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: Clinical Trial Phase 1 study, sponsored by Columbia University.
NCT04070781 is a Phase 1 study that was terminated before completion, run by Columbia University. The registered enrollment target is 1 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
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
Primary Outcome
Maximum Tolerated Dose (MTD) is the highest dose of a drug or treatment that does not cause unacceptable side effects.
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 |
Why NCT04070781 stopped before completion
NCT04070781 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 1 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 2 interventions - of which Itacitinib is the first listed.
NCT04070781 does not publish any study locations in the registry export this page uses.
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
How this trial's enrollment target compares
Where NCT04070781's enrollment target sits among peer trials
1 2001st of 2000 the lowest 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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI