Clinical trial NCT00924443: A Study of Clofarabine in Older Patients With Acute Myeloid Leukemia (AML) for Whom Chemotherapy Is Not Suitable
Official title: A Phase II Trial of Clofarabine in Older Patients With Acute Myeloid Leukemia for Whom Intensive Chemotherapy is Not Considered Suitable
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Acute Myeloid Leukemia
Keywords: acute myelogenous leukemia
acute myeloid leukemia
clolar
evoltra
clofarabine
untreated acute leukemia
adult acute leukemia
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
Collaborators: name: Bioenvision
First posted: 2009-06-19
Enrollment: 69
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Detailed description: Note: This clinical trial was conducted by Bioenvision Ltd. Bioenvision Ltd. was acquired by Genzyme Corporation Oct 2007.

Eligibility 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

Primary outcomes:
measure: Overall Response Rate (ORR)
timeFrame: At month 20
Secondary outcomes:
measure: Rate of Response (Complete, Complete With Incomplete Blood Count Recovery, Partial)
timeFrame: At month 20
measure: Duration of Overall Response
timeFrame: From 20 months up to 48 months
measure: Overall Survival
timeFrame: From 20 months up to 48 months
measure: Duration of Complete Remission
timeFrame: From 20 months up to 48 months
Other outcomes:
Locations:
city: Dublin
country: Ireland
city: Bologna
country: Italy
city: Rome
country: Italy
city: Belfast
country: United Kingdom
state: Northern Ireland
city: Aberdeen
country: United Kingdom
city: Birmingham
country: United Kingdom
city: Cardiff
country: United Kingdom
city: Edinburgh
country: United Kingdom
city: Leicester
country: United Kingdom
city: Liverpool
country: United Kingdom
city: London
country: United Kingdom
city: Manchester
country: United Kingdom
city: Nottingham
country: United Kingdom
city: Somerset
country: United Kingdom
city: Taunton
country: United Kingdom
Study officials:
affiliation: Genzyme, a Sanofi Company
name: Medical Monitor
role: STUDY_DIRECTOR
References: