Therapy of Relapsed AML With Chemotherapy and Dendritic Cell Activated Lymphocytes
18 Years
75 Years
Both
Acute Myelogenous Leukemia, Chronic Myelogenous Leukemia
Trial Information
Therapy of Relapsed AML With Chemotherapy and Dendritic Cell Activated Lymphocytes
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.
Inclusion 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cytogenetics (inversion (16) or t(8;21)) will subsequently be withdrawn from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.
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Principal Investigator
Richard Champlin, MD,BS
Investigator Role:
Principal Investigator
Investigator Affiliation:
UT MD Anderson Cancer Center
Authority:
United States: Food and Drug Administration
Study ID:
ID99-075
NCT ID:
NCT00038870
Start Date:
January 2001
Completion Date:
January 2003
Related Keywords:
- Acute Myelogenous Leukemia
- Chronic Myelogenous Leukemia
- AML
- CML
- Dendritic Cells
- Leukemia
- Leukemia, Myeloid, Acute
- Leukemia, Myeloid
- Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Name | Location |
|---|---|
| UT MD Anderson Cancer Center | Houston, Texas 77030 |
