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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00167167
Recruitment Status : Completed
First Posted : September 14, 2005
Last Update Posted : November 29, 2017
Information provided by:
Masonic Cancer Center, University of Minnesota

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Leukemia, Myeloid, Chronic AML MDS Leukemia, Lymphocytic, Acute Procedure: Donor Lymphocyte Infusion Not Applicable

Detailed Description:
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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Treatment of Relapsed Leukemia After Allogeneic Bone Marrow Transplantation Using Donor-derived Lymphocytes
Study Start Date : December 1995
Actual Primary Completion Date : January 2006
Actual Study Completion Date : January 2006

Arm Intervention/treatment
Experimental: BMT patients
All patients treated.
Procedure: Donor Lymphocyte Infusion
Certain immune cells in your donor's blood called "lymphocytes" have been shown to fight cancer after bone marrow transplantation. We plan to transfuse large numbers of donor's "lymphocytes" in the hope of activating the recipient's immune system to attack cancer.

Primary Outcome Measures :
  1. Freedom of Disease: Bone marrow histology, cytogenetic analysis and RFLP will be studied. Data will be collected and tabulated. [ Time Frame: before, at 3 months, 6 months, 9 months and 12 months after donor lymphocyte infusions ]

Secondary Outcome Measures :
  1. Toxicity [ Time Frame: during the infusion and immediately thereafter ]
  2. All data concerning acute toxicity including allergic reactions, capillary leak syndrome, and other Grade 4 toxicity will be collected and tabulated. [ Time Frame: during the infusion,immediately thereafter, and at 1 month, 3 months, 6 months, 9 months, 1 year and yearly. ]
  3. Graft-versus-host disease will be staged using criteria routinely used in allogeneic bone marrow transplant settings and will be tabulated. [ Time Frame: ongoing ]
  4. Marrow Aplasia including duration, treatment and outcomes. [ Time Frame: ongoing ]

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Ages Eligible for Study:   1 Year to 60 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00167167

United States, Minnesota
University of Minnesota Medical Center
Minneapolis, Minnesota, United States, 55455
Sponsors and Collaborators
Masonic Cancer Center, University of Minnesota
Principal Investigator: Jeffrey Miller, MD University of Minnesota Medical Center

Responsible Party: Jeffrey Miller, MD, Masonic Cancer Center, University of Minnesota Identifier: NCT00167167     History of Changes
Other Study ID Numbers: 9510M10277
First Posted: September 14, 2005    Key Record Dates
Last Update Posted: November 29, 2017
Last Verified: November 2017

Keywords provided by Masonic Cancer Center, University of Minnesota:
Donor Lymphocyte Infusion

Additional relevant MeSH terms:
Leukemia, Myeloid
Leukemia, Lymphoid
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Myeloproliferative Disorders
Bone Marrow Diseases
Hematologic Diseases