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| Descriptive Information Fields | |||||
| 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 | ||||
| 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. |
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| 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. |
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| Study Phase | |||||
| Study Type † | Interventional | ||||
| Study Design † | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study | ||||
| 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 ] | ||||
| Secondary Outcome Measure † | 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 ] |
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| Condition † | Leukemia, Myeloid, Chronic AML MDS Leukemia, Lymphocytic, Acute |
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| Intervention † | Procedure: Donor Lymphocyte Infusion | ||||
| MEDLINE PMIDs | |||||
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| Recruitment Information Fields | |||||
| Recruitment Status † | Active, not recruiting | ||||
| Enrollment † | 100 | ||||
| Start Date † | December 1995 | ||||
| Completion Date | February 2010 | ||||
| Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 1 Year to 60 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts †† | |||||
| Location Countries † | United States | ||||
| Administrative Information Fields | |||||
| NCT ID † | NCT00167167 | ||||
| Organization ID | 9510M10277 | ||||
| Secondary IDs †† | MT1995-24 | ||||
| Study Sponsor † | Miller, Jeffrey S., MD | ||||
| Collaborators †† | |||||
| Investigators † |
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| Information Provided By | University of Minnesota | ||||
| Verification Date | June 2008 | ||||
| First Received Date † | September 9, 2005 | ||||
| Last Updated Date | June 12, 2008 | ||||