Clinical trialNCT04070781TerminatedPhase 1Interventional

Itacitinib and Tocilizumab for Steroid Refractory Acute Graft Versus Host Disease

SponsorColumbia UniversityEnrollment1Graft Vs Host DiseaseSteroid Refractory GVHD

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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

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Investigators

The overall officials registered on this study. Names that resolve to a FindMyKOL profile link to it; the rest are shown as registered.

Markus Mapara, MD
Columbia University
Principal Investigator
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A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

2 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States

Columbia University Irving Medical Center
New York, New York, United States
Weill Cornell Medical College - New York Presbyterian Hospital
New York, New York, United States

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

ItacitinibTocilizumab →

Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 20 Jan 2020
Primary completion: 13 Dec 2021
Completion: 13 Dec 2021
Last update posted: 4 Jun 2024
Registered enrollment: 1
Registry id: NCT04070781

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; FindMyKOL does not interpret them.