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NCT03755414 · ClinicalTrials.gov registry record · Phase 1
Study of Itacitinib for the Prophylaxis of Graft-Versus-Host Disease and Cytokine Release Syndrome After T-cell Replete Haploidentical Peripheral Blood Hematopoietic Cell Transplantation
A Phase 1 study of Myelodysplastic Syndromes and Non-Hodgkin Lymphoma, sponsored by Washington University School of Medicine.
- Completed
- Registry status
- Phase 1
- Development phase
- 55
- Enrollment target
- 1
- Study location
NCT03755414: Completed Phase 1 study of Myelodysplastic Syndromes and Non-Hodgkin Lymphoma, sponsored by Washington University School of Medicine.
NCT03755414 is a Phase 1 study of Myelodysplastic Syndromes and Non-Hodgkin Lymphoma that has completed, run by Washington University School of Medicine. The registered enrollment target is 55 participants, below the 285-participant average among 173 other Myelodysplastic Syndromes trials with a reported enrollment target (81% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03755414, a Phase 1 study of Myelodysplastic Syndromes and Non-Hodgkin Lymphoma, has completed, sponsored by Washington University School of Medicine.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 55 participants
- Enrollment target
- 1
- Study location
Study Summary
In this trial, the investigators will begin to explore the possibility that, as in mice, janus kinase inhibitor 1 (JAK1) inhibition with haploidentical-hematopoietic cell transplantation (HCT) may mitigate graft-versus-host-disease (GVHD) and cytokine release syndrome (CRS) while retaining Graft-versus-Leukemia (GVL) and improving engraftment. The purpose of this pilot study is to determine the safety of itacitinib with haplo-hematopoietic cell transplantation (HCT) measured by the effect on engraftment and grade III-IV GVHD.
Primary Outcome
Failure to engraft will be defined as failure to achieve absolute neutrophil count \>500 for 3 days by day 35.
Conditions Studied
Interventions
- DRUG Itacitinib
- PROCEDURE Stem cell transplantation
- OTHER Functional Assessment of Cancer Therapy-Bone Marrow Transplant (FACT-BMT)
- OTHER Human Activity Profile
Study Locations (1)
Missouri
- Washington University School of Medicine - St Louis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 55 participants |
| Start Date | 2019-09-04 |
| Est. Completion | 2024-05-26 |
| Phase | Phase 1 |
What the finished NCT03755414 record still lists
NCT03755414 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 55 participants, a relatively small participant target, below the 285-participant average among 173 other Myelodysplastic Syndromes trials with a reported enrollment target (81% lower).
The record links to 5 conditions, with Myelodysplastic Syndromes appearing as the primary indexed condition, and to 4 interventions - of which Itacitinib is the first listed.
NCT03755414 reports a single indexed study location in Missouri.
Frequently Asked Questions
What is clinical trial NCT03755414 about?
NCT03755414 is a clinical study titled "Study of Itacitinib for the Prophylaxis of Graft-Versus-Host Disease and Cytokine Release Syndrome After T-cell Replete Haploidentical Peripheral Blood Hematopoietic Cell Transplantation". In this trial, the investigators will begin to explore the possibility that, as in mice, janus kinase inhibitor 1 (JAK1) inhibition with haploidentical-hematopoietic cell transplantation (HCT) may mitigate graft-versus-host-disease (GVHD) and cytokine release syndrome (CRS) while retaining Graft-ver...
What is the current status of trial NCT03755414?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 55 participants. The study started on 2019-09-04. Estimated completion is 2024-05-26.
What conditions does trial NCT03755414 study?
This clinical trial studies the following conditions: Myelodysplastic Syndromes, Non-Hodgkin Lymphoma, Acute Myelogenous Leukemia, Acute Lymphocytic Leukemia, Hodgkin Disease.
What interventions are being tested in trial NCT03755414?
The interventions under investigation include: Itacitinib (DRUG), Stem cell transplantation (PROCEDURE), Functional Assessment of Cancer Therapy-Bone Marrow Transplant (FACT-BMT) (OTHER), Human Activity Profile (OTHER).
Who is sponsoring clinical trial NCT03755414?
This trial is sponsored by Washington University School of Medicine, which has 1,502 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03755414 being conducted?
This trial has 1 study location across Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT03755414's enrollment target sits among peer trials
55 81st of 173 higher than 92 of 173 other Myelodysplastic Syndromes trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Myelodysplastic Syndromes 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.
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