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Therapy of Relapsed AML With Chemotherapy and Dendritic Cell Activated Lymphocytes

Primary Purpose

Acute Myelogenous Leukemia, Chronic Myelogenous Leukemia

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Dendritic Cell Activated Lymphocyte
Sponsored by
M.D. Anderson Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Myelogenous Leukemia focused on measuring AML, CML, Dendritic Cells

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion: AML patients either after first relapse or at diagnosis a) with high-risk cytogenetics such as -7, -5, +8, chromosome 9 or 11 abnormality, or b) WBC > 50,000, or c) age > 60 years*. AML patients are eligible for cell collection if they have > 1000 circulating blasts/mm at diagnosis. CML patients in myeloid blast crisis with > 1000 circulating blasts/mm. Creatinine <2, Bilirubin <3. Age >18. Exclusion: Factors which would prevent the patient from receiving or cooperating with the full course of therapy or understanding the informed consent procedure. Concurrent or expected need for therapy with corticosteroids. Positive antibody to human immunodeficiency virus I. Acute promyelocytic Leukemia (FAB-M3). History of overt cardiac failure, systemic autoimmune disease or expected need for steroid therapy. Patients >60 will be eligible for study but if found to have good prognosis cytogenetics (inversion (16) or t(8;21)) will subsequently be withdrawn from study and treated off protocol without infusion of autologous leukemia derived cells.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Dendritic Cell Activated Lymphocytes

    Arm Description

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    June 5, 2002
    Last Updated
    October 24, 2018
    Sponsor
    M.D. Anderson Cancer Center
    Collaborators
    Immunex Corporation, National Cancer Institute (NCI)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00038870
    Brief Title
    Therapy of Relapsed AML With Chemotherapy and Dendritic Cell Activated Lymphocytes
    Official Title
    Therapy of Relapsed AML With Chemotherapy and Dendritic Cell Activated Lymphocytes
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2018
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Slow accrual.
    Study Start Date
    January 31, 2001 (Actual)
    Primary Completion Date
    January 14, 2003 (Actual)
    Study Completion Date
    January 14, 2003 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    M.D. Anderson Cancer Center
    Collaborators
    Immunex Corporation, National Cancer Institute (NCI)

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Determine the feasibility of generation of autologous Acute Myelogenous Leukemia (AML) or Chronic Myelogenous Leukemia in myeloid blast crisis (CML/BC) derived dendritic cell activated lymphocytes (DC/AL) in poor prognosis patients. Determine the toxicity of autologous leukemia derived dendritic cell activated lymphocytes (DC/AL) in patients with AML or CML/BC. Quantitate circulating immune effector cells in patients after infusion of DC/AL. Record the efficacy of AML or CML/BC derived dendritic cells and activated lymphocytes in promoting and sustaining remission in patients with AML or CML/BC.
    Detailed Description
    Most patients relapsing with AML either fail to achieve second remission or have only brief remissions. Patients more than 60 years of age or having histories of antecedent hematological disorders, prior chemotherapy, or poor risk cytogenetics have generally only short remissions and as a group have two year survivals of less than 10%. Equally patients with myeloid blast crisis of CML often fail to achieve remission or have responses of only brief duration. Laboratory studies have shown that AML leukemic blasts may be induced in culture to differentiate into dendritic cells which in turn may be used activate autologous lymphocytes to acquire leukemia specific cytotoxicity. This trial will assess the feasibility of generation of dendritic cell activated lymphocytes, and toxicity and efficacy of these activated cells given after reinduction chemotherapy. Before this study begins some toxicity information will have been generated in a trial of similar cells given to CML patients.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Acute Myelogenous Leukemia, Chronic Myelogenous Leukemia
    Keywords
    AML, CML, Dendritic Cells

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Dendritic Cell Activated Lymphocytes
    Arm Type
    Experimental
    Intervention Type
    Biological
    Intervention Name(s)
    Dendritic Cell Activated Lymphocyte
    Other Intervention Name(s)
    autologous leukemia derived dendritic cell activated lymphocytes, DC/AL

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion: AML patients either after first relapse or at diagnosis a) with high-risk cytogenetics such as -7, -5, +8, chromosome 9 or 11 abnormality, or b) WBC > 50,000, or c) age > 60 years*. AML patients are eligible for cell collection if they have > 1000 circulating blasts/mm at diagnosis. CML patients in myeloid blast crisis with > 1000 circulating blasts/mm. Creatinine <2, Bilirubin <3. Age >18. Exclusion: Factors which would prevent the patient from receiving or cooperating with the full course of therapy or understanding the informed consent procedure. Concurrent or expected need for therapy with corticosteroids. Positive antibody to human immunodeficiency virus I. Acute promyelocytic Leukemia (FAB-M3). History of overt cardiac failure, systemic autoimmune disease or expected need for steroid therapy. Patients >60 will be eligible for study but if found to have good prognosis cytogenetics (inversion (16) or t(8;21)) will subsequently be withdrawn from study and treated off protocol without infusion of autologous leukemia derived cells.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Richard Champlin, MD,BS
    Organizational Affiliation
    UT MD Anderson Cancer Center
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Links:
    URL
    http://www.mdanderson.org
    Description
    UT MD Anderson Cancer Center website

    Learn more about this trial

    Therapy of Relapsed AML With Chemotherapy and Dendritic Cell Activated Lymphocytes

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