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NCT00001748 · ClinicalTrials.gov registry record · Phase 1
HLA-Mismatched Peripheral Blood Mobilized Hematopoietic Precursor Cell Transplantation for Hematological Malignancies
A Phase 1 study, sponsored by National Heart, Lung, and Blood Institute (NHLBI).
- Completed
- Registry status
- Phase 1
- Development phase
- 35
- Enrollment target
NCT00001748 is a Phase 1 study that has completed, run by National Heart, Lung, and Blood Institute (NHLBI). The registered enrollment target is 35 participants.
The verdict
NCT00001748, a Phase 1 study, has completed, sponsored by National Heart, Lung, and Blood Institute (NHLBI).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 35 participants
- Enrollment target
Study Summary
Many patients with hematological malignancies potentially curable by bone marrow transplantation are not considered for transplantation because an HLA identical family or unrelated donor is unavailable. For these patients the only curative option is a transplant from a partially matched family donor. Such transplants are feasible but are less successful than matched sibling donor transplants. The main problems with mismatched transplants are graft rejection, graft-vs-host disease, and regimen-related mortality. This restricts the use of mismatched transplants to patients less than 45 years at high risk of dying from the hematological malignancy. This protocol evaluates a new preparative regimen designed to ensure stem cell engraftment by increased immunosuppression, followed by a G-CSF mobilized T cell depleted, stem cell rich, peripheral blood progenitor cell (PBPC) transplant from a mismatched related donor in patients with high risk hematological malignancies. This phase I study evaluates engraftment and GVHD following T cell depleted, HLA-mismatched PBPC transplants. Stopping rules will be used to make modifications to the protocol in the event of graft failure. The end points of the study are graft take, acute and chronic GVHD, leukemic relapse, transplant-related mortality, death and leukemia-free survival. Patients will be followed up for 5 years. It is planned to treat up to 35 patients aged between 10 and 45 years.
Interventions
- PROCEDURE Peripheral blood progenitor cell transplant
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 35 participants |
| Start Date | 1998-06 |
| Est. Completion | 2000-05 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00001748
The ClinicalTrials.gov registry entry for NCT00001748 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 35 participants, a figure that helps gauge the scale of data the investigators plan to collect. 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 0 conditions, and to 1 intervention - of which Peripheral blood progenitor cell transplant is the first listed.
NCT00001748 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00001748 about?
NCT00001748 is a clinical study titled "HLA-Mismatched Peripheral Blood Mobilized Hematopoietic Precursor Cell Transplantation for Hematological Malignancies". Many patients with hematological malignancies potentially curable by bone marrow transplantation are not considered for transplantation because an HLA identical family or unrelated donor is unavailable. For these patients the only curative option is a transplant from a partially matched family donor...
What is the current status of trial NCT00001748?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 35 participants. The study started on 1998-06. Estimated completion is 2000-05.
What interventions are being tested in trial NCT00001748?
The interventions under investigation include: Peripheral blood progenitor cell transplant (PROCEDURE).
Who is sponsoring clinical trial NCT00001748?
This trial is sponsored by National Heart, Lung, and Blood Institute (NHLBI), which has 501 total clinical trials registered on ClinicalTrials.gov.
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