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Graft vs Host Disease clinical trials

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NCT ID: NCT05673876 Terminated - Clinical trials for Acute Graft-versus-host Disease

A Study to Assess the Safety and Pharmacokinetics of GDC-8264 in Combination With Standard of Care in Participants With Acute Graft-Versus-Host Disease (aGVHD)

Start date: April 6, 2023
Phase: Phase 1
Study type: Interventional

The primary purpose of the study is to assess the safety and pharmacokinetics (PK) of GDC-8264 in participants with acute graft-versus-host disease (aGVHD).

NCT ID: NCT04934670 Terminated - Clinical trials for Steroid-Refractory Acute Graft Versus Host Disease

A Study to Compare T-Guard vs Ruxolitinib for Treatment of Steroid-Refractory Acute Graft-vs-Host Disease (BMT CTN 2002)

2002
Start date: June 16, 2022
Phase: Phase 3
Study type: Interventional

This is an open-label, randomized, Phase 3, multicenter trial, which has been designed to compare the efficacy and safety of T-Guard to ruxolitinib in patients with Grade III or IV Steroid-Refractory acute Graft-Versus-Host Disease (SR-aGVHD). The primary hypothesis is that T-Guard treatment will improve the Day 28 complete response (CR) rate in patients with Grades III and IV SR-aGVHD compared to ruxolitinib.

NCT ID: NCT04910152 Terminated - Clinical trials for Acute Graft Versus Host Disease

Novel BET Inhibitor PLX51107 for Steroid-Refractory Acute GVHD

Start date: April 19, 2022
Phase: Phase 1/Phase 2
Study type: Interventional

This phase Ib/II trial studies the side effects of PLX51107 in treating steroid-refractory acute graft versus host disease (GVHD). PLX51107 is a novel, potent non-benzodiazepine structured small molecule BET inhibitor with a unique binding mode selective for BRD4 inhibition and a more tolerable side effect profile. PLX51107 may work better in treating steroid-refractory acute GVHD.

NCT ID: NCT04852692 Terminated - Clinical trials for Chronic Graft vs Host Disease

A Study to Investigate the Comparative Effectiveness of Ibrutinib in Steroid Dependent/Refractory cGVHD Participants

Start date: June 21, 2021
Phase:
Study type: Observational

The purpose of this study is to evaluate the effectiveness of ibrutinib compared to conventional salvage treatments in participants with steroid dependent/refractory chronic graft versus host disease (cGVHD) by measuring overall cGVHD response (modified National Institutes of Health [NIH] response defined complete response [CR] and partial response [PR]) at Week 24.

NCT ID: NCT04521777 Terminated - Clinical trials for Acute Graft Versus Host Disease

Studying Changes in Physical Function Measures in Stem Cell Transplant Patients at Risk for Steroid Myopathy

Start date: October 1, 2015
Phase: N/A
Study type: Interventional

This trial investigates the changes in physical and functional tests over time in patients with suspected acute graft versus host disease (from a hematologic stem cell transplant) who started treatment with corticosteroids. Sometimes the transplanted cells from a donor can attack the body's normal cells (called graft-versus-host disease). Steroids are used to treat suspected graft-versus-host disease. Steroid myopathy (muscle weakness and fatigue) is a significant side effect of high dose steroid therapy, and can impair activities of daily of life. The goal of this trial is to learn how patients' physical activities and functions change over time while on GVHD-steroid treatment.

NCT ID: NCT04446182 Terminated - Clinical trials for Chronic Graft-versus-host-disease

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

FLIGHT
Start date: January 29, 2021
Phase: Phase 2
Study type: Interventional

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.

NCT ID: NCT04235036 Terminated - Clinical trials for Graft Vs Host Disease

Ibrutinib and Rituxan for Chronic GVHD

Start date: December 16, 2019
Phase: Phase 2
Study type: Interventional

This is a phase II trial evaluating the safety and efficacy of the combination of Ibrutinib and Rituximab as primary treatment of chronic GVHD. We plan to enroll 35 patients on this study. Patients will be formally monitored monthly for 12 months to evaluate for outcome and safety endpoints. All other assessments will be done at the physician's discretion or institutional standards. All patients, responders and treatment failures, will be followed for a period of one year from the time of initiation of therapy. The primary endpoint will be the proportion of patients that are alive and off all systemic IST at 12 months following initiation of treatment.

NCT ID: NCT04232397 Terminated - Clinical trials for Chronic Graft-versus-host-disease

Anlotinib Treatment in Steroid Depenent/Refractory cGVHD

Start date: April 10, 2020
Phase: Phase 2
Study type: Interventional

This is a single center, single arm, prospective, phase II clinical study. The main purpose of this study is to evaluate the efficacy and safety of anlotinib in the treatment of steroid dependent/refractory chronic graft-versus-host disease (cGVHD) after allogeneic peripheral blood stem cell transplantation (allo HSCT).

NCT ID: NCT04227938 Terminated - Clinical trials for Graft Vs Host Disease

ALPN-101 in Steroid-resistant or Steroid-refractory Acute GVHD

Balance
Start date: May 11, 2020
Phase: Phase 1
Study type: Interventional

The Balance study will assess the safety, tolerability, and efficacy of an investigational drug called ALPN-101 in adults with steroid-resistant or steroid-refractory acute graft versus host disease (aGVHD).

NCT ID: NCT04220632 Terminated - GVHD,Acute Clinical Trials

A Study of IBI377 in Combination With Corticosteroids for the Treatment of First-Line Acute Graft-Versus-Host Disease

Start date: June 18, 2020
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to evaluate itacitinib in combination with corticosteroids as first-line treatment of participants with Grade II to IV acute graft-versus-host disease (aGVHD).