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NCT02891603 · ClinicalTrials.gov registry record · Phase 1
A Phase I/II GVHD Prevention Trial Combining Pacritinib With Sirolimus-Based Immune Suppression
A Phase 1 study of Graft Vs Host Disease and GvHD, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
- Completed
- Registry status
- Phase 1
- Development phase
- 40
- Enrollment target
- 2
- Study locations
NCT02891603: Completed Phase 1 study of Graft Vs Host Disease and GvHD, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
NCT02891603 is a Phase 1 study of Graft Vs Host Disease and GvHD that has completed, run by H. Lee Moffitt Cancer Center and Research Institute. The registered enrollment target is 40 participants, below the 137-participant average among 36 other Graft Vs Host Disease trials with a reported enrollment target (71% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02891603, a Phase 1 study of Graft Vs Host Disease and GvHD, has completed, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 40 participants
- Enrollment target
- 2
- Study locations
Study Summary
The purpose of this study is to examine a new approach to preventing a serious problem after transplant called graft vs. host disease (abbreviated as GVHD). This is a 3 arm sequential phase I/II, study of Pacritinib with Sirolimus and Tacrolimus (PAC/SIR/TAC) for the prevention of acute GVHD after matched related and unrelated allogeneic hematopoietic cell transplantation (alloHCT).
Primary Outcome
STAT3 activity in circulating CD4+ T-cells. This is equivalent to 5.5 tablespoons of blood for each assessment. Peripheral blood mononuclear cells (PBMC) will be isolated by Ficoll density gradient. PBMCs will be stimulated with IL-6 for 20 minutes to activate STAT3. Phosphoproteins will be analyzed within T-cells by flow cytometry. Result reported is %pSTAT3+CD4+T cells at day +21.
Conditions Studied
Interventions
- DRUG Sirolimus
- DRUG Pacritinib
- DRUG Tacrolimus
- PROCEDURE Allogenic hematopoietic cell transplant (alloHCT)
Study Locations (2)
Florida
- H. Lee Moffitt Cancer Center and Research Institute - Tampa
Minnesota
- University of Minnesota - Minneapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2017-06-08 |
| Est. Completion | 2022-04-18 |
| Phase | Phase 1 |
What the finished NCT02891603 record still lists
NCT02891603 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 137-participant average among 36 other Graft Vs Host Disease trials with a reported enrollment target (71% lower).
The record links to 2 conditions, with Graft Vs Host Disease appearing as the primary indexed condition, and to 4 interventions - of which Sirolimus is the first listed.
NCT02891603 reports a single indexed study location in Florida, Minnesota.
Frequently Asked Questions
What is clinical trial NCT02891603 about?
NCT02891603 is a clinical study titled "A Phase I/II GVHD Prevention Trial Combining Pacritinib With Sirolimus-Based Immune Suppression". The purpose of this study is to examine a new approach to preventing a serious problem after transplant called graft vs. host disease (abbreviated as GVHD). This is a 3 arm sequential phase I/II, study of Pacritinib with Sirolimus and Tacrolimus (PAC/SIR/TAC) for the prevention of acute GVHD after ...
What is the current status of trial NCT02891603?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 40 participants. The study started on 2017-06-08. Estimated completion is 2022-04-18.
What conditions does trial NCT02891603 study?
This clinical trial studies the following conditions: Graft Vs Host Disease, GvHD.
What interventions are being tested in trial NCT02891603?
The interventions under investigation include: Sirolimus (DRUG), Pacritinib (DRUG), Tacrolimus (DRUG), Allogenic hematopoietic cell transplant (alloHCT) (PROCEDURE).
Who is sponsoring clinical trial NCT02891603?
This trial is sponsored by H. Lee Moffitt Cancer Center and Research Institute, which has 502 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02891603 being conducted?
This trial has 2 study locations across Florida, Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT02891603's enrollment target sits among peer trials
40 21st of 36 higher than 14 of 36 other Graft Vs Host Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Graft Vs Host Disease 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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