Therapy of Relapsed AML With Chemotherapy and Dendritic Cell Activated Lymphocytes

Not Applicable

Withdrawn

• Conditions: Acute Myelogenous Leukemia; Chronic Myelogenous Leukemia
• Interventions: Biological: Dendritic Cell Activated Lymphocyte

• Registration Number: NCT00038870
• Lead Sponsor: M.D. Anderson Cancer Center

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.

Study Timeline

• Study Start: 2001-01-31
• Study First Submitted: 2002-06-05
• Study First Submitted QC: 2002-06-06
• Study First Posted: 2002-06-07
• Primary Completion: 2003-01-14
• Study Completion: 2003-01-14
• Status Verified: 2018-10
• Last Update Submitted: 2018-10-24
• Last Update Posted: 2018-10-25

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Dendritic Cell Activated Lymphocytes	Dendritic Cell Activated Lymphocyte	-