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Home > "T" Clinical Trials Conditions > Therapy of Relapsed AML with Chemotherapy and Dendritic Cell Activated Lymphocytes  Therapy of Relapsed AML with Chemotherapy and Dendritic Cell Activated Lymphocytes
Therapy of Relapsed AML with Chemotherapy and Dendritic Cell Activated Lymphocytes
For Condition: Acute Myelogenous Leukemia,Chronic Myelogenous Leukemia
Status: Terminated
Sponsor(s): M.D. Anderson Cancer Center ,
Synopsis: 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.
Details: 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:
Study Type: Interventional, Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 18 Years/75 Years
Genders: Both
Protocol Entry 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.
Total Enrollment: 48
Location and Contact Information:
MD Anderson Cancer Center
Houston, Texas, 77030
United States
Additional Information:
Study ID Numbers: ID99-075;
Study Start Date: January 2001
Record last reviewed: January 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00038870
Other Chronic Myelogenous Leukemia Studies:
1. Megadose CD34 Selected Progenitor Cells for Transplantation in Patients with Advanced Hematological Malignant Diseases
2. Molecular Epidemiology of Childhood Leukemia in Northern and Central California
3. Dose-finding, open-label study in patients with Acute Myelogenous Leukemia after they receive a transplantation
4. Dosing Study of Ara-C/EL625/Idarubicin in Refractory and Relapsed AML
5. Therapy of Relapsed AML with Chemotherapy and Dendritic Cell Activated Lymphocytes
Related Studies:
Other Chronic Myelogenous Leukemia Clinical Trials
Other Texas Clinical Trials
Other Houston Clinical Trials
Therapy of Relapsed AML with Chemotherapy and Dendritic Cell Activated Lymphocytes
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