A Study of Clofarabine in Older Patients With Acute Myeloid Leukemia (AML) for Whom Chemotherapy Is Not Suitable
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|ClinicalTrials.gov Identifier: NCT00924443|
Recruitment Status : Completed
First Posted : June 19, 2009
Results First Posted : April 1, 2015
Last Update Posted : April 1, 2015
|Condition or disease||Intervention/treatment||Phase|
|Acute Myeloid Leukemia||Drug: clofarabine||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||69 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Trial of Clofarabine in Older Patients With Acute Myeloid Leukemia for Whom Intensive Chemotherapy is Not Considered Suitable|
|Study Start Date :||June 2004|
|Actual Primary Completion Date :||June 2006|
|Actual Study Completion Date :||March 2008|
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.
- Overall Response Rate (ORR) [ Time Frame: At month 20 ]
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.
- Rate of Response (Complete, Complete With Incomplete Blood Count Recovery, Partial) [ Time Frame: At month 20 ]
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.
- Duration of Overall Response [ Time Frame: From 20 months up to 48 months ]Duration was calculated by Kaplan-Meier estimates
- Overall Survival [ Time Frame: From 20 months up to 48 months ]Calculated by Kaplan-Meier estimates
- Duration of Complete Remission [ Time Frame: From 20 months up to 48 months ]Duration was calculated by Kaplan- Meier estimates
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00924443
|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|
|Study Director:||Medical Monitor||Genzyme, a Sanofi Company|