A PHASE II TRIAL OF CLOFARABINE IN OLDER PATIENTS WITH ACUTE MYELOID LEUKAEMIA FOR WHOM INTENSIVE CHEMOTHERAPY IS NOT CONSIDERED SUITABLE

Recruitment & Eligibility

Status: ot Recruiting

Sex: Not specified

Target Recruitment: 65

Inclusion Criteria

1.Patients must have untreated AML as defined by the WHO classification (Appendix I)
2.Patients must provide written informed consent.
3.Male or Post-Menopausal female patients = 65 years of age and unsuitable for intensive chemotherapy
4.Male patients who are fertile agree to use an effective barrier method of birth control (i.e., latex condom, diaphragm, cervical cap, etc) to avoid pregnancy.
5.Patients must be able to comply with study procedures and follow-up examinations.
6.Patients must have adequate organ function as indicated by the following laboratory values, obtained within 7 days prior to enrolment.

Inclusion Laboratory Values
ParameterRequired Value International Standard (IS units)
Serum Bilirubin< 1.5 x ULN
AST and ALT< 2 x ULN
Creatinine< 1.7g/dL
Prothrombin Time< 1.5 x control
ULN = Institutional Upper Limit of Normal.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Patients who meet any of the following criteria will be excluded from study admission:
1.Patients who have an active, uncontrolled systemic infection considered opportunistic, life threatening or clinically significant at the time of treatment.
2.Patients who have a psychiatric disorder(s) that would interfere with consent, study participation or follow-up.
3.Patients who are receiving other chemotherapy or corticosteroids (unless the latter is administered at a low dose for pre-medication purposes or for the treatment of chronic conditions – e.g., rheumatoid arthritis).
4.Patients who have received prior treatment for leukaemia. Patients who have received growth factor, cytokine support, leukopheresis or, hydroxyurea, will be allowed into the study but must discontinue treatment at least 24 hours prior to beginning treatment with clofarabine.
5.Patients who have any other severe concurrent disease (severe Coronary Artery Disease (CAD), significant neurological disorder, uncontrolled diabetes, etc), which, in the judgment of the investigator, would make the patient inappropriate for entry into this study.
6.Patients who have symptomatic Central Nervous System (CNS) involvement.
7.Patients who have previously received clofarabine.
8.Patients who are currently participating in other investigational drug studies or having received other investigational drugs within the previous 30 days.
9.Blast transformation of chronic myeloid leukaemia or acute promyelocytic leukaemia.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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