Donor Lymphocyte Infusion (DLI) for Relapsed (Post Transplant) Leukemia



Status:Completed
Conditions:Blood Cancer, Blood Cancer, Hematology
Therapuetic Areas:Hematology, Oncology
Healthy:No
Age Range:1 - 60
Updated:12/1/2017
Start Date:December 1995
End Date:January 2006

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Treatment of Relapsed Leukemia After Allogeneic Bone Marrow Transplantation Using Donor-derived Lymphocytes

In this study our hypothesis is that infusion of donor lymphocyte immune cells from the
subject's bone marrow donor will activate the subject's immune system to attack their cancer.

We will collect immune cells or lymphocytes from the donor's blood using a cell separator.
The blood lymphocytes will be given to the subjects through a catheter. If the subjects have
no complications of the first course of infusions, we may decide to give them "lymphocytes"
aa second time while subjects are in remission in an attempt to prevent their disease from
relapsing. A bone marrow test will be taken prior to infusion of lymphocytes as part of the
clinical evaluation to receive this treatment. After lymphocyte infusions, a bone marrow will
be examined about every three months for the first year to monitor progress from this
therapy.

Inclusion Criteria:

- Patients with CML, AML, MDS or ALL relapsed after related or unrelated donor
allogeneic marrow transplantation.

- Patients must be within one year of identification of relapse or if beyond that time
period, must have some evidence of donor DNA by RFLP or cytogenetics.

- Patients may have evidence of relapse based on molecular, cytogenetic or morphologic
criteria.

- CML patients must have cytogenetic evidence of relapse or if Ph negative to start,
obvious evidence of relapse other than minimal residual disease.

- Patients must have <30% marrow blasts on a marrow biopsy performed within two weeks of
the first donor lymphocyte infusion.

- Patients with >30% blasts can become eligible for donor lymphocytes after reinduction
with any standard therapy regimen.

- Patients with AML, MDS or ALL achieving a CR with standard therapy regimens are
eligible for this protocol.

- Patients who relapse with their initial disease or develop a second malignancy after
related or unrelated donor allogeneic marrow transplantation with other initial
diagnoses (such as but not limited to CLL, lymphoma, myeloma, juvenile CML, sarcoma,
breast cancer) may also be included in this protocol. Patients will be eligible with
or without other adjunct chemotherapy or radiation therapy. Post-transplant lymphomas
(often referred to as EBV-associated lymphomas) will be eligible for donor leukocyte
infusions on this protocol. Treatment with donor leukocytes under this protocol is
restricted to malignant diseases only. Graft failure or relapse of non-malignant
disorders is excluded from receiving donor leukocyte infusions on this protocol.
Autologous transplant patients who relapse are not eligible for this protocol.
Patients with malignant diseases amenable to other curative therapy are not eligible
(i.e. skin cancers).

Exclusion Criteria:

- Patients with concurrent signs of acute or chronic graft-versus-host disease requiring
ongoing treatment at the time of relapse will be ineligible.

- Patients with >30% marrow blasts at the time of therapy will be ineligible.

- Patients on prednisone, cyclosporine, Imuran or other immunosuppressive medications
are not eligible until these medications are discontinued for at least 2 weeks without
a flare of GVHD.

- CML patients in complete cytogenetic remission who are bcr/abl positive by PCR only
are not eligible.
We found this trial at
1
site
Minneapolis, Minnesota 55455
?
mi
from
Minneapolis, MN
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