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 (Responsible Party):
Sanofi ( Genzyme, a Sanofi Company )
ClinicalTrials.gov Identifier:
NCT00924443
First received: June 17, 2009
Last updated: March 30, 2015
Last verified: March 2015
  Purpose

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.


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 Sanofi:

Primary Outcome Measures:
  • Overall Response Rate (ORR) [ Time Frame: At month 20 ] [ Designated as safety issue: No ]

    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.



Secondary Outcome Measures:
  • Rate of Response (Complete, Complete With Incomplete Blood Count Recovery, Partial) [ Time Frame: At month 20 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]
    Duration was calculated by Kaplan-Meier estimates

  • Overall Survival [ Time Frame: From 20 months up to 48 months ] [ Designated as safety issue: No ]
    Calculated by Kaplan-Meier estimates

  • Duration of Complete Remission [ Time Frame: From 20 months up to 48 months ] [ Designated as safety issue: No ]
    Duration was calculated by Kaplan- Meier estimates


Enrollment: 69
Study Start Date: June 2004
Study Completion Date: March 2008
Primary Completion Date: June 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Clofarabine
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.
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
Somerset, 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: Sanofi ( Genzyme, a Sanofi Company )
ClinicalTrials.gov Identifier: NCT00924443     History of Changes
Other Study ID Numbers: BIOV-121
Study First Received: June 17, 2009
Results First Received: March 20, 2015
Last Updated: March 30, 2015
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
Ireland: Irish Medicines Board
Italy: Ministry of Health

Keywords provided by Sanofi:
acute myelogenous leukemia
acute myeloid leukemia
clolar
evoltra
clofarabine
untreated acute leukemia
adult acute leukemia

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

ClinicalTrials.gov processed this record on June 30, 2015