Clinical trial NCT00038870: Therapy of Relapsed AML With Chemotherapy and Dendritic Cell Activated Lymphocytes
Official title: Therapy of Relapsed AML With Chemotherapy and Dendritic Cell Activated Lymphocytes
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Acute Myelogenous Leukemia
Chronic Myelogenous Leukemia
Keywords: AML
CML
Dendritic Cells
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
Collaborators: name: Immunex Corporation
name: National Cancer Institute (NCI)
First posted: 2002-06-07
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

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 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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: UT MD Anderson Cancer Center
name: Richard Champlin, MD,BS
role: PRINCIPAL_INVESTIGATOR
References: