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Completed

NCT Number: NCT00924443

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

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.

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Key information

Conditions

Acute Myeloid Leukemia Hematologic Diseases Hemic and Lymphatic Diseases Leukemia Leukemia, Myeloid Leukemia, Myeloid, Acute Neoplasms Neoplasms by Histologic Type

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Dublin, Ireland

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Clofarabine

Drug

Other names: tradename US = Clolar, tradename EU = Evoltra

Primary outcomes

  1. Overall Response Rate (ORR)

    Time frame: At month 20

    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 outcomes

  1. Rate of Response (Complete, Complete With Incomplete Blood Count Recovery, Partial)

    Time frame: At month 20

    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.

  2. Duration of Overall Response

    Time frame: From 20 months up to 48 months

    Duration was calculated by Kaplan-Meier estimates

  3. Overall Survival

    Time frame: From 20 months up to 48 months

    Calculated by Kaplan-Meier estimates

  4. Duration of Complete Remission

    Time frame: From 20 months up to 48 months

    Duration was calculated by Kaplan- Meier estimates

Sponsors and collaborators

Lead sponsor

Genzyme, a Sanofi Company

Industry

Collaborators

  • Bioenvision

Registry information

Official study title

A Phase II Trial of Clofarabine in Older Patients With Acute Myeloid Leukemia for Whom Intensive Chemotherapy is Not Considered Suitable

Important dates

Study start
2004
Primary completion
2006
Study completion
2008
First posted
Jun 19, 2009
Registry last updated
Apr 1, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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