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NCT01044745 · ClinicalTrials.gov registry record · Phase 2
Rituximab in Preventing Acute Graft-Versus-Host Disease in a Donor Stem Cell Transplant for Hematologic Cancer
A Phase 2 study, sponsored by University of Nebraska.
- Terminated
- Registry status
- Phase 2
- Development phase
- 20
- Enrollment target
NCT01044745: Clinical Trial Phase 2 study, sponsored by University of Nebraska.
NCT01044745 is a Phase 2 study that was terminated before completion, run by University of Nebraska. 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
NCT01044745, a Phase 2 study, was terminated before completion, sponsored by University of Nebraska.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 20 participants
- Enrollment target
Study Summary
This phase II trial is studying how well rituximab works in preventing acute graft-versus-host disease (GVHD) in patients undergoing a donor stem cell transplant for hematologic cancer. Giving chemotherapy and total-body irradiation before a donor 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. The donated stem cells may replace the patient's immune cells and help destroy any remaining cancer cells (graft-versus-tumor effect). Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving a monoclonal antibody, rituximab, together with anti-thymocyte globulin, tacrolimus, and mycophenolate mofetil before and after the transplant may stop this from happening
Primary Outcome
Determined with death as a competing risk. Defined and staged using the 1994 consensus conference modifications of the Glucksberg criteria.
Interventions
- DRUG tacrolimus
- PROCEDURE allogeneic hematopoietic stem cell transplantation
- DRUG rituximab
- DRUG mycophenolate mofetil
- DRUG anti-thymocyte globulin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2009-12-10 |
| Est. Completion | 2017-10-10 |
| Phase | Phase 2 |
Why NCT01044745 stopped before completion
NCT01044745 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 tacrolimus is the first listed.
NCT01044745 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01044745 about?
NCT01044745 is a clinical study titled "Rituximab in Preventing Acute Graft-Versus-Host Disease in a Donor Stem Cell Transplant for Hematologic Cancer". This phase II trial is studying how well rituximab works in preventing acute graft-versus-host disease (GVHD) in patients undergoing a donor stem cell transplant for hematologic cancer. Giving chemotherapy and total-body irradiation before a donor stem cell transplant helps stop the growth of cancer...
What is the current status of trial NCT01044745?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 20 participants. The study started on 2009-12-10. Estimated completion is 2017-10-10.
What interventions are being tested in trial NCT01044745?
The interventions under investigation include: tacrolimus (DRUG), allogeneic hematopoietic stem cell transplantation (PROCEDURE), rituximab (DRUG), mycophenolate mofetil (DRUG), anti-thymocyte globulin (DRUG).
Who is sponsoring clinical trial NCT01044745?
This trial is sponsored by University of Nebraska, which has 407 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01044745'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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