Therapy of Relapsed AML With Chemotherapy and Dendritic Cell Activated Lymphocytes

Sponsor

M.D. Anderson Cancer Center (Other)

Overall Status

Withdrawn

CT.gov ID

NCT00038870

Collaborator

Immunex Corporation (Industry), National Cancer Institute (NCI) (NIH)

Enrollment

Arm

23.4

Actual Duration (Months)

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Acute Myelogenous Leukemia Chronic Myelogenous Leukemia	Biological: Dendritic Cell Activated Lymphocyte	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Therapy of Relapsed AML With Chemotherapy and Dendritic Cell Activated Lymphocytes

Actual Study Start Date :

Jan 31, 2001

Actual Primary Completion Date :

Jan 14, 2003

Actual Study Completion Date :

Jan 14, 2003

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: Dendritic Cell Activated Lymphocytes

Biological: Dendritic Cell Activated Lymphocyte

Other Names:

autologous leukemia derived dendritic cell activated lymphocytes

DC/AL

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts 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.