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NCT03128359 · ClinicalTrials.gov registry record · Phase 2
High Dose Cyclophosphamide, Tacrolimus, and Mycophenolate Mofetil in Preventing Graft Versus Host Disease in Patients With Hematological Malignancies Undergoing Myeloablative or Reduced Intensity Donor Stem Cell Transplant
A Phase 2 study, sponsored by City of Hope Medical Center.
- Completed
- Registry status
- Phase 2
- Development phase
- 38
- Enrollment target
NCT03128359: Completed Phase 2 study, sponsored by City of Hope Medical Center.
NCT03128359 is a Phase 2 study that has completed, run by City of Hope Medical Center. The registered enrollment target is 38 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (71% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03128359, a Phase 2 study, has completed, sponsored by City of Hope Medical Center.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 38 participants
- Enrollment target
Study Summary
This pilot phase II trial studies how well high dose cyclophosphamide, tacrolimus, and mycophenolate mofetil work in preventing graft versus host disease in patients with hematological malignancies undergoing myeloablative or reduced intensity donor stem cell transplant. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells (called graft versus host disease). Giving high dose cyclophosphamide, tacrolimus, and mycophenolate mofetil after the transplant may stop this from happening.
Primary Outcome
Estimates will be calculated using the Kaplan-Meier method, Greenwood formula will be used to calculate standard error (SE), and log-log transformation method will be used to construct 95% confidence intervals. Graft versus host disease (GVHD, acute and chronic), disease status and vital status will be monitored per clinical standard operating procedure. For this endpoint failure is defined as the first occurrence of grade 3 or 4 acute GVHD, or moderate/severe chronic GVHD, or disease relapse (f
Interventions
- DRUG Cyclophosphamide
- DRUG Busulfan
- OTHER Laboratory Biomarker Analysis
- DRUG Fludarabine Phosphate
- PROCEDURE Hematopoietic Cell Transplantation
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 38 participants |
| Start Date | 2017-05-30 |
| Est. Completion | 2021-09-15 |
| Phase | Phase 2 |
What the finished NCT03128359 record still lists
NCT03128359 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 38 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (71% lower).
The record links to 0 conditions, and to 5 interventions - of which Cyclophosphamide is the first listed.
NCT03128359 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03128359 about?
NCT03128359 is a clinical study titled "High Dose Cyclophosphamide, Tacrolimus, and Mycophenolate Mofetil in Preventing Graft Versus Host Disease in Patients With Hematological Malignancies Undergoing Myeloablative or Reduced Intensity Donor Stem Cell Transplant". This pilot phase II trial studies how well high dose cyclophosphamide, tacrolimus, and mycophenolate mofetil work in preventing graft versus host disease in patients with hematological malignancies undergoing myeloablative or reduced intensity donor stem cell transplant. Sometimes the transplanted c...
What is the current status of trial NCT03128359?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 38 participants. The study started on 2017-05-30. Estimated completion is 2021-09-15.
What interventions are being tested in trial NCT03128359?
The interventions under investigation include: Cyclophosphamide (DRUG), Busulfan (DRUG), Laboratory Biomarker Analysis (OTHER), Fludarabine Phosphate (DRUG), Hematopoietic Cell Transplantation (PROCEDURE).
Who is sponsoring clinical trial NCT03128359?
This trial is sponsored by City of Hope Medical Center, which has 582 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03128359's enrollment target sits among peer trials
38 1467th of 2000 higher than 517 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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