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LLME Treated Cellular Immunotherapy Following T-cell Depleted Allogeneic Heamtopoietic Stem Cell Transplantation for Acceleration of Immune Reconstitution

Phase 2
16 Years
Not Enrolling

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Trial Information

LLME Treated Cellular Immunotherapy Following T-cell Depleted Allogeneic Heamtopoietic Stem Cell Transplantation for Acceleration of Immune Reconstitution

If you agree to participate in this research study you will be evaluated during the 4th-6th
week after your transplant to determine the number of CD4 cells in your circulation and to
determine that your body has eliminated all of the immune suppressing medicines used around
the time of your transplant. This will be performed by studying the cells from two tubes of
blood. Thereafter, blood cells will be obtained from your donor (the same donor as used for
the transplant). These cells from the donor will be treated with LLME in the laboratory.
The cells will then be washed to eliminate the LLME, counted, and the desired number will be
administered to you by transfusion.

Four to six weeks later, you will have additional blood drawn (2-3 teaspoons) to determine
the number of CD4 cells in your blood. If the number is below 100, you will be given
another transfusion of LLME treated cells, but you will receive a larger number of cells.
Above 100 CD4 cells, the risk of infections appears to decrease. This will be repeated
every 8 weeks provided that you and your donor remain willing to continue until one of three
things happens. The three things that would cause us to stop further DLI would be: (1) you
develop a CD4 count of over 100, (2) you develop evidence of GVHD, or (3) we reach the
maximum practical number of cells which your donor could provide.

Your donor will also be reevaluated by medical history, physical examination, and blood
tests to ensure that he/she remains healthy and can undergo the cell donation procedure
safely. He or she will donate the first doses of white cells by drawing a small amount of
blood. Later donations, if necessary, will be collected in a manner that is very similar to
how platelets are normally collected from volunteer donors by the blood bank. The manner in
which the transfusions are given will be similar to that in which you have received red
blood cell and platelet transfusions in the past.

Inclusion Criteria:

- To be treated on this study, patients must have recently undergone a T-cell depleted
allogeneic bone marrow or peripheral blood stem cell transplant from an HLA-matched
sibling donor, an HLA matched unrelated donor, or an HLA partially matched (single
antigen mismatched, two antigen mismatched, or haplodisparate) donor. Patients will
be counseled and will sign informed consent for this study prior to their transplant.
Our intention is to analyze the effectiveness of LLME treated DLI (Donor Lymphocyte
Infusion) on an intent to treat basis. To proceed with this therapy after HSCT,
patients must meet the other selection criteria below at the time of first DLI.
Additionally, discussion prior to transplant helps present the patient (and donor) a
picture of the proposed therapy in its entirety, rather than in piecemeal fashion. A
patient or donor's unwillingness to participate in this study will in no way affect
their eligibility for transplant therapy at our center.

- At the time of initial DLI therapy, patients must be between 28 and 42 days post
allogeneic HSCT or between 28 and 42 days after the last dose of ATG if that agent
was used after the transplant as part of their graft rejection prophylaxis. They
must also meet the following criteria during the week prior to first infusion:

- Patients must have achieved primary engraftment with an absolute neutrophil count of
at least 1000 per l for 3 consecutive days.

- Patients must have a CD4+ lymphocyte count of less than 200 per l. An absolute
lymphocyte count of less than 200 per l will be taken as prime facie evidence that
the CD4+ lymphocyte count meets this criteria.

- Patients may not exhibit overt hematologic manifestations of relapse or persistent
disease. Evidence of recurrent/persistent disease based primarily on flow cytometry,
cytogenetics, chimerism analysis, or other molecular studies does not by itself
represent grounds for exclusion.

- Patients must be 16 years of age or older. There is no upper age limit for this

- Patients must not be pregnant.

- Patients must not have any documented graft-versus-host disease.

Type of Study:


Study Design:

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Neal Flomenberg, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Thomas Jefferson University, Department of Medical Oncology


United States: Institutional Review Board

Study ID:




Start Date:

September 2000

Completion Date:

August 2009

Related Keywords:




Thomas Jefferson University Hospital Philadelphia, Pennsylvania  19131