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.
Note: This clinical trial was conducted by Bioenvision Ltd. Bioenvision Ltd. was acquired by Genzyme Corporation Oct 2007.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
69
Unnamed facility
Dublin, Ireland
Unnamed facility
Bologna, Italy
Unnamed facility
Rome, Italy
Unnamed facility
Belfast, Northern Ireland, United Kingdom
Overall Response Rate (ORR)
ORR rate was defined as the sum of the number of participants in the study population with complete remission (CR), complete remission with incomplete blood count recovery (CRi), or partial remission (PR) divided by the total number of participants in the study population. ORR rate was determined by assessment of morphology and blast count from bone marrow aspirates and peripheral blood performed prior to first dose and at the end of clofarabine treatment. The ORR was determined at the end of each cycle of clofarabine, and assessed using the participant's best response to clofarabine treatment.
Time frame: At month 20
Rate of Response (Complete, Complete With Incomplete Blood Count Recovery, Partial)
Response was determined by assessment of morphology and blast count from bone marrow aspirates and peripheral blood performed prior to first dose and at the end of clofarabine treatment. Response was determined at the end of each cycle of clofarabine, and assessed using the participant's best response to clofarabine treatment.
Time frame: At month 20
Duration of Overall Response
Duration was calculated by Kaplan-Meier estimates
Time frame: From 20 months up to 48 months
Overall Survival
Calculated by Kaplan-Meier estimates
Time frame: From 20 months up to 48 months
Duration of Complete Remission
Duration was calculated by Kaplan- Meier estimates
Time frame: From 20 months up to 48 months
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Unnamed facility
Aberdeen, United Kingdom
Unnamed facility
Birmingham, United Kingdom
Unnamed facility
Cardiff, United Kingdom
Unnamed facility
Edinburgh, United Kingdom
Unnamed facility
Leicester, United Kingdom
Unnamed facility
Liverpool, United Kingdom
...and 5 more locations