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NCT00589602 · ClinicalTrials.gov registry record · Phase 2
T-Cell Depletion, Donor Hematopoietic Stem Cell Transplant (HSCT), and T-Cell Infusions in Treating Patients With Hematologic Cancer or Other Diseases
A Phase 2 study, sponsored by The Cleveland Clinic.
- Terminated
- Registry status
- Phase 2
- Development phase
- 13
- Enrollment target
NCT00589602: Clinical Trial Phase 2 study, sponsored by The Cleveland Clinic.
NCT00589602 is a Phase 2 study that was terminated before completion, run by The Cleveland Clinic. The registered enrollment target is 13 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (90% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00589602, a Phase 2 study, was terminated before completion, sponsored by The Cleveland Clinic.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 13 participants
- Enrollment target
Study Summary
RATIONALE: Giving chemotherapy and total-body irradiation before a donor peripheral blood stem cell transplant helps stop the growth of cancer and abnormal cells and helps stop the patient's immune system from rejecting the donor's stem cells. When stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells. Removing the T cells from the donor cells before transplant may stop this from happening. Giving an infusion of the donor's T cells (donor lymphocyte infusion) after the transplant may help destroy any remaining cancer cells (graft-versus-tumor effect). PURPOSE: This phase II trial is studying T-cell depletion in donor stem cell transplant followed by delayed T cell infusions in treating patients with hematologic cancer or other disease.
Primary Outcome
The complication rate in matched unrelated donor (MUD) allogeneic bone marrow transplant (allo BMT) is known to be high. Graft failure and severe graft versus host disease (GvHD) are the most significant contributors to treatment related mortality (TRM). This treatment regimen will be considered unacceptable if the number of patients that experience TRM is 55% or greater, and effective if TRM is 33% or less.
Interventions
- PROCEDURE allogeneic hematopoietic stem cell transplantation
- PROCEDURE peripheral blood stem cell transplantation
- PROCEDURE peripheral blood lymphocyte therapy
- RADIATION total-body irradiation (TBI)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 13 participants |
| Start Date | 2004-01 |
| Est. Completion | 2014-12 |
| Phase | Phase 2 |
Why NCT00589602 stopped before completion
NCT00589602 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 13 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (90% lower).
The record links to 0 conditions, and to 4 interventions - of which allogeneic hematopoietic stem cell transplantation is the first listed.
NCT00589602 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00589602 about?
NCT00589602 is a clinical study titled "T-Cell Depletion, Donor Hematopoietic Stem Cell Transplant (HSCT), and T-Cell Infusions in Treating Patients With Hematologic Cancer or Other Diseases". RATIONALE: Giving chemotherapy and total-body irradiation before a donor peripheral blood stem cell transplant helps stop the growth of cancer and abnormal cells and helps stop the patient's immune system from rejecting the donor's stem cells. When stem cells from a donor are infused into the patien...
What is the current status of trial NCT00589602?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 13 participants. The study started on 2004-01. Estimated completion is 2014-12.
What interventions are being tested in trial NCT00589602?
The interventions under investigation include: allogeneic hematopoietic stem cell transplantation (PROCEDURE), peripheral blood stem cell transplantation (PROCEDURE), peripheral blood lymphocyte therapy (PROCEDURE), total-body irradiation (TBI) (RADIATION).
Who is sponsoring clinical trial NCT00589602?
This trial is sponsored by The Cleveland Clinic, which has 688 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00589602's enrollment target sits among peer trials
13 1947th of 2000 higher than 53 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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