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NCT00859586 · ClinicalTrials.gov registry record · NA
Mismatched Donor Lymphocyte Infusions for Relapsed Disease Following Allogeneic Stem Cell Transplantation
A NA study of Leukemia, Myeloid, Acute and Leukemia, Lymphoblastic, Acute, sponsored by National Heart, Lung, and Blood Institute (NHLBI).
- Completed
- Registry status
- NA
- Development phase
- 8
- Enrollment target
- 1
- Study location
NCT00859586 is a NA study of Leukemia, Myeloid, Acute and Leukemia, Lymphoblastic, Acute that has completed, run by National Heart, Lung, and Blood Institute (NHLBI). The registered enrollment target is 8 participants, below the 116-participant average among 30 other Leukemia, Myeloid, Acute trials with a reported enrollment target (93% lower). The trial reports 1 study location across 1 state.
The verdict
NCT00859586, a NA study of Leukemia, Myeloid, Acute and Leukemia, Lymphoblastic, Acute, has completed, sponsored by National Heart, Lung, and Blood Institute (NHLBI).
- COMPLETED
- Registry status
- NA
- Development phase
- 8 participants
- Enrollment target
- 1
- Study location
Study Summary
Patients receiving allogeneic stem cell transplantation for hematological malignancies who suffer a relapse of their disease post-transplant have limited treatment options and a poor prognosis. With the exception of patients with chronic leukemias who may achieve prolonged remissions after donor lymphocyte infusions (DLIs), treatments using either chemotherapy or a DLI achieve less than a 10% median survival beyond 6 months. Most of these patients die of progressive leukemia, underlying the need for new therapeutic approaches. Human leukocyte antigen (HLA)-mismatched DLIs appear to possess a more potent graft-versus-leukemia (GvL) effect. However, when given after an HLA-mismatched transplant DLIs have a high risk of causing graft-versus-host disease (GvHD), which can be severe. To reduce the risk of GvHD, infusions of mismatched lymphocytes from an alternative donor may be used to avoid permanent engraftment and associated risk of GvHD. In this study, we propose to use a novel strategy to treat leukemias relapsing after HLA matched allogeneic stem cell transplantation by using haplo-identical DLIs to promote the associated antileukemic effect while minimizing the possibility of permanent engraftment and associated GvHD. To achieve only temporary engraftment and to promote disease control we will give fludarabine immunosuppression prior to the DLI. We anticipate the infusion of HLA-mismatched donor lymphocytes in this setting will produce no detectible engraftment or only temporary engraftment, but may result in a strong GvL effect regardless of engraftment outcome. We will select patients for this protocol who fall into the worst category for post-transplant relapse. Specifically, we will enroll patients with acute leukemia or MDS relapsing within 6 months of transplant, of which less than 5% survive beyond a year from relapse.
Conditions Studied
Interventions
- DEVICE Miltenyi Magnetic cell sorter for CD3
Study Locations (1)
Maryland
- National Institutes of Health - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 8 participants |
| Start Date | 2009-02 |
| Est. Completion | 2014-09 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00859586
The ClinicalTrials.gov registry entry for NCT00859586 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 8 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 116-participant average among 30 other Leukemia, Myeloid, Acute trials with a reported enrollment target (93% lower). The listed sponsor is National Heart, Lung, and Blood Institute (NHLBI), which has 501 total studies on file at ClinicalTrials.gov.
The record links to 3 conditions, with Leukemia, Myeloid, Acute appearing as the primary indexed condition, and to 1 intervention - of which Miltenyi Magnetic cell sorter for CD3 is the first listed.
NCT00859586 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.
Frequently Asked Questions
What is clinical trial NCT00859586 about?
NCT00859586 is a clinical study titled "Mismatched Donor Lymphocyte Infusions for Relapsed Disease Following Allogeneic Stem Cell Transplantation". Patients receiving allogeneic stem cell transplantation for hematological malignancies who suffer a relapse of their disease post-transplant have limited treatment options and a poor prognosis. With the exception of patients with chronic leukemias who may achieve prolonged remissions after donor lym...
What is the current status of trial NCT00859586?
This trial is currently completed. It is a NA study. The enrollment target is 8 participants. The study started on 2009-02. Estimated completion is 2014-09.
What conditions does trial NCT00859586 study?
This clinical trial studies the following conditions: Leukemia, Myeloid, Acute, Leukemia, Lymphoblastic, Acute, Leukemia, Myelocytic, Chronic.
What interventions are being tested in trial NCT00859586?
The interventions under investigation include: Miltenyi Magnetic cell sorter for CD3 (DEVICE).
Who is sponsoring clinical trial NCT00859586?
This trial is sponsored by National Heart, Lung, and Blood Institute (NHLBI), which has 501 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00859586 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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