Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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 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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00061581
The ClinicalTrials.gov registry entry for NCT00061581 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 14 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 285-participant average among 173 other Myelodysplastic Syndromes trials with a reported enrollment target (95% 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 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 1 study location spanning 1 distinct geographic area - top geographies include 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
Similar trials for Myelodysplastic Syndromes
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
-
A Pilot, Open-Label Study of Luspatercept for Patients With Lower Risk Myelodysplastic Syndromes (MDS)
RECRUITING · Phase 2
-
Eltrombopag as a Novel Therapeutic Approach for Low-risk MDS and CMML With TET2 Mutations
RECRUITING · Phase 2
-
Luspatercept for Anemia in Lower Risk MDS or Non-proliferative MDS/MPN Neoplasms
RECRUITING · Phase 2
-
A Multi-phase Study of ASTX030 (Azacitidine and Cedazuridine) in Myeloid Neoplasm Alone or in Combination With Venetoclax in AML (AZTOUND Study)
RECRUITING · Phase 2
-
Ascorbate in Myelodysplastic Syndrome
RECRUITING · Phase 2
-
A Study of Momelotinib in Participants With Low-risk Myelodysplastic Syndrome
RECRUITING · Phase 2
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.