Acute Myelogenous Leukemia
Conditions
Keywords
CLO221, clolar
Brief summary
Clofarabine (injection) is approved by the Food and Drug Administration (FDA) for the treatment of pediatric patients 1 to 21 years old with relapsed acute lymphoblastic leukemia (ALL) who have had at least 2 prior treatment regimens. This is a single arm, open-label, Phase II study of CLOFARABINE in adult patients with refractory or relapsed acute myelogenous leukemia (AML). Qualified patients must be refractory to one or two induction regimens, or have relapsed \< one year from the date of confirmation of the initial complete remission (CR). There will be two phases in this study - an Induction phase and a Consolidation phase.
Interventions
Sponsors
Genzyme, a Sanofi Company
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* note: For inclusion and
Exclusion criteria
, a regimen is defined as including Induction, Consolidation, and Maintenance therapies. * Diagnosis of AML according to FAB classification * Must not be eligible for therapy of higher curative potential, and must be in first or subsequent relapse and/or refractory * A Karnofsky Performance Status (KPS) of greater than or equal to 60. * If female of childbearing potential, patients must have a negative serum or urine pregnancy test within 7 days of study enrollment. Men and women with reproductive potential must use as an effective contraceptive method while enrolled in the study. Patients must have contraceptive and/or fertility counseling prior to entering the study, i.e., information on sperm banking, etc. * Signed, written informed consent. * Ability to comply with study procedures and follow-up examinations. * Adequate organ function as indicated by specific laboratory values (defined in the protocol), obtained within two weeks prior to registration. * Classified as AML FAB M3 (Acute Promyelocytic leukemia) and have been treated with at least 2 regimens (a retinoic acid containing regimen and an arsenic trioxide containing regimen) before being considered for this study.
Countries
United States
Outcome results
None listed