A Phase II Trial of Clofarabine in Older Patients with Acute Myeloid Leukaemia for Whom Intensive Chemotherapy is Not Considered Suitable

• Conditions: Acute Myeloid Leukemia; MedDRA version: 14.1Level: PTClassification code 10000880Term: Acute myeloid leukaemiaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2004-004527-35-IT
• Lead Sponsor: Bioenvision Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-07-20
• Last Update Posted: 17 December 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. Patients must have untreated AML as defined by the WHO classification 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 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. Serum Bilirubin < 1.5 x ULN AST and ALT < 2 x ULN Creatinine < 1.5 x ULN Prothrombin Time < 1.5 x control ULN = Institutional Upper Limit of Normal.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary end point(s): Tumor response, toxicity;Main Objective: To determine the overall response (OR) rate with clofarabine in older patients with untreated AML, for whom intensive chemotherapy is not considered suitable. 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: To document in the study population: the rate of CR(s) CRi(s)and PR(s); time to event parameters including duration of complete remission and overall survival (OS) and time to complete remission for each patient up to 24 months after last dose of clofarabine; safety profile and tolerability of clofarabine for this population and dosing regimen; the pharmacokinetic profile and intracellular triphosphate levels of clofarabine in the study population.