Clinical Trials Logo
  1. Home
  2. Other
  3. NCT04446182

Itacitinib (INCB039110) and Extracorporeal Photopheresis (ECP) for First-Line Treatment in Chronic GVHD — FLIGHT  

Chronic Graft-versus-host-disease Clinical Trial

Official title:
A Phase II Study of Itacitinib (INCB039110) and Extracorporeal Photopheresis (ECP) for First-Line Treatment in Chronic Graft Versus Host Disease (GVHD)

Clinical Trial Summary

An open-label, Phase II trial designed to assess the recommended phase 2 dose (RP2D) of itacitinib in combination ECP and efficacy of the combination after 24 weeks of therapy. The trial will consist of two parts: Part One will assess the RP2D. For dose-finding purposes, the dose limiting toxicity (DLT) evaluation period will be defined as the time from the first dose of itacitinib lead-in (7-day lead-in) to the last day of cycle one combination therapy (Cycle one day 28). Part Two will further describe and characterize the safety and efficacy of the regimen. The RP2D will be determined by a 3+3 dose de-escalation design. Should dose level one be deemed intolerable, enrollment will proceed at dose level -1. The RP2D will be affirmed according to the rules of the 3+3 dose de-escalation scheme. Once an RP2D has been confirmed, Part 2 will open as an expansion cohort. As this study was terminated after enrolling three patients out of an anticipated target accrual of 58, Part Two of this study did not occur.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04446182
Study type Interventional
Source University of Utah
Contact
Status Terminated
Phase Phase 2
Start date January 29, 2021
Completion date January 30, 2023
View Details
See also
  Status Clinical Trial Phase
Active, not recruiting NCT04189432 - Efficacy and Safety of SCM-CGH in Patients With Steroid-Refractory or Dependent Chronic Graft-Versus-Host Disease Phase 2
Terminated NCT03557749 - Monitoring of Immune and Microbial Reconstitution in (HCT) and Novel Immunotherapies
Completed NCT05121142 - Study of Ruxolitinib for Acute and Chronic Graft Versus Host Disease Phase 1
Recruiting NCT04202835 - ATG Plus PTCy vs ATG for CGVHD Prophylaxis Phase 2
Terminated NCT03640481 - Efficacy and Safety of KD025 in Subjects With cGVHD After At Least 2 Prior Lines of Systemic Therapy Phase 2
Completed NCT01036958 - Development and Validation of a Symptom Scale for Children With Chronic Graft-versus-Host Disease
Recruiting NCT04372524 - Biomarker Verification in Pediatric Chronic GvHD: ABLE 2.0 / PTCTC GVH 1901 Study
Active, not recruiting NCT03604692 - A Phase 1/2 Study to Evaluate SNDX- 6352 in Participants With Active cGVHD Phase 1/Phase 2
Recruiting NCT05355675 - The Association of Microbiota Composition With cGVHD After Allo-HSCT
Active, not recruiting NCT04710576 - A Study of Axatilimab at 3 Different Doses in Participants With Chronic Graft Versus Host Disease (cGVHD) Phase 2
Terminated NCT04200365 - A Study of Itacitinib for the Treatment of Chronic Graft Versus Host Disease (cGVHD) Phase 2
Not yet recruiting NCT06263478 - A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Axatilimab Monotherapy in Japanese Participants With Recurrent or Refractory Active Chronic Graft-Versus-Host Disease Phase 3
Not yet recruiting NCT06388564 - A Study to Evaluate the Safety and Efficacy of Axatilimab in Combination With Ruxolitinib in Participants With Newly Diagnosed Chronic Graft-Versus-Host Disease Phase 2
Terminated NCT02123966 - An Open Label Phase II Trial of Topical Sirolimus for the Treatment of Refractory Oral Chronic Graft-versus-Host-Disease Phase 2
Recruiting NCT05692713 - Polyomic Biomarker Verification in Adult Chronic Graft-Versus-Host Disease (ABLE3.0/CTTC2201)
Active, not recruiting NCT05305989 - Extended Treatment and Follow-up of Subjects Treated With Belumosudil in Study KD025-208 or Study KD025-213 Phase 2
Active, not recruiting NCT02340676 - A Phase II Trial of Low-Dose Interleukin-2 (IL-2) Added to Extra-Corporeal Photopheresis for Steroid-Refractory cGVHD Phase 2
Completed NCT04540133 - Dexamethasone Solution and Dexamethasone in Mucolox™ Phase 2
Not yet recruiting NCT03190733 - A Optimal Anti-Thymoglobuline (ATG) Dose Decrease cGVHD But Not Increase Leukemia Relapse for Haplo-HSCT Phase 4
Active, not recruiting NCT04716075 - Acalabrutinib in CLL and MCL Patients Subjected to Allogeneic Hematopoietic Stem Cell Transplantation (alloSCT) Phase 2