Anti-Leukemic Dendritic Cell Activated Donor Lymphocytes

Leukemia, Myelocytic, Acute Clinical Trial

Official title:

Anti-Leukemic Dendritic Cell Activated Donor Lymphocytes for Therapy of Relapsed Leukemia After Allogeneic Stem Cell Therapy

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00048100
• Other study ID #: ID00-034
• Status: Terminated
• Phase: Phase 1
• Start date: February 2001
• Est. completion date: May 2005

Study information

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

Clinical Trial Summary

Objectives:

1. Determine the toxicity of infusions of allogeneic donor lymphocytes activated by acute leukemia derived dendritic cells (DC/ADL) in relapsed patients after allo-stem cell transplants.

2. Quantitate the alloreactivity of DC/ADL and circulating immune effector cells in patients after infusion.

3. Assess efficacy of acute myelogenous leukemia (AML) or Chronic Myelogenous Leukemia in Blastic Crisis (CML-BC) derived dendritic cells and activated lymphocytes in promoting and sustaining remission in patients with relapse after allo-BMT or stem cell transplant.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: May 2005
• Est. primary completion date: May 2005
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• AML (any type except M3) or CIVIL in blast crisis with greater than or equal to 20% bone marrow blasts at the time of related donor marrow or stem cell transplantation or at relapse post transplant.

• Willing to undergo a skin biopsy and either a leukodepletion apheresis or an additional marrow aspiration.

• Stem cell or marrow donor willing to have apheresis for T-Cell collection.

• Written voluntary informed consent must be obtained from patient and donor.

Exclusion Criteria:

• Medical, social or psychologic factors which would prevent the patient from receiving or cooperating with the full course of therapy or understanding the informed consent procedure.

• AML French-American-British (FAB) subtype M3.

Related Conditions & MeSH terms

• Leukemia
• Leukemia, Myelocytic, Acute
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute

Intervention

Procedure:
• Apheresis
Apheresis for T-Cell collection

Biological:
• Stem Cell Transplant
Stem cell or marrow infusions of allogeneic donor lymphocytes activated by acute leukemia derived dendritic cells (DC/ADL).

Locations

Country	Name	City	State
United States	M.D. Anderson Cancer Center	Houston	Texas

Sponsors (2)

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

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Participant Toxicity Levels	Participant toxicity of infusions of allogeneic donor lymphocytes activated by acute leukemia derived dendritic cells (DC/ADL) in relapsed patients after allo-stem cell transplants.	From stem cell transplant baseline to 30 plus days post transplant.

External Links

•   UT MD Anderson Cancer Center website