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NCT03018223 · ClinicalTrials.gov registry record · Phase 1
Calcineurin Inhibitor-Free GVHD Prevention Regimen After Related Haplo PBSCT
A Phase 1 study, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
- Completed
- Registry status
- Phase 1
- Development phase
- 32
- Enrollment target
NCT03018223: Completed Phase 1 study, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
NCT03018223 is a Phase 1 study that has completed, run by H. Lee Moffitt Cancer Center and Research Institute. The registered enrollment target is 32 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (47% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03018223, a Phase 1 study, has completed, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 32 participants
- Enrollment target
Study Summary
The purpose of this study is to find out if a combination of drugs (these are called: cyclophosphamide, sirolimus, and mycophenolate mofetil) will protect participants better against graft vs. host disease (GVHD) after receiving a hematopoietic cell transplant from a related partially matched (haploidentical) donor. As part of the treatment for their blood cancer, participants need a hematopoietic cell transplantation (HCT) to improve their chances of cure. In any HCT, after the stem cell infusion is given, a combination of drugs is needed to prevent GVHD and facilitate acceptance of the graft.
Primary Outcome
Cumulative incidence of grade II-IV acute GVHD by day 100 after HCT. Acute GVHD organ staging and assessment of overall grade will use standard consensus criteria. The cumulative incidence of acute and chronic GVHD will be estimated, considering malignancy relapse and non-relapse death as competing risk events.
Interventions
- DRUG Cyclophosphamide
- DRUG Fludarabine
- DRUG Busulfan
- RADIATION Total body irradiation (TBI)
- PROCEDURE Peripheral Blood Hematopoietic Cell Transplantation (HCT)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 32 participants |
| Start Date | 2017-01-31 |
| Est. Completion | 2021-03-18 |
| Phase | Phase 1 |
What the finished NCT03018223 record still lists
NCT03018223 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 32 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (47% lower).
The record links to 0 conditions, and to 5 interventions - of which Cyclophosphamide is the first listed.
NCT03018223 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03018223 about?
NCT03018223 is a clinical study titled "Calcineurin Inhibitor-Free GVHD Prevention Regimen After Related Haplo PBSCT". The purpose of this study is to find out if a combination of drugs (these are called: cyclophosphamide, sirolimus, and mycophenolate mofetil) will protect participants better against graft vs. host disease (GVHD) after receiving a hematopoietic cell transplant from a related partially matched (haplo...
What is the current status of trial NCT03018223?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 32 participants. The study started on 2017-01-31. Estimated completion is 2021-03-18.
What interventions are being tested in trial NCT03018223?
The interventions under investigation include: Cyclophosphamide (DRUG), Fludarabine (DRUG), Busulfan (DRUG), Total body irradiation (TBI) (RADIATION), Peripheral Blood Hematopoietic Cell Transplantation (HCT) (PROCEDURE).
Who is sponsoring clinical trial NCT03018223?
This trial is sponsored by H. Lee Moffitt Cancer Center and Research Institute, which has 502 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03018223's enrollment target sits among peer trials
32 1296th of 2000 higher than 679 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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