A Study of Clofarabine in Older Patients With Acute Myeloid Leukemia (AML) for Whom Chemotherapy Is Not Suitable
Information source: Sanofi
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Acute Myeloid Leukemia
Intervention: clofarabine (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: Genzyme, a Sanofi Company Official(s) and/or principal investigator(s): Medical Monitor, Study Director, Affiliation: Genzyme, a Sanofi Company
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.
Clinical Details
Official title: A Phase II Trial of Clofarabine in Older Patients With Acute Myeloid Leukemia for Whom Intensive Chemotherapy is Not Considered Suitable
Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Overall Response Rate (ORR)
Secondary outcome: Rate of Response (Complete, Complete With Incomplete Blood Count Recovery, Partial)Duration of Overall Response Overall Survival Duration of Complete Remission
Detailed description:
Note: This clinical trial was conducted by Bioenvision Ltd. Bioenvision Ltd. was acquired by
Genzyme Corporation Oct 2007.
Eligibility
Minimum age: 65 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Locations and Contacts
Dublin, Ireland
Bologna, Italy
Rome, Italy
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
Belfast, Northern Ireland, United Kingdom
Additional Information
Starting date: June 2004
Last updated: March 30, 2015
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