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Therapy of Relapsed AML With Chemotherapy and Dendritic Cell Activated Lymphocytes

18 Years
75 Years
Not Enrolling
Acute Myelogenous Leukemia, Chronic Myelogenous Leukemia

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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

Inclusion Criteria


- 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.


- 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cytogenetics (inversion (16) or t(8;21)) will subsequently be withdrawn from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

Type of Study:


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


United States: Food and Drug Administration

Study ID:




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



UT MD Anderson Cancer Center Houston, Texas  77030