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NCT01028716 · ClinicalTrials.gov registry record · Phase 2
Donor Peripheral Blood Stem Cell Transplant in Treating Patients With Hematologic Malignancies
A Phase 2 study, sponsored by Fred Hutchinson Cancer Center.
- Terminated
- Registry status
- Phase 2
- Development phase
- 46
- Enrollment target
NCT01028716: Clinical Trial Phase 2 study, sponsored by Fred Hutchinson Cancer Center.
NCT01028716 is a Phase 2 study that was terminated before completion, run by Fred Hutchinson Cancer Center. The registered enrollment target is 46 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (65% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01028716, a Phase 2 study, was terminated before completion, sponsored by Fred Hutchinson Cancer Center.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 46 participants
- Enrollment target
Study Summary
This phase II trial studies how well donor peripheral blood stem cell (PBSC) transplant works in treating patients with hematologic malignancies. Cyclophosphamide when added to tacrolimus and mycophenolate mofetil is safe and effective in preventing severe graft-versus-host disease (GVHD) in most patients with hematologic malignancies undergoing transplantation of bone marrow from half-matched (haploidentical) donors. This approach has extended the transplant option to patients who do not have matched related or unrelated donors, especially for patients from ethnic minority groups. The graft contains cells of the donor's immune system which potentially can recognize and destroy the patient's cancer cells (graft-versus-tumor effect). Rejection of the donor's cells by the patient's own immune system is prevented by giving low doses of chemotherapy (fludarabine phosphate and cyclophosphamide) and total-body irradiation before transplant. Patients can experience low blood cell counts after transplant. Using stem cells and immune cells collected from the donor's circulating blood may result in quicker recovery of blood counts and may be more effective in treating the patient's disease than using bone marrow.
Primary Outcome
Cumulative incidence of death without evidence of disease progression at 1 year
Interventions
- DRUG Cyclophosphamide
- BIOLOGICAL Filgrastim
- DRUG Mycophenolate Mofetil
- DRUG Fludarabine Phosphate
- PROCEDURE Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 46 participants |
| Start Date | 2010-05-19 |
| Est. Completion | 2021-10-07 |
| Phase | Phase 2 |
Why NCT01028716 stopped before completion
NCT01028716 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 46 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (65% lower).
The record links to 0 conditions, and to 5 interventions - of which Cyclophosphamide is the first listed.
NCT01028716 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01028716 about?
NCT01028716 is a clinical study titled "Donor Peripheral Blood Stem Cell Transplant in Treating Patients With Hematologic Malignancies". This phase II trial studies how well donor peripheral blood stem cell (PBSC) transplant works in treating patients with hematologic malignancies. Cyclophosphamide when added to tacrolimus and mycophenolate mofetil is safe and effective in preventing severe graft-versus-host disease (GVHD) in most pa...
What is the current status of trial NCT01028716?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 46 participants. The study started on 2010-05-19. Estimated completion is 2021-10-07.
What interventions are being tested in trial NCT01028716?
The interventions under investigation include: Cyclophosphamide (DRUG), Filgrastim (BIOLOGICAL), Mycophenolate Mofetil (DRUG), Fludarabine Phosphate (DRUG), Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation (PROCEDURE).
Who is sponsoring clinical trial NCT01028716?
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 NCT01028716's enrollment target sits among peer trials
46 1286th of 2000 higher than 705 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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