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This study has been withdrawn prior to enrollment.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

June 5, 2002
August 2, 2012
January 2001
January 2003   (final data collection date for primary outcome measure)
Not Provided
Not Provided
Complete list of historical versions of study NCT00038870 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Therapy of Relapsed AML With Chemotherapy and Dendritic Cell Activated Lymphocytes
Therapy of Relapsed AML With Chemotherapy and Dendritic Cell Activated Lymphocytes
  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.

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.

Interventional
Not Provided
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Acute Myelogenous Leukemia
  • Chronic Myelogenous Leukemia
Biological: Dendritic Cell Activated Lymphocyte
Other Names:
  • autologous leukemia derived dendritic cell activated lymphocytes
  • DC/AL
Experimental: Dendritic Cell Activated Lymphocytes
Intervention: Biological: Dendritic Cell Activated Lymphocyte
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
January 2003
January 2003   (final data collection date for primary outcome measure)

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.
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00038870
ID99-075
No
M.D. Anderson Cancer Center
M.D. Anderson Cancer Center
  • Immunex Corporation
  • National Cancer Institute (NCI)
Principal Investigator: Richard Champlin, MD,BS UT MD Anderson Cancer Center
M.D. Anderson Cancer Center
August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP