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NCT01858740 · ClinicalTrials.gov registry record · Phase 2
Selective Depletion of CD45RA+ T Cells From Allogeneic Peripheral Blood Stem Cell Grafts in Preventing GVHD in Children
A Phase 2 study, sponsored by Fred Hutchinson Cancer Center.
- Completed
- Registry status
- Phase 2
- Development phase
- 20
- Enrollment target
NCT01858740: Completed Phase 2 study, sponsored by Fred Hutchinson Cancer Center.
NCT01858740 is a Phase 2 study that has completed, run by Fred Hutchinson Cancer Center. The registered enrollment target is 20 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (85% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01858740, a Phase 2 study, has completed, sponsored by Fred Hutchinson Cancer Center.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 20 participants
- Enrollment target
Study Summary
This phase II trial studies how well T cell depleted donor peripheral blood stem cell transplant works in preventing graft-versus-host disease in younger patients with high risk hematologic malignancies. Giving chemotherapy and total-body irradiation before a donor peripheral blood stem cell transplant helps stop the growth of cancer cells. It may also stop the patient's immune system from rejecting the donor's stem cells. When the healthy 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 a subset of the T cells from the donor cells before transplant may stop this from happening.
Primary Outcome
Graft failure defined as failure to reach ANC of \>500/uL for 3 consecutive days by day 28, or irreversible decrease in ANC to \<100 after an established donor graft. A reduction in ANC as result of relapse is not considered graft failure
Interventions
- OTHER Laboratory Biomarker Analysis
- DRUG Fludarabine Phosphate
- PROCEDURE Peripheral Blood Stem Cell Transplantation
- DRUG Methotrexate
- PROCEDURE Allogeneic Hematopoietic Stem Cell Transplantation
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2014-04-10 |
| Est. Completion | 2023-07-30 |
| Phase | Phase 2 |
What the finished NCT01858740 record still lists
NCT01858740 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (85% lower).
The record links to 0 conditions, and to 5 interventions - of which Laboratory Biomarker Analysis is the first listed.
NCT01858740 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01858740 about?
NCT01858740 is a clinical study titled "Selective Depletion of CD45RA+ T Cells From Allogeneic Peripheral Blood Stem Cell Grafts in Preventing GVHD in Children". This phase II trial studies how well T cell depleted donor peripheral blood stem cell transplant works in preventing graft-versus-host disease in younger patients with high risk hematologic malignancies. Giving chemotherapy and total-body irradiation before a donor peripheral blood stem cell transpl...
What is the current status of trial NCT01858740?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 20 participants. The study started on 2014-04-10. Estimated completion is 2023-07-30.
What interventions are being tested in trial NCT01858740?
The interventions under investigation include: Laboratory Biomarker Analysis (OTHER), Fludarabine Phosphate (DRUG), Peripheral Blood Stem Cell Transplantation (PROCEDURE), Methotrexate (DRUG), Allogeneic Hematopoietic Stem Cell Transplantation (PROCEDURE).
Who is sponsoring clinical trial NCT01858740?
This trial is sponsored by Fred Hutchinson Cancer Center, which has 483 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01858740's enrollment target sits among peer trials
20 1805th of 2000 higher than 107 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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