Acute Myeloid Leukemia
Conditions
Keywords
Acute Myeloid Leukaemia (AML)
Brief summary
A study to assess the safety and tolerability of AZD1152 in combination with low dose cytosine arabinoside (LDAC) in patients with acute myeloid leukaemia (AML). The first three patients to complete a 28 day cycle in the cohort, before the second three patients start treatment.
Interventions
DRUGAZD1152
Variable dose via a 7-day continuous infusion
DRUGLDAC (low dose cytosine arabinoside)
20 mg subcutaneous injection given twice daily
Sponsors
AstraZeneca
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Newly diagnosed patient. * Provision of written informed consent. * De Novo (primary) or Secondary AML. * Not eligible for intensive induction chemotherapy because of medical, social or psychological reasons.
Exclusion criteria
* Patients with AML of FAB M3 classification Acute Promyelocytic Leukaemia (APL). * Patients with blast crisis of chronic myeloid leukaemia. * Persistent, chronic, clinically significant toxicities from any prior anti- cancer therapy greater than CTCAE Grade 1 (except alopecia).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety as measured by Adverse Events, Vital Signs, ECGs, Clinical Chemistry, Haematology and Urinalysis | Information on these will be collected from the time of informed consent is signed, throughout the study. |
Secondary
| Measure | Time frame |
|---|---|
| Assessment of the pharmacokinetics of AZD1152, its active moiety AZD1152 hQPA, and LDAC. | During the first treatment cycle for AZD1152, pre-dose and Days 2, 3,7, 8, 9, 10, 15 and 22. For LDAC, Days 7 and 10. |
Countries
France, United States
Outcome results
None listed