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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT00038870
Other study ID # ID99-075
Secondary ID
Status Withdrawn
Phase N/A
First received
Last updated
Start date January 31, 2001
Est. completion date January 14, 2003

Study information

Verified date October 2018
Source M.D. Anderson Cancer Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date January 14, 2003
Est. primary completion date January 14, 2003
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Biological:
Dendritic Cell Activated Lymphocyte


Locations

Country Name City State
n/a

Sponsors (3)

Lead Sponsor Collaborator
M.D. Anderson Cancer Center Immunex Corporation, National Cancer Institute (NCI)
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