Study of Elacytarabine Versus Investigator's Choice in Patients With Late Stage Acute Myeloid Leukaemia

Phase 1

Conditions: ate Stage Acute Myeloid Leukaemia
MedDRA version: 14.0 Level: LLT Classification code 10066764 Term: Acute myeloid leukaemia progression System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Therapeutic area: Diseases [C] - Cancer [C04]

Registration Number: EUCTR2009-014445-80-GB

Lead Sponsor: Clavis Pharma

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: Not specified

Target Recruitment: 380

Inclusion Criteria

1.Patients must be 18 years of age or older
2.Patients with a confirmed diagnosis of AML according to WHO classification (excluding acute promyelocytic leukaemia) who have received 2 or 3 induction/re-induction regimen or patients of age = 65 with adverse cytogenetic (see appendix 5 for complete list) who have received 1-3 previous induction/re-induction regimens. One of the (re-)induction regimens could be stem cell transplantation (SCT) for achievement of remission. Maintenance and consolidation (including SCT) may have been given, but are not counted as previous regimens.
3.Patient’s bone marrow aspirates and/or biopsies must contain > 5 % leukaemic blast cells or patient must have biopsy-proven extramedullary AML, or patient’s peripheral blood shows occurrence of leukaemic blast cells
4.Patients must
a.have never attained CR or CRi (primary refractory), or
b.have failed initial induction therapy, and have attained CR or CRi after salvage therapy(ies), and then relapsed within < 6 months, or
c.have attained CR or CRi after initial induction therapy and relapsed within <12 months, and failed to respond to salvage therapy(ies), or
d.have relapsed after the latest CR or CRi within < 6 months
5.Patients younger than 65 years should have received previous treatment with cytarabine
6.Patients must have recovered from previous bone marrow and/or stem cell transplantation to a stage that the patient can tolerate the study treatment. There is no restriction on number of regimens or type of treatment administered for maintenance or consolidation during previous stages of the disease
7.Patients must have ECOG performance status (PS) of 0 – 2
8.Women of child-bearing potential must have a negative serum or urine pregnancy test within 2 weeks prior to treatment start
9.Male and female patients must use acceptable contraceptive methods for the duration of time on study, and males also for 3 months after the last elacytarabine dose
10.Patients must be capable of understanding and complying with protocol requirements, and must be able and willing to sign a written informed consent form

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 270
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 110

Exclusion Criteria

1.A history of allergic reactions to egg. A history of allergic reactions of CTCAE grade 3 or 4 to cytarabine
2.Persistent clinically significant toxicities from previous chemotherapy
3.A cancer history that, according to the investigator, might confound the assessment of the study endpoints
4.Known positive status for human immunodeficiency virus (HIV)
5.Pregnant and nursing patients
6.Uncontrolled intercurrent illness including, but not limited to, uncontrolled infection, or psychiatric illness/social situations that would limit compliance with study requirements
7.Impairment of hepatic or renal function to such an extent that the patient, in the opinion of the investigator, will be exposed to an excessive risk if entered into this clinical study
8.Active heart disease including myocardial infarction within previous 3 months, symptomatic coronary artery disease, arrhythmias not controlled by medication, or uncontrolled congestive heart failure. Any NYHA grade 3 or 4
9.Applicable only for patients for whom an anthracycline is part of the selected control treatment:
Left ventricular ejection fraction (LVEF) must be = 45 % as measured by MUGA scan or 2D ECHO within 14 days prior to start of therapy. Either method is acceptable for measuring LVEF
10.Applicable only for patients for whom an anthracycline is part of the selected control treatment:
The patient should tolerate minimum one course of anthracycline containing therapy.
11.Patients receiving any anti-leukaemic agents within the last 3 weeks. Hydroxyurea, however, is allowed for up to 12 hours prior to study treatment.
12.Patients receiving any investigational treatment within the last 14 days
13.Any medical condition which in the opinion of the investigator places the patient at an unacceptably high risk for toxicities

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> Secondary Objective: Compare response rate and duration of response of elacytarabine and investigator’s choice in patients with late stage AML<br> <br> Compare the safety profile of elacytarabine with investigator’s choice<br> <br> Characterize exposure-response relationships for measures of effectiveness and toxicity.<br> ;<br> Main Objective: Compare the efficacy, measured as overall survival (OS), of elacytarabine and<br> investigator’s choice in patients with late stage AML<br> ;Primary end point(s): Number of deaths from any cause;Timepoint(s) of evaluation of this end point: Survival (Follow-up visit): For safety: 30 – 40 d after the last dose. For relapse and survival: monthly

Secondary Outcome Measures

Name	Time	Method

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