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Sponsored by: |
M.D. Anderson Cancer Center |
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Information provided by: | M.D. Anderson Cancer Center |
ClinicalTrials.gov Identifier: | NCT00038870 |
Condition | Intervention |
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Acute Myelogenous Leukemia Chronic Myelogenous Leukemia |
Procedure: Dendritic Cell Activated Lymphocyte |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Therapy of Relapsed AML With Chemotherapy and Dendritic Cell Activated Lymphocytes |
Estimated Enrollment: | 48 |
Study Start Date: | January 2001 |
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.
Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion:
Exclusion:
History of overt cardiac failure, systemic autoimmune disease or expected need for steroid therapy.
Study ID Numbers: | ID99-075 |
Study First Received: | June 5, 2002 |
Last Updated: | June 23, 2005 |
ClinicalTrials.gov Identifier: | NCT00038870 History of Changes |
Health Authority: | United States: Food and Drug Administration |
AML CML Dendritic Cells |
Leukemia Acute Myelocytic Leukemia Acute Myeloid Leukemia, Adult Hematologic Diseases Myeloproliferative Disorders |
Leukemia, Myelogenous, Chronic, BCR-ABL Positive Chronic Myelogenous Leukemia Leukemia, Myeloid Bone Marrow Diseases Leukemia, Myeloid, Acute |
Leukemia Neoplasms Neoplasms by Histologic Type Hematologic Diseases Myeloproliferative Disorders |
Leukemia, Myelogenous, Chronic, BCR-ABL Positive Leukemia, Myeloid Bone Marrow Diseases Leukemia, Myeloid, Acute |