Therapy of Relapsed AML With Chemotherapy and Dendritic Cell Activated Lymphocytes

October 24, 2018 updated by: M.D. Anderson Cancer Center
  1. 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.
  2. Determine the toxicity of autologous leukemia derived dendritic cell activated lymphocytes (DC/AL) in patients with AML or CML/BC.
  3. Quantitate circulating immune effector cells in patients after infusion of DC/AL.
  4. 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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Dendritic Cell Activated Lymphocytes
Biological: Dendritic Cell Activated Lymphocyte
Other Names:
  • autologous leukemia derived dendritic cell activated lymphocytes
  • DC/AL

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

M.D. Anderson Cancer Center

Collaborators

National Cancer Institute (NCI)
Immunex Corporation

Investigators

  • Principal Investigator: Richard Champlin, MD,BS, UT MD Anderson Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 31, 2001

Primary Completion (Actual)

January 14, 2003

Study Completion (Actual)

January 14, 2003

Study Registration Dates

First Submitted

June 5, 2002

First Submitted That Met QC Criteria

June 6, 2002

First Posted (Estimate)

June 7, 2002

Study Record Updates

Last Update Posted (Actual)

October 25, 2018

Last Update Submitted That Met QC Criteria

October 24, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ID99-075

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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