The purpose of the study is to determine if treatment of older patients indicated with
untreated Acute Myeloid Leukemia (AML) who are not considered to be suitable for intensive
chemotherapy, can effectively be treated with Clofarabine.
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Locations near you
Unfortunately, there are no recruiting locations near you. Please check the list with all locations below.
Full eligibility criteria for NCT00924443
Ages eligible for Study
65 Years and older
Genders eligible for Study
Accepts Healthy Volunteers
Provide signed, written informed consent
Have untreated AML according to World Health Organization (WHO) classification
Male or post-menopausal female ≥ 65 years of age
Unsuitable for intensive chemotherapy
Be able to comply with study procedures and follow-up examination
Male patient who are fertile agree to use and effective barrier method of birth control to avoid pregnancies
Have adequate liver and renal function as indicated by certain laboratory values
Received previous treatment with clofarabine
Are receiving other chemotherapy or corticosteroids (low-dose corticosteroid for pre-medication purposes are allowed)
Have received prior treatment for leukemia. Growth factor, cytokine support, leukopheresis or hydroxyurea will be allowed but must be discontinued at least 24 hours prior to start of treatment with clofarabine
Have a psychiatric disorder that would interfere with consent, study participation, or follow-up
Have an active, uncontrolled systemic infection
Are currently participating in other investigational drug studies or having received other investigational drugs within the previous 30 days
Have symptomatic central nervous system (CNS) involvement
Blast transformation of chronic myeloid leukemia or acute promyelocytic leukemia
All locations for NCT00924443
United Kingdom (12)
Belfast, Northern Ireland, United Kingdom
Aberdeen, United Kingdom
Birmingham, United Kingdom
Cardiff, United Kingdom
Edinburgh, United Kingdom
Leicester, United Kingdom
Liverpool, United Kingdom
London, United Kingdom
Manchester, United Kingdom
Nottingham, United Kingdom
Somerset, United Kingdom
Taunton, United Kingdom
Trial results for NCT00924443
Participant Flow: Overall Study
66 / 69
Completed / Started
Serious Adverse Events
40 / 66
Affected / At Risk
Other Adverse Events
66 / 66
Affected / At Risk
View full eligibility
Tris trial is registered with FDA with number: NCT00924443. The sponsor of the trial is Genzyme, a Sanofi Company and it is looking for 69 volunteers for the current phase.
Official trial title: A Phase II Trial of Clofarabine in Older Patients With Acute Myeloid Leukemia for Whom Intensive Chemotherapy is Not Considered Suitable
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