Therapy of Relapsed AML With Chemotherapy and Dendritic Cell Activated Lymphocytes - Full Text View

Sponsored by:	M.D. Anderson Cancer Center
Information provided by:	M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT00038870

Purpose

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	Intervention
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

Resource links provided by NLM:

MedlinePlus related topics: Leukemia, Adult Acute Leukemia, Adult Chronic

U.S. FDA Resources

Further study details as provided by M.D. Anderson Cancer Center:

Estimated Enrollment:	48
Study Start Date:	January 2001

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.

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00038870

Locations

United States, Texas
MD Anderson Cancer Center
Houston, Texas, United States, 77030

Sponsors and Collaborators

M.D. Anderson Cancer Center

More Information

No publications provided

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

Keywords provided by M.D. Anderson Cancer Center:

AML
CML
Dendritic Cells

Study placed in the following topic categories:

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

Additional relevant MeSH terms:

Leukemia
Neoplasms
Neoplasms by Histologic Type
Hematologic Diseases
Myeloproliferative Disorders

Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Leukemia, Myeloid
Bone Marrow Diseases
Leukemia, Myeloid, Acute

ClinicalTrials.gov processed this record on September 11, 2009