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NCT00061581 · ClinicalTrials.gov registry record · Phase 2
Experimental Bone Marrow Transplant Protocol
A Phase 2 study of Myelodysplastic Syndromes and Chronic Myeloid Leukemia, sponsored by National Heart, Lung, and Blood Institute (NHLBI).
- Completed
- Registry status
- Phase 2
- Development phase
- 14
- Enrollment target
- 1
- Study location
NCT00061581: Completed Phase 2 study of Myelodysplastic Syndromes and Chronic Myeloid Leukemia, sponsored by National Heart, Lung, and Blood Institute (NHLBI).
NCT00061581 is a Phase 2 study of Myelodysplastic Syndromes and Chronic Myeloid Leukemia that has completed, run by National Heart, Lung, and Blood Institute (NHLBI). The registered enrollment target is 14 participants, below the 285-participant average among 173 other Myelodysplastic Syndromes trials with a reported enrollment target (95% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00061581, a Phase 2 study of Myelodysplastic Syndromes and Chronic Myeloid Leukemia, has completed, sponsored by National Heart, Lung, and Blood Institute (NHLBI).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 14 participants
- Enrollment target
- 1
- Study location
Study Summary
Bone marrow transplantation (BMT) is a risky procedure. If doctors could reduce the complications, BMT would be safer to use for a wider range of conditions. The purposes of this study are * to prevent graft rejection by increasing the amount of immunosuppression and by giving some lymphocytes from the donor before transplant; * to prevent graft-versus-host disease (GVHD) by transplanting T-cell depleted stem cells; * to improve the immune effect against residual leukemia by the add-back of donor lymphocytes before transplant and six or more weeks after transplant. Beyond the standard transplant protocol, study participants will undergo additional procedures. First, along with total body irradiation, patients will receive two drugs (a high dose of cyclophosphamide and fludarabine) to suppress immunity and prevent rejection of the transplant. Second, four days before the transplant, patients will be given donor lymphocytes that have been irradiated to make them incapable of causing GVHD. On the day of the transplant, patients will receive an infusion of T-cell depleted bone marrow stem cells. Finally, patients will receive two doses of add-back donor T-cells (45 and 100 days post transplant) and the immunosuppressive drug cyclosporine starting on day 44 until about six months after transplant. Study participants must be between the ages of 10 and 56 and have a family member who is a suitable stem cell donor match.
Conditions Studied
Interventions
- DEVICE Isolex 300i Stem Cell Selection
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center, 9000 Rockville Pike - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 14 participants |
| Start Date | 2003-05-19 |
| Est. Completion | 2017-06-14 |
| Phase | Phase 2 |
What the finished NCT00061581 record still lists
NCT00061581 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 14 participants, a relatively small participant target, below the 285-participant average among 173 other Myelodysplastic Syndromes trials with a reported enrollment target (95% lower).
The record links to 5 conditions, with Myelodysplastic Syndromes appearing as the primary indexed condition, and to 1 intervention - of which Isolex 300i Stem Cell Selection is the first listed.
NCT00061581 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT00061581 about?
NCT00061581 is a clinical study titled "Experimental Bone Marrow Transplant Protocol". Bone marrow transplantation (BMT) is a risky procedure. If doctors could reduce the complications, BMT would be safer to use for a wider range of conditions. The purposes of this study are * to prevent graft rejection by increasing the amount of immunosuppression and by giving some lymphocytes from...
What is the current status of trial NCT00061581?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 14 participants. The study started on 2003-05-19. Estimated completion is 2017-06-14.
What conditions does trial NCT00061581 study?
This clinical trial studies the following conditions: Myelodysplastic Syndromes, Chronic Myeloid Leukemia, Acute Lymphocytic Leukemia, Myeloproliferative Disorders, Acute Myelocytic Leukemia.
What interventions are being tested in trial NCT00061581?
The interventions under investigation include: Isolex 300i Stem Cell Selection (DEVICE).
Who is sponsoring clinical trial NCT00061581?
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 NCT00061581 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT00061581's enrollment target sits among peer trials
14 154th of 173 higher than 17 of 173 other Myelodysplastic Syndromes trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Myelodysplastic Syndromes trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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