A Study of Clofarabine in Older Patients With Acute Myeloid Leukemia (AML) for Whom Chemotherapy Is Not Suitable
NCT ID: NCT00924443
Last Updated: 2015-04-01
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
69 participants
INTERVENTIONAL
2004-06-30
2008-03-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Study of Clofarabine for Older Patients With Newly Diagnosed Acute Myelogenous Leukemia (AML) (CLASSIC II)
NCT00373529
A Study of Clofarabine and Cytarabine for Older Patients With Relapsed or Refractory Acute Myelogenous Leukemia (AML)(CLASSIC I)
NCT00317642
The Role of Maintenance Oral Clofarabine in Older Adults With Acute Myeloid Leukemia
NCT01065545
Phase II Study of Clofarabine in Adult Patients With Refractory or Relapsed Acute Myelogenous Leukemia
NCT00044889
Plerixafor and Clofarabine in Frontline Treatment of Elderly Patients With Acute Myelogenous Leukemia (AML)
NCT01160354
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Clofarabine
Clofarabine 30 mg/m\^2/day intravenously over 1 hour for 5 days every 28 to 42 days (one cycle), then 20mg/m\^2/day intravenously over 1 hour for 5 days every 29 to 43 days for the second and subsequent cycles, up to a maximum of 3 cycles.
clofarabine
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
clofarabine
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
Exclusion Criteria
* 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
65 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Bioenvision
INDUSTRY
Genzyme, a Sanofi Company
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Medical Monitor
Role: STUDY_DIRECTOR
Genzyme, a Sanofi Company
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Dublin, , Ireland
Bologna, , Italy
Rome, , Italy
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
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
BIOV-121
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.