Donor Lymphocyte Infusion (DLI) for Relapsed (Post Transplant) Leukemia - Full Text View

Sponsored by:	Miller, Jeffrey S., MD
Information provided by:	University of Minnesota
ClinicalTrials.gov Identifier:	NCT00167167

Purpose

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	Intervention
Leukemia, Myeloid, Chronic AML MDS Leukemia, Lymphocytic, Acute	Procedure: Donor Lymphocyte Infusion

MedlinePlus related topics: Bone Marrow Transplantation Cancer Leukemia, Adult Acute Leukemia, Adult Chronic Leukemia, Childhood

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Official Title:	Treatment of Relapsed Leukemia After Allogeneic Bone Marrow Transplantation Using Donor-Derived Lymphocytes

Further study details as provided by University of Minnesota:

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Toxicity [ Time Frame: during the infusion and immediately thereafter ] [ Designated as safety issue: Yes ]
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. ] [ Designated as safety issue: Yes ]
Graft-versus-host disease will be staged using criteria routinely used in allogeneic bone marrow transplant settings and will be tabulated. [ Time Frame: ongoing ] [ Designated as safety issue: No ]
Marrow Aplasia including duration, treatment and outcomes. [ Time Frame: ongoing ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	100
Study Start Date:	December 1995
Estimated Study Completion Date:	February 2010
Estimated Primary Completion Date:	February 2010 (Final data collection date for primary outcome measure)

Intervention Details:

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.

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.

Eligibility

Ages Eligible for Study:	1 Year to 60 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00167167

Locations

United States, Minnesota
University of Minnesota Medical Center
Minneapolis, Minnesota, United States, 55455

Sponsors and Collaborators

Miller, Jeffrey S., MD

Investigators

Principal Investigator:

Jeffrey Miller, MD

University of Minnesota Medical Center

More Information

Responsible Party:	University of Minnesota Medical Center ( Jeffrey Miller, MD )
Study ID Numbers:	9510M10277, MT1995-24
Study First Received:	September 9, 2005
Last Updated:	June 12, 2008
ClinicalTrials.gov Identifier:	NCT00167167
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Minnesota:

Donor Lymphocyte Infusion
relapse
post-transplant

Study placed in the following topic categories:

Lymphatic Diseases
Leukemia
Leukemia, Lymphoid
Immunoproliferative Disorders
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Hematologic Diseases

Myeloproliferative Disorders
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Leukemia, Myeloid
Bone Marrow Diseases
Lymphoproliferative Disorders
Lymphoma

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Histologic Type
Immune System Diseases

ClinicalTrials.gov processed this record on January 15, 2009