Acute myeloid leukaemia Cancer Myeloid leukaemia
Conditions
Interventions
The calculation of dosage is based on the patients body surface area. The dose of DaunoXome® is fixed for all cohorts at 60 mg/m^2. DaunoXome® is given intravenously over 2 hours and start 4 hours af
Sponsors
University of Birmingham (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Diagnosis of acute myelogenous leukaemia (AML) 2. Patients must be in first relapse within 12 months of initial diagnosis or refractory to induction therapy or be in second or subsequent relapse 3. Patients with refractory AML following induction must be greater than 20% blasts in the bone marrow 4. Age must be between 6 months to less than 18 years old, either sex 5. Karnofsky or Lansky score of greater than 50 6. Patients of childbearing potential must have a negative pregnancy test and agree to use an effective birth control or evidence of post-menopausal status. Post-menopausal status is defined as either radiation-induced oophorectomy with last menses greater than 1 year ago; chemotherapy induced menopause with 1 year interval since last menses. 7. Normal renal function 8. Normal hepatic function 9. Cardiac function defined as: shortening fraction of greater than 29% by echocardiogram left ventricular ejection fraction (LVEF) greater than 58%
Exclusion criteria
Exclusion criteria: 1. First relapse greater than 1 year from their initial diagnosis of AML 2. Patients whose previous daunorubicin equivalent exposure equals or exceeds 450 mg/m^2 3. Isolated extramedullary leukaemia 4. Symptomatic central nervous system (CNS) involvement 5. Any evidence of severe or uncontrolled systemic conditions 6. Concurrent treatment or administration of any other experimental drug or with any other cancer therapy 7. Patients unable to be regularly followed up 8. Patient with expected non-compliance to toxicity management guidelines
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To establish the maximum tolerated dose of clofarabine (Clolar®) when used in combination with DaunoXome®. The maximum tolerated dose will be defined by the number of dose-limiting toxicities during cycle 1 of therapy. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. To characterise the safety and tolerability of the combination of clofarabine (Clolar®) and DaunoXome® including identification of the dose limiting toxicities 2. To document the overall response rate, including complete remission (CR), complete remission with incomplete blood count recovery (CRi) and partial remission (PR) in this population 3. To describe the durability fo response and follow up of these patients, including the number of patients that undergo stem-cell transplant after re-induction with clofarabine (Clolar®) and DaunoXome® Measured as follows: 1. The nature, incidence and severity of the adverse events, collected throughout cycle 1 of therapy 2. Responses measured by bone marrow assessment between day 21 and 42 post first dose of clofarabine (Clolar®) and DaunoXome® | — |
Countries
United Kingdom
Outcome results
None listed