Anti-Leukemic Dendritic Cell Activated Donor Lymphocytes

Sponsor

M.D. Anderson Cancer Center (Other)

Overall Status

Terminated

CT.gov ID

NCT00048100

Collaborator

National Cancer Institute (NCI) (NIH)

Enrollment

Location

Arm

50.9

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Objectives:

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

Condition or Disease	Intervention/Treatment	Phase
Leukemia, Myelocytic, Acute	Procedure: Apheresis Biological: Stem Cell Transplant	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

2 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Feb 1, 2001

Actual Primary Completion Date :

May 1, 2005

Actual Study Completion Date :

May 1, 2005

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Apheresis + Transplant Skin biopsy & either a leukodepletion apheresis or an additional marrow aspiration prior to marrow or stem cell transplantation.	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). Other Names: SCT Stem Cell Transplantation

Arm

Intervention/Treatment

Experimental: Apheresis + Transplant

Skin biopsy & either a leukodepletion apheresis or an additional marrow aspiration prior to marrow or stem cell transplantation.

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).

Other Names:

SCT

Stem Cell Transplantation

Outcome Measures

Primary Outcome Measures

Participant Toxicity Levels [From stem cell transplant baseline to 30 plus days post transplant.]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.