Itacitinib and Tocilizumab for Steroid Refractory Acute Graft Versus Host Disease

Part of paid clinical trials in New York, New York.

Sponsor
Columbia University
Study ID
NCT04070781
Phase
PHASE1
Status
Terminated

Conditions

  • Graft Vs Host Disease
  • Steroid Refractory GVHD

Eligibility Criteria

Sex
ALL
Age
18 Years - 99 Years
Healthy Volunteers
Not accepted

Interventions

  • Itacitinib — DRUG
    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
  • Tocilizumab — DRUG
    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

Study Details

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

Key Dates

Start date
Jan 20, 2020
Status verified
May 2024
Primary completion
Dec 13, 2021
Completion
Dec 13, 2021

Study Design

Enrollment
1 participants (actual)
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Itacitinib + Tocilizumab
    A dose de-escalation design will be used to identify the MTD of both itacitinib and tocilizumab when given in combination. The following two levels will be tested with at least 6 patients per dose: * Dose level 1: Itacitinib 200 mg daily + tocilizumab 8mg/kg on cycle 1, day 1 (can repeat cycle 2 day 1 if Partial Response (PR) - Starting dose level * Dose level -1: Itacitinib 200 mg daily + tocilizumab 4mg/kg on cycle 1, day 1 (can repeat cycle 2 day 1 if Partial Response (PR) - Dose De-escalation level Itacitinib will be given daily in 28-day long cycles, tocilizumab will be given every 4 weeks in 28-day cycles.
  • Experimental: Dose Expansion
    Once the MTD is determined, an additional 10 patients as an expansion cohort to further define the safety profile of the combination and estimate its response rate.

Primary Outcome Measure

MTD of Tocilizumab IV infusion when given with Itacitinib [ Time Frame: 28 - 35 days after the End of Treatment (EOT) or the date of the last dose of the study drug ]

Locations (2)

FacilityCityStateZIPSite coordinators
Columbia University Irving Medical CenterNew YorkNew York10032-
Weill Cornell Medical College - New York Presbyterian HospitalNew YorkNew York10065-

Find similar trials in New York, NY

By research site
Columbia University Irving Medical Center· New York, NYWeill Cornell Medical College - New York Presbyterian Hospital· New York, NY

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