A Study of Clofarabine in Older Patients With Acute Myeloid Leukemia (AML) for Whom Chemotherapy Is Not Suitable

This study has been completed.
Sponsor:
Collaborator:
Bioenvision
Information provided by:
Genzyme, a Sanofi Company
ClinicalTrials.gov Identifier:
NCT00924443
First received: June 17, 2009
Last updated: June 18, 2009
Last verified: May 2009
  Purpose

The purpose of the study is to determine if treatment of older patients indicated with untreated AML who are not considered to be suitable for intensive chemotherapy, can effectively be treated with Clofarabine.


Condition Intervention Phase
Acute Myeloid Leukemia
Drug: clofarabine
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Trial of Clofarabine in Older Patients With Acute Myeloid Leukemia for Whom Intensive Chemotherapy is Not Considered Suitable

Resource links provided by NLM:


Further study details as provided by Genzyme, a Sanofi Company:

Primary Outcome Measures:
  • Overall response rate [ Time Frame: minimum of 24 months and maximum up to end of study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Rate of response (complete, complete with incomplete blood count recovery, partial) [ Time Frame: minimum of 24 months and maximum up to end of study ] [ Designated as safety issue: No ]
  • Duration of response and remission [ Time Frame: minimum of 24 months and maximum up to end of study ] [ Designated as safety issue: No ]
  • Safety and tolerability [ Time Frame: minimum of 24 months and maximum up to end of study ] [ Designated as safety issue: Yes ]
  • Overall survival [ Time Frame: minimum of 24 months and maximum up to end of study ] [ Designated as safety issue: No ]

Enrollment: 69
Study Start Date: June 2004
Study Completion Date: March 2008
Intervention Details:
    Drug: clofarabine
    Other Names:
    • tradename US = Clolar
    • tradename EU = Evoltra
Detailed Description:

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

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00924443

Locations
Ireland
Dublin, Ireland
Italy
Bologna, Italy
Rome, Italy
United Kingdom
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
Taunton, United Kingdom
Sponsors and Collaborators
Genzyme, a Sanofi Company
Bioenvision
Investigators
Study Director: Medical Monitor Genzyme, a Sanofi Company
  More Information

No publications provided

Responsible Party: Medical Monitor, Genzyme Corporation
ClinicalTrials.gov Identifier: NCT00924443     History of Changes
Other Study ID Numbers: BIOV-121
Study First Received: June 17, 2009
Last Updated: June 18, 2009
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
Ireland: Irish Medicines Board
Italy: Ministry of Health

Keywords provided by Genzyme, a Sanofi Company:
acute myelogenous leukemia
acute myeloid leukemia
clolar
evoltra
clofarabine
untreated acute leukemia
adult acute leukemia

Additional relevant MeSH terms:
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Leukemia
Neoplasms by Histologic Type
Neoplasms
Clofarabine
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 18, 2014