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

Primary Purpose

Leukemia, Myeloid, Chronic, AML, MDS

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Donor Lymphocyte Infusion
Sponsored by
Masonic Cancer Center, University of Minnesota
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Leukemia, Myeloid, Chronic focused on measuring Donor Lymphocyte Infusion, relapse, post-transplant

Eligibility Criteria

1 Year - 60 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Minnesota Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

BMT patients

Arm Description

All patients treated.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Toxicity
All data concerning acute toxicity including allergic reactions, capillary leak syndrome, and other Grade 4 toxicity will be collected and tabulated.
Graft-versus-host disease will be staged using criteria routinely used in allogeneic bone marrow transplant settings and will be tabulated.
Marrow Aplasia including duration, treatment and outcomes.

Full Information

First Posted
September 9, 2005
Last Updated
November 27, 2017
Sponsor
Masonic Cancer Center, University of Minnesota
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1. Study Identification

Unique Protocol Identification Number
NCT00167167
Brief Title
Donor Lymphocyte Infusion (DLI) for Relapsed (Post Transplant) Leukemia
Official Title
Treatment of Relapsed Leukemia After Allogeneic Bone Marrow Transplantation Using Donor-derived Lymphocytes
Study Type
Interventional

2. Study Status

Record Verification Date
November 2017
Overall Recruitment Status
Completed
Study Start Date
December 1995 (undefined)
Primary Completion Date
January 2006 (Actual)
Study Completion Date
January 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Masonic Cancer Center, University of Minnesota

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Leukemia, Myeloid, Chronic, AML, MDS, Leukemia, Lymphocytic, Acute
Keywords
Donor Lymphocyte Infusion, relapse, post-transplant

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
BMT patients
Arm Type
Experimental
Arm Description
All patients treated.
Intervention Type
Procedure
Intervention Name(s)
Donor Lymphocyte Infusion
Intervention Description
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 Measure Information:
Title
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 Measure Information:
Title
Toxicity
Time Frame
during the infusion and immediately thereafter
Title
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.
Title
Graft-versus-host disease will be staged using criteria routinely used in allogeneic bone marrow transplant settings and will be tabulated.
Time Frame
ongoing
Title
Marrow Aplasia including duration, treatment and outcomes.
Time Frame
ongoing

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeffrey Miller, MD
Organizational Affiliation
University of Minnesota Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Minnesota Medical Center
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States

12. IPD Sharing Statement

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

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