Anti-Leukemic Dendritic Cell Activated Donor Lymphocytes

NCT ID: NCT00048100

Last Updated: 2018-10-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

2 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-02-28

Study Completion Date

2005-05-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Leukemia, Myelocytic, Acute

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Apheresis + Transplant

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

Group Type EXPERIMENTAL

Apheresis

Intervention Type PROCEDURE

Apheresis for T-Cell collection

Stem Cell Transplant

Intervention Type BIOLOGICAL

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

Interventions

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Apheresis

Apheresis for T-Cell collection

Intervention Type PROCEDURE

Stem Cell Transplant

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

Intervention Type BIOLOGICAL

Other Intervention Names

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SCT Stem Cell Transplantation

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

M.D. Anderson Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Elizabeth J. Shpall, MD

Role: PRINCIPAL_INVESTIGATOR

UT MD Anderson Cancer Center

Locations

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M.D. Anderson Cancer Center

Houston, Texas, United States

Site Status

Countries

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United States

Related Links

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http://www.mdanderson.org

UT MD Anderson Cancer Center website

Other Identifiers

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ID00-034

Identifier Type: -

Identifier Source: org_study_id

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