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Investigation of Clofarabine in Acute Leukemias

Primary Purpose

Acute Myelogenous Leukemia, Acute Lymphocytic Leukemia, Chronic Myelogenous Leukemia

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
clofarabine
Sponsored by
University of Texas
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Myelogenous Leukemia focused on measuring clinical, pharmacodynamics, investigational drug clofarabine, AML, ALL, CML-accelerated phase, CML-blastic phase, Chronic Myelogenous Leukemia - accelerated phase, Chronic Myelogenous Leukemia - blastic phase

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Patient is diagnosed with AML, ALL, myelodysplastic syndrome (MDS), and CML in transformation (includes CML-blastic phase and CML-accelerated phase). No prior chemo-, immuno-, or radio-therapy for 2 weeks before entering the study, unless progressive life-threatening leukemia as judged by the treated physician. Adequate liver function (bilirubin </= 2 mg%) and renal function (creatinine </= 2 mg%). Pregnant and lactating females not eligible. Zubrod performance status 0-2 Adequate cardiac status No life-threatening conditions (e.g. infections) which may cause death within 3 weeks.

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    December 2, 2004
    Last Updated
    March 24, 2015
    Sponsor
    University of Texas
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00098033
    Brief Title
    Investigation of Clofarabine in Acute Leukemias
    Official Title
    Phase II Clinical and Pharmacodynamic Investigation of Clofarabine in Acute Leukemias
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2004
    Overall Recruitment Status
    Completed
    Study Start Date
    September 2002 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    September 2005 (undefined)

    3. Sponsor/Collaborators

    Name of the Sponsor
    University of Texas

    4. Oversight

    5. Study Description

    Brief Summary
    The goals and objectives of this project are to evaluate the antileukemic activity of the investigational agent clofarabine in patients with acute myelogenous leukemia (AML), acute lymphocytic leukemia (ALL), and chronic myelogenous leukemia (CML) in accelerated and blastic phases.
    Detailed Description
    The specific aims of the project are (1) conduct the phase II study of clofarabine and evaluate the antileukemic efficacy in AML, ALL, and CML-accelerated and blastic phases in terms of complete response (CR) rate, response duration, and survival; and (2) analyze the relationship between cellular uptake and retention of clofarabine triphosphate (the active metabolite), inhibition of DNA synthesis, and clinical outcome. Completion date provided represents the completion date of the grant per OOPD records

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Acute Myelogenous Leukemia, Acute Lymphocytic Leukemia, Chronic Myelogenous Leukemia
    Keywords
    clinical, pharmacodynamics, investigational drug clofarabine, AML, ALL, CML-accelerated phase, CML-blastic phase, Chronic Myelogenous Leukemia - accelerated phase, Chronic Myelogenous Leukemia - blastic phase

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    64 (false)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    clofarabine

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    12 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Patient is diagnosed with AML, ALL, myelodysplastic syndrome (MDS), and CML in transformation (includes CML-blastic phase and CML-accelerated phase). No prior chemo-, immuno-, or radio-therapy for 2 weeks before entering the study, unless progressive life-threatening leukemia as judged by the treated physician. Adequate liver function (bilirubin </= 2 mg%) and renal function (creatinine </= 2 mg%). Pregnant and lactating females not eligible. Zubrod performance status 0-2 Adequate cardiac status No life-threatening conditions (e.g. infections) which may cause death within 3 weeks.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Hagop M Kantarjian, MD
    Organizational Affiliation
    M.D. Anderson Cancer Center
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Jorge E Cortes, MD
    Organizational Affiliation
    M.D. Anderson Cancer Center
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Citations:
    Citation
    Cortes JE, Gandhi V, et al. Clofarabine (2-chloro-9-(deoxy-2-fluoro-b-D-arabinosfuranosyl)adenine) is active for patients with refractory or relapsed acute leukemia. #739 ASH 2002.
    Results Reference
    background
    Links:
    URL
    http://www.clinicaltrials.gov
    Description
    FDA's clinical trials website

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    Investigation of Clofarabine in Acute Leukemias

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