Itacitinib for Low Risk GVHD

Status Completed

Clinical Trial Summary

Graft-versus-host disease (GVHD) is treated with high doses of systemic steroids which can lead to serious complications. A new blood test can identify patients whose GVHD is most likely to respond to well to treatment (low risk GVHD). This study will test whether patients with low risk GVHD can be successfully treated without steroids. Patients who participate with this study will be treated with itacitinib instead of steroids. Itacitinib is an experimental drug with an excellent safety record and appears to have activity as a GVHD treatment.

Clinical Trial Description

Patients with newly diagnosed low risk acute GVHD defined as Minnesota standard risk based on symptoms and Ann Arbor 1 GVHD based on biomarkers were eligible if they met all other eligible criteria (see eligibility criteria below). Enrolled patients were required to start treatment within 4 days of confirmation of Ann Arbor 1 status. Treatment consisted of itacitinib 200 mg daily for 28 days. Patients with a clinical response on day 28 were eligible for a second 28 day cycle of itacitinib 200 mg daily. Missed doses could be made up by extending the treatment duration for up to 2 additional weeks. Medications given for GVHD prophylaxis and topical treatments for GVHD were allowed. Supportive care was provided according to institutional standards. Itacitinib was permanently discontinued after any of the following: administration of 56 doses of itacitinib or initiation of systemic corticosteroids or any other systemic treatment for GVHD or patient withdrawal from the study or general or specific changes in the patient's condition render the patient unacceptable for further treatment in the judgment of the investigator OR ten weeks elapsed since the first dose of itacitinib. ;

Study Design

Related Conditions & MeSH terms

Graft vs Host Disease
Graft-versus-host-disease
GVHD
Low Risk Acute Graft-versus-host Disease

Clinical Trial Details

NCT number	NCT03846479
Study type	Interventional
Source	Icahn School of Medicine at Mount Sinai
Contact
Status	Completed
Phase	Phase 2
Start date	March 25, 2019
Completion date	May 11, 2022

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT02942173` - CD45RA Depleted T-cell Infusion for Prevention of Infections After TCRab/CD19-depleted Allo-HSCT	Phase 2/Phase 3
Terminated	`NCT01940796` - Phase I Trial of Brentuximab Vedotin for Refractory Chronic Graft-vs.-Host Disease (GVHD)	Phase 1
Completed	`NCT02066051` - IPL and Meibomian Gland Expression to Treat Ocular Rosacea Ocular GVHD	N/A
Not yet recruiting	`NCT05544448` - In Vitro Effect Study of Interleukin-2 Muteins on Regulatory T Cells of Patients With Different Autoimmune, Allo-immune or Inflammatory Diseases	N/A
Completed	`NCT01295710` - Study of US-ATG-F to Prevent Chronic Graft Versus Host Disease (GVHD)	Phase 3
Not yet recruiting	`NCT06000982` - Comparison of Different Dose of Post-transplantation Cyclophosphamide as Graft Versus Host Disease Prophylaxis	Phase 3
Not yet recruiting	`NCT06075225` - MAP-guided Preemptive Therapy of aGvHD by Ruxolitinib	Phase 2
Active, not recruiting	`NCT03680092` - Comparing Cyclophosphamide and Abatacept With Standard of Care Treatment Following Stem Cell Transplantation	Phase 2
Not yet recruiting	`NCT06083129` - Phase III Study Comparing GVHD Prophylaxis With ATG-thymoglobulin to ATLG-grafalon in Elderly Patients With Acute Myeloid Leukemia or Myelodysplasic Syndrome and Receiving an Allogeneic Hematopoietic Stem Cell Transplantation With a 10/10 HLA Matched Unrelated Donor	Phase 3
Not yet recruiting	`NCT05094765` - Fecal Microbiota Transplant (FMT) Capsule for Improving the Efficacy of GI-aGVHD	Early Phase 1
Active, not recruiting	`NCT05415410` - Proof-of-concept Trial of Apraglutide in GVHD	Phase 2
Completed	`NCT02441075` - 70% Ethanol for Decontamination of CVL Exposed to Calcineurine Inhibitors Version 1.0, 1/9/2014	N/A
Completed	`NCT02588339` - Panobinostat (LBH589): Acute Graft Versus Host Disease (aGVHD) Prevention	Phase 2
Not yet recruiting	`NCT06334367` - Prophylaxis of Graft-versus-host Disease With Anti-CD25 Antibody in Patients Underwent HSCT	Phase 2
Completed	`NCT02891603` - A Phase I/II GVHD Prevention Trial Combining Pacritinib With Sirolimus-Based Immune Suppression	Phase 1/Phase 2
Completed	`NCT02712762` - Ocular Surface Disease in Chronic Graft-Versus-Host Disease (GVHD) Patients
Completed	`NCT03945591` - High-Dose Post-Transplant Cyclophosphamide and Bortezomib (CyBor) for the Prevention of Graft-versus-Host Disease Following Allogeneic Hematopoietic Stem Cell Transplantation (HSCT)	Phase 2
Not yet recruiting	`NCT06411184` - Safety and Efficacy of Treg Cell in the Treatment of GVHD	Phase 1/Phase 2
Terminated	`NCT02338232` - Study of TelmisartanFor the Prevention of Acute GVHD Post Allogeneic Hematopoietic Stem Cell Transplantation	N/A
Completed	`NCT02156479` - Clinical Validation of Lophius Biosciences Kit T-Track® CMV in Allo-HSCT Recipients