A Study of Clofarabine in Older Patients With Acute Myeloid Leukemia (AML) for Whom Chemotherapy Is Not Suitable
A Phase II Trial of Clofarabine in Older Patients With Acute Myeloid Leukemia for Whom Intensive Chemotherapy is Not Considered Suitable
1 other identifier
interventional
69
3 countries
15
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Jun 2004
Typical duration for phase_2
15 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2008
CompletedFirst Submitted
Initial submission to the registry
June 17, 2009
CompletedFirst Posted
Study publicly available on registry
June 19, 2009
CompletedResults Posted
Study results publicly available
April 1, 2015
CompletedApril 1, 2015
March 1, 2015
2 years
June 17, 2009
March 20, 2015
March 30, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
At month 20
Secondary Outcomes (4)
Rate of Response (Complete, Complete With Incomplete Blood Count Recovery, Partial)
At month 20
Duration of Overall Response
From 20 months up to 48 months
Overall Survival
From 20 months up to 48 months
Duration of Complete Remission
From 20 months up to 48 months
Study Arms (1)
Clofarabine
EXPERIMENTALClofarabine 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.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Genzyme, a Sanofi Companylead
- Bioenvisioncollaborator
Study Sites (15)
Unknown Facility
Dublin, Ireland
Unknown Facility
Bologna, Italy
Unknown Facility
Rome, Italy
Unknown Facility
Belfast, Northern Ireland, United Kingdom
Unknown Facility
Aberdeen, United Kingdom
Unknown Facility
Birmingham, United Kingdom
Unknown Facility
Cardiff, United Kingdom
Unknown Facility
Edinburgh, United Kingdom
Unknown Facility
Leicester, United Kingdom
Unknown Facility
Liverpool, United Kingdom
Unknown Facility
London, United Kingdom
Unknown Facility
Manchester, United Kingdom
Unknown Facility
Nottingham, United Kingdom
Unknown Facility
Somerset, United Kingdom
Unknown Facility
Taunton, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Trial Transparency Team
- Organization
- Sanofi
Study Officials
- STUDY DIRECTOR
Medical Monitor
Genzyme, a Sanofi Company
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 17, 2009
First Posted
June 19, 2009
Study Start
June 1, 2004
Primary Completion
June 1, 2006
Study Completion
March 1, 2008
Last Updated
April 1, 2015
Results First Posted
April 1, 2015
Record last verified: 2015-03