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NCT00001623 · ClinicalTrials.gov registry record · NA
Bone Marrow Transplant Studies for Safe and Effective Treatment of Leukemia
A NA study, sponsored by National Heart, Lung, and Blood Institute (NHLBI).
- Completed
- Registry status
- NA
- Development phase
- 41
- Enrollment target
NCT00001623: Completed NA study, sponsored by National Heart, Lung, and Blood Institute (NHLBI).
NCT00001623 is a NA study that has completed, run by National Heart, Lung, and Blood Institute (NHLBI). The registered enrollment target is 41 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00001623, a NA study, has completed, sponsored by National Heart, Lung, and Blood Institute (NHLBI).
- COMPLETED
- Registry status
- NA
- Development phase
- 41 participants
- Enrollment target
Study Summary
Bone marrow transplants (BMT) are one of the accepted therapies used to treat leukemia. However, BMT have risks of complications. One potentially life-threatening complication is known as graft-versus-host disease (GVHD). The GVHD is a reaction caused by an incompatibility between donor cells and recipient cells. Antigens found on the recipient s cells are recognized by the donor s transplanted white blood cell lymphocytes. These lymphocytes begin attacking the recipient s cells and tissues and may lead to death. One of the most effective ways to prevent this reaction is to remove the lymphocytes from the transplanted marrow. Unfortunately, without lymphocytes the recipient s immune system will be lowered and may result in a relapse of leukemia or an infection. Researchers have shown they can perform effective BMT by removing the lymphocytes prior to the transplant and then later adding the lymphocytes back. This technique can reduce the potential for GVHD and preserve the graft-versus-leukemia (GVL) effect of the transplant. In this study researchers plan to use peripheral blood with lymphocytes removed rather than bone marrow. In order to increase the number of progenitor cells, the cells responsible for correcting the leukemia, donors will receive doses of G-CSF prior to the transplant. G-CSF (granulocyte colony stimulating factor) is a growth factor that increases the production of progenitor cells in the donor s blood stream. The study will be broken into two parts. The first part of the study will attempt to determine if peripheral blood with lymphocytes removed can prevent GVHD while preserving the GVL effect of the transplant. In the second part of the study, patients that received the transplant will have the lymphocytes added-back on two separate occasions in order reduce the chances of relapse and infection. The study is designed to treat up to 55 patients ages 10 to 60 years and follow their progress for 5 years.
Interventions
- PROCEDURE Allogeneic Bone Marrow Transplant
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 41 participants |
| Start Date | 1997-03-27 |
| Est. Completion | 2017-08-03 |
| Phase | NA |
What the finished NCT00001623 record still lists
NCT00001623 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 41 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 1 intervention - of which Allogeneic Bone Marrow Transplant is the first listed.
NCT00001623 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00001623 about?
NCT00001623 is a clinical study titled "Bone Marrow Transplant Studies for Safe and Effective Treatment of Leukemia". Bone marrow transplants (BMT) are one of the accepted therapies used to treat leukemia. However, BMT have risks of complications. One potentially life-threatening complication is known as graft-versus-host disease (GVHD). The GVHD is a reaction caused by an incompatibility between donor cells and r...
What is the current status of trial NCT00001623?
This trial is currently completed. It is a NA study. The enrollment target is 41 participants. The study started on 1997-03-27. Estimated completion is 2017-08-03.
What interventions are being tested in trial NCT00001623?
The interventions under investigation include: Allogeneic Bone Marrow Transplant (PROCEDURE).
Who is sponsoring clinical trial NCT00001623?
This trial is sponsored by National Heart, Lung, and Blood Institute (NHLBI), which has 501 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00001623's enrollment target sits among peer trials
41 1446th of 2000 higher than 554 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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