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

1 Year
60 Years
Not Enrolling
Leukemia, Myeloid, Chronic, AML, MDS, Leukemia, Lymphocytic, Acute

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Trial Information

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

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

- 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.

Type of Study:


Study Design:

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

Outcome Measure:

Freedom of Disease: Bone marrow histology, cytogenetic analysis and RFLP will be studied. Data will be collected and tabulated.

Outcome Time Frame:

before, at 3 months, 6 months, 9 months and 12 months after donor lymphocyte infusions

Safety Issue:


Principal Investigator

Jeffrey Miller, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Minnesota Medical Center


United States: Institutional Review Board

Study ID:




Start Date:

December 1995

Completion Date:

January 2006

Related Keywords:

  • Leukemia, Myeloid, Chronic
  • AML
  • MDS
  • Leukemia, Lymphocytic, Acute
  • Donor Lymphocyte Infusion
  • relapse
  • post-transplant
  • Leukemia
  • Leukemia, Lymphoid
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma
  • Leukemia, Myeloid
  • Leukemia, Myelogenous, Chronic, BCR-ABL Positive



University of Minnesota Medical CenterMinneapolis, Minnesota  55455