Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT04070781 · ClinicalTrials.gov registry record · Phase 1
Itacitinib and Tocilizumab for Steroid Refractory Acute Graft Versus Host Disease
A Phase 1 study, sponsored by Columbia University.
- Terminated
- Registry status
- Phase 1
- Development phase
- 1
- Enrollment target
NCT04070781 is a Phase 1 study that was terminated before completion, run by Columbia University. The registered enrollment target is 1 participants.
The verdict
NCT04070781, a Phase 1 study, was terminated before completion, sponsored by Columbia University.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 1 participants
- Enrollment target
Study Summary
The study's primary objective is designed to assess the safety and tolerability, and determine the maximum tolerated dose (MTD) of both itacitinib and tocilizumab when given in combination to patients with steroid-refractory acute graft versus host disease (SR-aGVHD). The study's secondary objectives are to: * Estimate the day 28 response rate (ORR) \[complete response (CR), very good partial response (VGPR), and partial response (PR)\] of the combination of itacitinib and tocilizumab for the treatment of SR-aGVHD * Estimate the time to response and duration of response * Estimate the incidence of primary disease relapse while on study treatment * Estimate the incidence of infections including viral reactivation, bacterial infections and fungal infections while on study treatment * Estimate the progression-free survival (PFS), overall survival (OS), non-relapse mortality, GVHD-related mortality of study subjects * Estimate the proportion of patients who successfully discontinue steroids by 6 months and 12 months after therapy initiation
Interventions
- DRUG Itacitinib
- DRUG Tocilizumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1 participants |
| Start Date | 2020-01-20 |
| Est. Completion | 2021-12-13 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04070781
The ClinicalTrials.gov registry entry for NCT04070781 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 1 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Columbia University, which has 958 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Itacitinib is the first listed.
NCT04070781 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04070781 about?
NCT04070781 is a clinical study titled "Itacitinib and Tocilizumab for Steroid Refractory Acute Graft Versus Host Disease". The study's primary objective is designed to assess the safety and tolerability, and determine the maximum tolerated dose (MTD) of both itacitinib and tocilizumab when given in combination to patients with steroid-refractory acute graft versus host disease (SR-aGVHD). The study's secondary objectiv...
What is the current status of trial NCT04070781?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 1 participants. The study started on 2020-01-20. Estimated completion is 2021-12-13.
What interventions are being tested in trial NCT04070781?
The interventions under investigation include: Itacitinib (DRUG), Tocilizumab (DRUG).
Who is sponsoring clinical trial NCT04070781?
This trial is sponsored by Columbia University, which has 958 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.