exclusion)
2) They are in blast transformation of chronic myeloid leukaemia (CML)
3) They have a concurrent active malignancy excluding basal cell carcinoma
4) They are pregnant or lactating
5) They have Acute Promyelocytic Leukaemia
6) Known infection with human immunodeficiency virus (HIV)
7) Patients are not eligible for the AC220 option if they have:
-Uncontrolled or significant cardiovascular disease including:
-A myocardial infarction within 12 months
-Uncontrolled angina within 6 months
-Current, or history of, congestive heart failure New York Heart Association (NYHA) class 3 or 4, unless an echocardiogram or Multiple Gated Acquisition Scan performed either within 1 month prior to study screening or during screening results in a left ventricular ejection fraction that is =45% (or institutional lower limit of normal value)
-Diagnosed or suspected congenital long QT syndrome. Any history of clinically significant ventricular arrhythmias (such as ventricular tachycardia, ventricular fibrillation, or torsades de pointes); any history of arrhythmia will be discussed with the Sponsor's Medical Monitor prior to patient's entry into the study.
-Prolonged QTcF interval on pre-entry ECG (=450ms)
-Any history of second or third degree heart block (may be eligible if the patient currently has a pacemaker)
-Heart rate <50/min on pre-entry ECG
-Uncontrolled hypertension
-Obligate need for a cardiac pacemaker
-Complete left bundle branch block
-Atrial fibrillation

Study & Design

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