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Itacitinib and Tocilizumab for Steroid Refractory Acute Graft Versus Host Disease

NCT04070781 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 1

Last updated 2024-06-04

No results posted yet for this 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

Conditions

  • Steroid Refractory GVHD
  • Graft Vs Host Disease

Interventions

DRUG

Itacitinib

Itacitinib is a novel, potent, and selective inhibitor of the Janus Kinase (JAK) family of protein tyrosine kinases (TYKs) with selectivity for Janus Kinase 1 (JAK1). Itacitinib is an investigational product. Itacitinib 200 mg daily in 28-day long cycles

DRUG

Tocilizumab

Tocilizumab is a biologic medication currently approved to treat adults with moderately to severely active rheumatoid arthritis (RA), adults with giant cell arteritis (GCA), and children ages two and above with Polyarticular Juvenile Idiopathic Arthritis (PJIA) or Systemic Juvenile Idiopathic Arthritis (SJIA). Tocilizumab blocks the inflammatory protein interleukin 6 (IL-6). This improves joint pain and swelling from arthritis and other symptoms caused by inflammation. Tocilizumab 4 or 8mg/kg cycle 1 day 1 every 4 weeks in 28-day cycles

Sponsors & Collaborators

Principal Investigators

  • Markus Mapara, MD · Columbia University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-01-20
Primary Completion
2021-12-13
Completion
2021-12-13
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04070781 on ClinicalTrials.gov