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Anti-Leukemic Dendritic Cell Activated Donor Lymphocytes

M.D. Anderson Cancer Center logo

M.D. Anderson Cancer Center

Status and phase

Terminated
Phase 1

Conditions

Leukemia, Myelocytic, Acute

Treatments

Biological: Stem Cell Transplant
Procedure: Apheresis

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT00048100
ID00-034

Details and patient eligibility

About

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.

Enrollment

2 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No 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.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

2 participants in 1 patient group

Apheresis + Transplant
Experimental group
Description:
Skin biopsy \& either a leukodepletion apheresis or an additional marrow aspiration prior to marrow or stem cell transplantation.
Treatment:
Procedure: Apheresis
Biological: Stem Cell Transplant

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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