None listed
Conditions
Brief summary
This study compares the safety and effectiveness of different types of chemotherapy to treat late stage acute myeloid leukaemia. Who is it for? You can join this study if you are aged 18 years or over and have been diagnosed with acute myeloid leukaemia, for which you have undergone two or three previously unsuccessful chemotherapy regimens. Trial details In this study, participants are randomly (by chance) divided into two groups. One group will receive chemotherapy with the drug, Elacytarabine. This will be administered intravenously (into the vein) continuously for 3 days every 3 weeks. The investigator wil decide how long it is beneficial for you to receive treatment.The other group will receive one of a number of other chemotherapy regimens used to treat leukaemia. The treatment administered will be selected by the treating doctor based on your condition. Participants will be regularly monitored in order to determine the safety and effectiveness of treatment.
Interventions
Elacytarabine continous infusion days 1-5, every 3 weeks,
dose 2000 mg/m2/d.
1-2 treatment courses should be administered for remission induction, and 1-2 courses for consolidation. Patients who benefit from the treatment may receive repeated courses
of study drug at the discretion of the investigator, even if remission is not attained.
Sponsors
Clavis Pharma ASA
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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
Outcome results
None listed