Therapy of Relapsed AML With Chemotherapy and Dendritic Cell Activated Lymphocytes

NCT00038870 | Withdrawn

• 1 other identifier: ID99-075
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

1. 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. 2.Determine the toxicity of autologous leukemia derived dendritic cell activated lymphocytes (DC/AL) in patients with AML or CML/BC.
3. 3.Quantitate circulating immune effector cells in patients after infusion of DC/AL.
4. 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.

Conditions

Acute Myelogenous Leukemia; Chronic Myelogenous Leukemia

Keywords

AML; CML; Dendritic Cells

Study Arms (1)

Dendritic Cell Activated Lymphocytes

EXPERIMENTAL

Biological: Dendritic Cell Activated Lymphocyte

Interventions

Dendritic Cell Activated Lymphocyte BIOLOGICAL

Also known as: autologous leukemia derived dendritic cell activated lymphocytes, DC/AL

Dendritic Cell Activated Lymphocytes

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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be eligible for study but if found to have good prognosis cytogenetics (inversion (16) or t(8;21)) will subsequently be withdrawn from study and treated off protocol without infusion of autologous leukemia derived cells.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• Immunex Corporation: collaborator
• National Cancer Institute (NCI): collaborator

Related Links

• UT MD Anderson Cancer Center website

MeSH Terms

Conditions

Leukemia, Myeloid, Acute; Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Myeloproliferative Disorders; Bone Marrow Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Richard Champlin, MD,BS

  UT MD Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 5, 2002
• First Posted: June 7, 2002
• Study Start: January 31, 2001
• Primary Completion: January 14, 2003
• Study Completion: January 14, 2003
• Last Updated: October 25, 2018

Record last verified: 2018-10