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

Sponsor:	M.D. Anderson Cancer Center
Collaborators:	Immunex Corporation National Cancer Institute (NCI)
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:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Therapy of Relapsed AML With Chemotherapy and Dendritic Cell Activated Lymphocytes

Resource links provided by NLM:

MedlinePlus related topics: Acute Myeloid Leukemia Cancer Chronic Myeloid Leukemia Leukemia

U.S. FDA Resources

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

Enrollment:	0
Study Start Date:	January 2001
Study Completion Date:	January 2003
Primary Completion Date:	January 2003 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Dendritic Cell Activated Lymphocytes	Procedure: Dendritic Cell Activated Lymphocyte Other Names: autologous leukemia derived dendritic cell activated lymphocytes DC/AL

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

Sponsors and Collaborators

M.D. Anderson Cancer Center

Immunex Corporation

National Cancer Institute (NCI)

Investigators

Principal Investigator:

Richard Champlin, MD,BS

UT MD Anderson Cancer Center

More Information

Additional Information:

UT MD Anderson Cancer Center website This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Richard Champlin, MD,BS / Professor, UT MD Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT00038870 History of Changes
Other Study ID Numbers:	ID99-075
Study First Received:	June 5, 2002
Last Updated:	October 20, 2010
Health Authority:	United States: Food and Drug Administration

Keywords provided by M.D. Anderson Cancer Center:

AML
CML
Dendritic Cells

Additional relevant MeSH terms:

Leukemia
Leukemia, Myeloid, Acute
Leukemia, Myeloid
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Neoplasms by Histologic Type

Neoplasms
Myeloproliferative Disorders
Bone Marrow Diseases
Hematologic Diseases

ClinicalTrials.gov processed this record on February 12, 2012