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

This study has been completed.
Sponsor:
Information provided by:
Masonic Cancer Center, University of Minnesota
ClinicalTrials.gov Identifier:
NCT00167167
First received: September 9, 2005
Last updated: July 7, 2009
Last verified: July 2009

September 9, 2005
July 7, 2009
December 1995
January 2006   (final data collection date for primary outcome measure)
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 ]
Freedom of Disease: Bone marrow histology, cytogenetic analysis and RFLP will be studied before, at 3 months, 6 months, 9 months and 12 months after donor lymphocyte infusions. Data will be collected and tabulated.
Complete list of historical versions of study NCT00167167 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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.
Not Provided
Not Provided
 
Donor Lymphocyte Infusion (DLI) for Relapsed (Post Transplant) Leukemia
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.

Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Leukemia, Myeloid, Chronic
  • AML
  • MDS
  • Leukemia, Lymphocytic, Acute
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.
Experimental: BMT patients
All patients treated.
Intervention: Procedure: Donor Lymphocyte Infusion
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
January 2006
January 2006   (final data collection date for primary outcome measure)

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.
Both
1 Year to 60 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00167167
9510M10277, MT1995-24, 1996LS146
No
Jeffrey Miller, MD, Masonic Cancer Center, University of Minnesota
Masonic Cancer Center, University of Minnesota
Not Provided
Principal Investigator: Jeffrey Miller, MD University of Minnesota Medical Center
Masonic Cancer Center, University of Minnesota
July 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP