Therapy of Relapsed AML With Chemotherapy and Dendritic Cell Activated Lymphocytes

This study has been withdrawn prior to enrollment.
(Slow accrual.)
Sponsor:
Collaborators:
Immunex Corporation
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00038870
First received: June 5, 2002
Last updated: August 2, 2012
Last verified: August 2012
  Purpose
  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.

Condition Intervention
Acute Myelogenous Leukemia
Chronic Myelogenous Leukemia
Biological: Dendritic Cell Activated Lymphocyte

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Therapy of Relapsed AML With Chemotherapy and Dendritic Cell Activated Lymphocytes

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Enrollment: 0
Study Start Date: January 2001
Study Completion Date: January 2003
Primary Completion Date: January 2003 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Dendritic Cell Activated Lymphocytes Biological: Dendritic Cell Activated Lymphocyte
Other Names:
  • autologous leukemia derived dendritic cell activated lymphocytes
  • DC/AL

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  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: NCT00038870

Locations
United States, Texas
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Immunex Corporation
Investigators
Principal Investigator: Richard Champlin, MD,BS UT MD Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00038870     History of Changes
Other Study ID Numbers: ID99-075
Study First Received: June 5, 2002
Last Updated: August 2, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by M.D. Anderson Cancer Center:
AML
CML
Dendritic Cells

Additional relevant MeSH terms:
Leukemia
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Bone Marrow Diseases
Hematologic Diseases
Myeloproliferative Disorders
Neoplasms
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on October 23, 2014