A Randomised Phase III Study of Elacytarabine vs. Investigator’sChoice in Patients with Late Stage Acute Myeloid Leukaemia

Phase 3

Recruiting

• Conditions: Relapsed / refractory AML; Cancer - Leukaemia - Acute leukaemia

• Registration Number: ACTRN12611000474954
• Lead Sponsor: Clavis Pharma ASA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-05-09
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 350

Inclusion Criteria

Patients with a confirmed diagnosis of AML according to WHO classification
(excluding acute promyelocytic leukaemia) who have received two or three
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.
- 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
- 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
- Patients younger than 65 years should have received previous treatment with
cytarabine
- 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

Exclusion Criteria

-Persistent clinically significant toxicities from previous chemotherapy
-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
- 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.
- Patients receiving any anti-leukaemic agents within the last 4 weeks. Hydroxyurea, however, is allowed for up to 12 hours prior to study treatment.
- Patients receiving any investigational treatment within the last 14 days

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Compare the efficacy, measured as overall survival (OS), of elacytarabine and<br>investigator's choice in patients with late stage AML[Up to 6 months after last patient included in the trial.]