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Graft vs Host Disease clinical trials

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NCT ID: NCT05415410 Active, not recruiting - GVHD Clinical Trials

Proof-of-concept Trial of Apraglutide in GVHD

Start date: May 25, 2022
Phase: Phase 2
Study type: Interventional

The aim of this trial is to assess safety and efficacy of apraglutide in subjects with steroid refractory gastrointestinal acute graft versus host disease (aGVHD).

NCT ID: NCT05305989 Active, not recruiting - Clinical trials for Chronic Graft-versus-host-disease

Extended Treatment and Follow-up of Subjects Treated With Belumosudil in Study KD025-208 or Study KD025-213

Start date: February 23, 2022
Phase: Phase 2
Study type: Interventional

Extended Treatment and Follow-up of Subjects Treated with Belumosudil in Study KD025-208 or Study KD025-213

NCT ID: NCT05186857 Active, not recruiting - Clinical trials for Graft-versus-host Disease

Metabolome and Microbiome Impact on Acute GVHD in Recipients of Hematopoietic Transplant

AlloBolome
Start date: January 23, 2023
Phase:
Study type: Observational

Recent published data suggest that specific alterations in intestinal metabolome signature of hematopoietic stem cell transplant (allo-SCT) recipients might influence incidence and severity of acute graft versus host disease (aGVHD). Nevertheless, this possible relationship has not been undoubtedly established, pathophysiologic mechanisms have not been elucidated and possible clinical implications have not been studied. We hypothesized that in the early phase of allo-SCT, specific alterations in faecal metabolome occurred related to loss of intestinal microbiota diversity and disbalance of specific bacterial taxa, and that both alterations determine reduced survival of patients through increased incidence and severity of aGVHD. To test this hypothesis, a prospective multi-center cohort of allo-SCT recipients will had faecal and plasmatic samples collected at predetermined time-points pre&post-allo-SCT, and clinical relevant variables will be prospectively recorded throughout two years posttransplant follow-up. Metabolomic and microbiome analysis will be done to answer objectives of the study. To additionally explore if differential evolving characteristics in the intestinal metabolome and microbiome of donor/recipient sibling pairs influence the incidence and severity of aGVHD, probability of malignancy relapse and early and late mortality an additional cohort of family donors of enrolled patients will also have faecal and plasmatic samples collected and analysed.

NCT ID: NCT05132166 Active, not recruiting - Clinical trials for Graft Vs Host Disease

A Randomized Phase II Study to Compare the Potential Long-Lasting Positive Effect of Decidual Stromal Cells to the Best Available Treatment in Graft Versus Host Disease

Start date: December 22, 2021
Phase: Phase 2
Study type: Interventional

This is an academic open-label, phase II randomized study in patients with steroid resistant severe acute Graft versus host disease (GvHD) who have had allogeneic hematopoietic stem cell transplantation. The main purpose of this study is to compare the efficacy of Decidual Stromal Cells (DSC) with Investigators choice best available treatment (BAT). If randomized to DSC arm, patients will receive 2 infusions in the vein at least one week apart. Additional doses (up to 4 doses) of DSC may be given depending on response.

NCT ID: NCT04976699 Active, not recruiting - Clinical trials for Acute Myeloid Leukemia

CD24Fc for the Prevention of Acute Graft Versus Host Disease (GVHD) Following Myeloablative Hematopoietic Stem Cell Transplantation (HSCT) (MK-7110-005)

CATHY
Start date: January 5, 2021
Phase: Phase 3
Study type: Interventional

The study compares two acute graft-versus-host disease (aGVHD) prophylaxis regimens: CD24Fc vs placebo with the standard GVHD prophylaxis of tacrolimus / methotrexate.

NCT ID: NCT04944043 Active, not recruiting - Clinical trials for Chronic Graft Versus Host Disease

A Study of TQ05105 in Patients With Chronic Graft Versus Host Disease

Start date: June 25, 2021
Phase: Phase 1/Phase 2
Study type: Interventional

This study was a single arm, open label, multicenter phase Ib / II trial in subjects with glucocorticoid refractory / dependent moderate to severe cGVHD.The trial consisted of two phases: phase I for the dose exploration and phase II for the extension study.

NCT ID: NCT04859946 Active, not recruiting - Clinical trials for Hematologic and Lymphocytic Disorder

Itacitinib for the Prevention of Graft Versus Host Disease

Start date: January 11, 2022
Phase: Phase 1
Study type: Interventional

This phase II trial studies if itacitinib plus standard of care treatment may help prevent graft-versus-host-disease (GVHD) in patients who have received an allogeneic (donor) stem cell transplant. An allogeneic transplant uses blood-making cells from a family member or unrelated donor to remove and replace a patient's abnormal blood cells. Sometimes the transplanted cells from a donor can attack the body's normal cells (called graft-versus-host disease). Giving itacitinib with standard of care treatment after the transplant may stop this from happening.

NCT ID: NCT04769648 Active, not recruiting - Clinical trials for Ocular Graft-versus-host Disease

Safety and Efficacy of Pro-ocularâ„¢ 1% in Daily Scleral Lens Wearing Patients With Ocular Graft-versus-Host Disease

Start date: April 15, 2021
Phase: Phase 2/Phase 3
Study type: Interventional

This clinical study seeks to evaluate the safety and efficacy of Pro-ocularâ„¢1% topical gel in patients with ocular Graft-versus-Host Disease who wear scleral lenses daily. This vehicle-controlled trial will evaluate the investigational drug's effect on signs and symptoms of ocular Graft-versus-Host Disease and on the hours of daily comfortable and serviceable scleral lens wear.

NCT ID: NCT04716075 Active, not recruiting - Clinical trials for Chronic Lymphocytic Leukemia

Acalabrutinib in CLL and MCL Patients Subjected to Allogeneic Hematopoietic Stem Cell Transplantation (alloSCT)

ACALLO
Start date: August 19, 2019
Phase: Phase 2
Study type: Interventional

In this phase II multicenter trial we plan to use acalabrutinib before and after allogeneic hematopoietic stem cell transplantation (alloSCT) with reduced intensity conditioning (RIC) in patients with refractory/relapsed MCL and CLL with poor prognostic factors. Acalabrutinib will be used before alloSCT with the intention to reduce tumor burden and after transplant to augment disease control.

NCT ID: NCT04710576 Active, not recruiting - Clinical trials for Chronic Graft-versus-host-disease

A Study of Axatilimab at 3 Different Doses in Participants With Chronic Graft Versus Host Disease (cGVHD)

AGAVE-201
Start date: March 4, 2021
Phase: Phase 2
Study type: Interventional

This is a Phase 2 study to evaluate the efficacy, safety, and tolerability of axatilimab at 3 different dose levels in participants with recurrent or refractory active chronic graft versus host disease (cGVHD) who have received at least 2 prior lines of systemic therapy.