Acute Myeloid Leukaemia MedDRA version: 7.1 Level: LLT Classification code 10000880
Conditions
Interventions
Product Name: Clofarabine
Product Code: FP028
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: Clofarabine
CAS Number: NA
Sponsors
Bioenvision Limited
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients must have untreated AML as defined by the WHO classification (Appendix I) 2. Patients must provide written informed consent. 3. Male or Post-Menopausal female patients = 65 years of age and unsuitable for intensive chemotherapy 4. Male patients who are fertile agree to use an effective barrier method of birth control (i.e., latex condom, diaphragm, cervical cap, etc) to avoid pregnancy. 5. Patients must be able to comply with study procedures and follow-up examinations. 6. Patients must have adequate organ function as indicated by the following laboratory values, obtained within 7 days prior to enrolment. Inclusion Laboratory Values Parameter Required Value International Standard (IS units) Serum Bilirubin =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Patients who meet any of the following criteria will be excluded from study admission: 1. Patients who have an active, uncontrolled systemic infection considered opportunistic, life threatening or clinically significant at the time of treatment. 2. Patients who have a psychiatric disorder(s) that would interfere with consent, study participation or follow-up. 3. Patients who are receiving other chemotherapy or corticosteroids (unless the latter is administered at a low dose for pre-medication purposes or for the treatment of chronic conditions – e.g., rheumatoid arthritis). 4. Patients who have received prior treatment for leukaemia. Patients who have received growth factor, cytokine support, leukopheresis or, hydroxyurea, will be allowed into the study but must discontinue treatment at least 24 hours prior to beginning treatment with clofarabine. 5. Patients who have any other severe concurrent disease (severe Coronary Artery Disease (CAD), significant neurological disorder, uncontrolled diabetes, etc), which, in the judgment of the investigator, would make the patient inappropriate for entry into this study. 6. Patients who have symptomatic Central Nervous System (CNS) involvement. 7. Patients who have previously received clofarabine. 8. Patients who are currently participating in other investigational drug studies or having received other investigational drugs within the previous 30 days. 9. Blast transformation of chronic myeloid leukaemia or acute promyelocytic leukaemia.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the overall response (OR) rate of older patients with untreated AML, for whom intensive chemotherapy is not considered suitable, when given clofarabine at the study dose schedule. The OR rate is defined as the sum of the number of patients in the study population with complete remission (CR); complete remission with incomplete blood count recovery (CRi); and partial remission (PR) divided by the total number of patients in the study population. ; Secondary Objective: 1. To document the rate of CR(s) in the study population. 2. To document the rate of CRi(s) in the study population. 3. To document the rate of PR(s) in the study population. 4. To document time to event parameters including duration of remission and overall survival (OS) and time to remission. 5. To document the safety profile and tolerability of clofarabine for this population and dosing regimen. 6. To determine the pharmacokinetic profile and intracellular triphosphate levels of clofarabine in the study population. ; Primary end point(s): The Primary Efficacy Endpoint is: The overall response (OR) rate will be determined by assessment of morphology and blast count from bone marrow aspirates and peripheral blood performed prior to first dose and end of treatment. The OR rate will be defined as the sum of the number of patients in the study population with a CR, CRi or PR divided by the number of patients in the study population. Secondary Efficacy Endpoints are: ·The CR rate will be determined by dividing the number of patients in the study population with a CR by the total number of patients in the study population. ·The CRi rate will be determined by dividing the number of patients in the study population with a CRi by the total number of patients in the study population. | — |
Countries
Ireland, Italy
Outcome results
None listed